Overview of salaries statistics of the profession "Director Of Operations in UK"

Location: United States - Fort Washington, PA, or Cary NC  Schedule: Full-time, Permanent     ClinChoice, the parent company of CROMSOURCE, is a leading full-service clinical CRO dedicated to offering high-quality one-stop services to pharmaceutical, biotechnology, medical device, and consumer products clients, who are dedicated to the professional development of our employees and providing an excellent work-life balance. We are looking for a dynamic person to join our in-house team as an Executive Director of Human Resources in the United States. This role will be office based in either Fort Washington, PA or Cary, NC with flexibility to work from home two days per week. Previous experience with a CRO is required.        The Executive Director of Human Resources will manage day-to-day HR operations in North America and provide strategic leadership and direction to the HR department. This position will be involved in every aspect of Human Resources function in North America including but not limited to organizational HR policy and compliance, talent management, employee relations, performance and benefit reviews, compensation, and other duties as assigned. Additionally, the position will work with the Global Head of HR and other HR Regional Heads to set strategy and ensure standardization and collaboration across the international organization of ClinChoice.     Join our team and help us deliver clinical trials that will improve patients' lives.       Main Job Tasks and Responsibilities:Lead and oversee day-to-day activities for HR functions in North America, including but not limited to HR system evaluation and implementation, HR core functions such as performance review and compensation, benefit, training requirements, terminations, onboarding and offboarding, etc.Lead the development and implementation of HR procedures and policies, and ensure the policies are in compliance with their respective country and local labor laws including health and safety, equal employment opportunity, diversity and inclusion, compensation and benefit requirements, pension plans, taxes, privacy, and any other laws.Team up with the recruitment group to develop cost-effective recruitment strategies and long-term talent acquisition plans to support the company's overall goal and look for creative solutions to meet fast-growing resource needs.Collaborate with other regional HR leads for alignment of the strategies and processes across the international organizations.Collaborate with and support the functional management team to ensure satisfactory employee retention.Prepare and present regularly or as needed to the International HR management team and update North America regional HR and initiatives. Support and contribute to the HR dashboard as needed. Education and Experience:A bachelor's degree in human resources or other fields is required. An MBA or master's degree in human resources or business is preferred.Thorough knowledge of North American (USA and Canada, particularly) employment-related laws and regulations.Experience with human resource information systems.10+ years of experience in Human Resources.  3+ years of leadership roles and team management in Human Resources in North America.Experience in HR management systems, such as ADP, SAP, or other systems.Experience working in a fast-paced, collaborative team environment. Able to work efficiently under pressure and consistently meet tight deadlines.Experience working for a CRO is required. Specific Role Requirements and Skills:Ability to be discreet and handle confidential, sensitive information.Excellent verbal and written communication skills, including presentation skills.Excellent interpersonal and conflict resolution skills.Excellent organizational skills and attention to detail.Strong analytical and problem-solving skills.Strong supervisory and leadership skills.Excellent in Microsoft Word, Excel, PowerPoint, Outlook. The Application Process  Once you have submitted your CV, you will receive an acknowledgment email. If you have the requirements we need, you will be invited for a phone interview as the first step.        If you would like to discuss the role before applying through the website @ www.cromsource.com/careers/job-vacancies please contact [email protected] for more information.     Who will you be working for?     About CROMSOURCE     CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                      Our Company Ethos  Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values are evidenced by our below-industry average turnover rates.     CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.     Keywords: Executive Director of Human Resources, HR Director, HR Manager, Human Resources, Human Resources Director, Human Resources Manager, Compliance, Employee relations management, Recruiting, Retention strategy, HR management, Employment law, Onboarding Management, ADP, SAP, Human Resource Information Systems, HRISSkills: HR Manager, Clinical Research Organisation, CROLocation: United StatesShare: LinkedIn Facebook Twitter Email

Location: Poland - home-based    Schedule: Full-time, permanent         CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a Director Regulatory Strategy, CMC to join our internal team.         As Director of Regulatory Strategy - CMC, you will be responsible for leading and managing regulatory strategy engagements with our clients, providing strategic guidance, and ensuring compliance with global regulatory requirements. You will serve as the primary regulatory point of contact for our clients, establishing and maintaining strong relationships while delivering exceptional service and regulatory solutions. Your expertise in CMC will enable you to competently communicate with clients concerning CMC activities, providing guidance while working with our global team to develop, review, and execute tailored regulatory strategies that support our clients' product development, registration, and post-approval activities.       Join our team and help us deliver clinical trials that will improve patients' lives.         Main Job Tasks and Responsibilities:Serve as the primary regulatory point of contact for clients, fostering strong relationships, understanding their regulatory needs, and providing expert guidance throughout the regulatory process.Collaborate with clients to develop and implement strategic regulatory plans for their products, focusing on CMC aspects, to support successful regulatory submissions and approvals.Provide expert guidance and interpretation of global regulatory requirements, guidelines, and industry best practices related to CMC, ensuring compliance in clients' regulatory strategies.Lead and manage client engagements, including project scoping, timelines, resource allocation, and deliverable management, while ensuring exceptional client service and satisfactionConduct regulatory assessments and gap analyses for clients' products, identifying potential regulatory risks, challenges, and opportunities, and providing strategic recommendations.Prepare and review CMC documentation, including drug substance and drug product specifications, manufacturing processes, stability data, and quality control strategies, to ensure compliance with regulatory standards.Lead and support the preparation and submission of CMC sections for regulatory filings, including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval submissions, ensuring high-quality and timely delivery.Stay current with global regulatory trends, changes, and evolving requirements in CMC, and proactively communicate updates to clients, guiding them on necessary adaptations.Represent the company at client meetings, regulatory agency interactions, and industry conferences, effectively communicating regulatory strategies, addressing inquiries, and building credibility and partnerships.Collaborate cross-functionally with internal teams, such as Medical Affairs, Safety, and Clinical Operations, to ensure alignment and seamless execution of clients' regulatory strategies.Participate in preparing written and presented bid developments for new clients.Prepare and present client metrics as needed.Identify opportunities for business growth to ensure on-going client support and positive engagement.Provide input on business strategic plans and managing outcome.Understand project scope of work and contract negotiation to identify when contracts need to be updated and ensure that SOW is being met throughout the project lifetime.Mentor and provide guidance to junior regulatory professionals, fostering their professional growth and ensuring high-quality work.Continuously assess and improve internal regulatory processes, tools, and systems to enhance operational efficiency and regulatory service delivery.Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies that can create business opportunities for the organization.Monitor Regulatory environment and communicate any changes and impact assessments to all team members. Education and Experience:Bachelors or Masters degree in a scientific field.Extensive experience (at least 15 years) in regulatory affairs, with a strong focus on CMC, within the pharmaceutical or biotechnology industry.Small molecule or biologics experience.Proven track record of successfully developing and executing regulatory strategies for complex global drug development programs.Exceptional client relationship management skills, with experience in a client-facing role, and the ability to understand and address client needs effectively.Strong understanding of drug development processes, regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval activities.Leadership experience, including the ability to lead and mentor a team of regulatory professionals. Specific Role Requirements and Skills:Excellent communication, negotiation, and presentation skills, with the ability to influence and build relationships with clients, regulatory agencies, and internal stakeholders.Strong analytical and problem-solving skills, with the ability to think strategically and make sound decisions in complex regulatory environments.Proficiency in using regulatory systems, databases, and software.Established leadership and management skills with cross-functional teams in a matrixed organizational structure.Business and strategic orientation, development of people, and processes.Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups. The Benefits of Working in Poland:Internet compensation of up to PLN 80 per monthInsurances: Group Accident (employer funded), medical care, and social fund (as per Polish regulations)PPK Pension participation (as per Polish regulations)Meal VouchersFlexible working hoursOccasional work from homeHolidays: Between 20 and 26 days per year, depending on seniorityRefund on corrective glasses for computer work (as per Polish regulations)Annual Christmas partySeniority Bonus (5y-1.000PLN, 10y-2.000PLN,15y-3.000PLN, 20y-4.000PLN)  The Application Process    Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.      If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs or please contact [email protected] for more information.         Who will you be working for?         About CROMSOURCE          CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                          Our Company Ethos    Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.         CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.         Keywords: Director Regulatory Strategy, Director Regulatory Strategy, CMC, Senior Manager Regulatory Strategy, CMC, CMC Regulatory Affairs, CMC Regulatory Affairs Director, Senior Manager CMC Regulatory Affairs, Regulatory, CRO, Contract Research OrganisationSkills: Strategy Lead, CMC, CRO, Outsourcing, Regulatory, Regulatory OperationsLocation: PolandShare: LinkedIn Facebook Twitter Email

Location: Spain - home-based    Schedule: Full-time, permanent         CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a Director Regulatory Strategy, CMC to join our internal team.         As Director of Regulatory Strategy - CMC, you will be responsible for leading and managing regulatory strategy engagements with our clients, providing strategic guidance, and ensuring compliance with global regulatory requirements. You will serve as the primary regulatory point of contact for our clients, establishing and maintaining strong relationships while delivering exceptional service and regulatory solutions. Your expertise in CMC will enable you to competently communicate with clients concerning CMC activities, providing guidance while working with our global team to develop, review, and execute tailored regulatory strategies that support our clients' product development, registration, and post-approval activities.       Join our team and help us deliver clinical trials that will improve patients' lives.         Main Job Tasks and Responsibilities:Serve as the primary regulatory point of contact for clients, fostering strong relationships, understanding their regulatory needs, and providing expert guidance throughout the regulatory process.Collaborate with clients to develop and implement strategic regulatory plans for their products, focusing on CMC aspects, to support successful regulatory submissions and approvals.Provide expert guidance and interpretation of global regulatory requirements, guidelines, and industry best practices related to CMC, ensuring compliance in clients' regulatory strategies.Lead and manage client engagements, including project scoping, timelines, resource allocation, and deliverable management, while ensuring exceptional client service and satisfactionConduct regulatory assessments and gap analyses for clients' products, identifying potential regulatory risks, challenges, and opportunities, and providing strategic recommendations.Prepare and review CMC documentation, including drug substance and drug product specifications, manufacturing processes, stability data, and quality control strategies, to ensure compliance with regulatory standards.Lead and support the preparation and submission of CMC sections for regulatory filings, including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval submissions, ensuring high-quality and timely delivery.Stay current with global regulatory trends, changes, and evolving requirements in CMC, and proactively communicate updates to clients, guiding them on necessary adaptations.Represent the company at client meetings, regulatory agency interactions, and industry conferences, effectively communicating regulatory strategies, addressing inquiries, and building credibility and partnerships.Collaborate cross-functionally with internal teams, such as Medical Affairs, Safety, and Clinical Operations, to ensure alignment and seamless execution of clients' regulatory strategies.Participate in preparing written and presented bid developments for new clients.Prepare and present client metrics as needed.Identify opportunities for business growth to ensure on-going client support and positive engagement.Provide input on business strategic plans and managing outcome.Understand project scope of work and contract negotiation to identify when contracts need to be updated and ensure that SOW is being met throughout the project lifetime.Mentor and provide guidance to junior regulatory professionals, fostering their professional growth and ensuring high-quality work.Continuously assess and improve internal regulatory processes, tools, and systems to enhance operational efficiency and regulatory service delivery.Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies that can create business opportunities for the organization.Monitor Regulatory environment and communicate any changes and impact assessments to all team members. Education and Experience:Bachelors or Master's degree in a scientific field.Extensive experience (at least 15 years) in regulatory affairs, with a strong focus on CMC, within the pharmaceutical or biotechnology industry.Small molecule or biologics experience.Proven track record of successfully developing and executing regulatory strategies for complex global drug development programs.Exceptional client relationship management skills, with experience in a client-facing role, and the ability to understand and address client needs effectively.Strong understanding of drug development processes, regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval activities.Leadership experience, including the ability to lead and mentor a team of regulatory professionals. Specific Role Requirements and Skills:Excellent communication, negotiation, and presentation skills, with the ability to influence and build relationships with clients, regulatory agencies, and internal stakeholders.Strong analytical and problem-solving skills, with the ability to think strategically and make sound decisions in complex regulatory environments.Proficiency in using regulatory systems, databases, and software.Established leadership and management skills with cross-functional teams in a matrixed organizational structure.Business and strategic orientation, development of people, and processes.Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups. The Benefits of Working in Spain:Competitive SalaryHealth insuranceHome office allowanceMeal vouchers23 days of holiday per year + 2 convenio days and bank holidays  The Application Process    Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.      If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs or please contact mailto [email protected] for more information.     Who will you be working for?         About CROMSOURCE          CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                          Our Company Ethos    Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.         CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.         Keywords: Director Regulatory Strategy, Director Regulatory Strategy, CMC, Senior Manager Regulatory Strategy, CMC, CMC Regulatory Affairs, CMC Regulatory Affairs Director, Senior Manager CMC Regulatory Affairs, Regulatory, CRO, Contract Research OrganisationSkills: Strategy Lead, CRO, Outsourcing, Regulatory, Regulatory OperationsLocation: SpainShare: LinkedIn Facebook Twitter Email

Location: Italy - home-based    Schedule: Full-time, permanent         CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a Director Regulatory Strategy, CMC to join our internal team.         As Director of Regulatory Strategy - CMC, you will be responsible for leading and managing regulatory strategy engagements with our clients, providing strategic guidance, and ensuring compliance with global regulatory requirements. You will serve as the primary regulatory point of contact for our clients, establishing and maintaining strong relationships while delivering exceptional service and regulatory solutions. Your expertise in CMC will enable you to competently communicate with clients concerning CMC activities, providing guidance while working with our global team to develop, review, and execute tailored regulatory strategies that support our clients' product development, registration, and post-approval activities.       Join our team and help us deliver clinical trials that will improve patients' lives.         Main Job Tasks and Responsibilities:Serve as the primary regulatory point of contact for clients, fostering strong relationships, understanding their regulatory needs, and providing expert guidance throughout the regulatory process.Collaborate with clients to develop and implement strategic regulatory plans for their products, focusing on CMC aspects, to support successful regulatory submissions and approvals.Provide expert guidance and interpretation of global regulatory requirements, guidelines, and industry best practices related to CMC, ensuring compliance in clients' regulatory strategies.Lead and manage client engagements, including project scoping, timelines, resource allocation, and deliverable management, while ensuring exceptional client service and satisfactionConduct regulatory assessments and gap analyses for clients' products, identifying potential regulatory risks, challenges, and opportunities, and providing strategic recommendations.Prepare and review CMC documentation, including drug substance and drug product specifications, manufacturing processes, stability data, and quality control strategies, to ensure compliance with regulatory standards.Lead and support the preparation and submission of CMC sections for regulatory filings, including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval submissions, ensuring high-quality and timely delivery.Stay current with global regulatory trends, changes, and evolving requirements in CMC, and proactively communicate updates to clients, guiding them on necessary adaptations.Represent the company at client meetings, regulatory agency interactions, and industry conferences, effectively communicating regulatory strategies, addressing inquiries, and building credibility and partnerships.Collaborate cross-functionally with internal teams, such as Medical Affairs, Safety, and Clinical Operations, to ensure alignment and seamless execution of clients' regulatory strategies.Participate in preparing written and presented bid developments for new clients.Prepare and present client metrics as needed.Identify opportunities for business growth to ensure on-going client support and positive engagement.Provide input on business strategic plans and managing outcome.Understand project scope of work and contract negotiation to identify when contracts need to be updated and ensure that SOW is being met throughout the project lifetime.Mentor and provide guidance to junior regulatory professionals, fostering their professional growth and ensuring high-quality work.Continuously assess and improve internal regulatory processes, tools, and systems to enhance operational efficiency and regulatory service delivery.Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies that can create business opportunities for the organization.Monitor Regulatory environment and communicate any changes and impact assessments to all team members. Education and Experience:Bachelors or Masters degree in a scientific field.Extensive experience (at least 15 years) in regulatory affairs, with a strong focus on CMC, within the pharmaceutical or biotechnology industry.Small molecule or biologics experience.Proven track record of successfully developing and executing regulatory strategies for complex global drug development programs.Exceptional client relationship management skills, with experience in a client-facing role, and the ability to understand and address client needs effectively.Strong understanding of drug development processes, regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval activities.Leadership experience, including the ability to lead and mentor a team of regulatory professionals. Specific Role Requirements and Skills:Excellent communication, negotiation, and presentation skills, with the ability to influence and build relationships with clients, regulatory agencies, and internal stakeholders.Strong analytical and problem-solving skills, with the ability to think strategically and make sound decisions in complex regulatory environments.Proficiency in using regulatory systems, databases, and software.Established leadership and management skills with cross-functional teams in a matrixed organizational structure.Business and strategic orientation, development of people, and processes.Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups. The Benefits of Working in Italy:Meal vouchersMobile phone if requested by the Line ManagerDedicated Line ManagerMonthly meetings with the line managerFull performance and development process with end-of-year reviews  The Application Process    Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.      If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs or please contact [email protected] for more information.         Who will you be working for?         About CROMSOURCE          CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                          Our Company Ethos    Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.         CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.         Keywords: Director Regulatory Strategy, Director Regulatory Strategy, CMC, Senior Manager Regulatory Strategy, CMC, CMC Regulatory Affairs, CMC Regulatory Affairs Director, Senior Manager CMC Regulatory Affairs, Regulatory, CRO, Contract Research OrganisationSkills: Strategy Lead, CMC, CRO, Outsourcing, RegulatoryLocation: ItalyShare: LinkedIn Facebook Twitter Email

Location: Netherlands - home-based    Schedule: Full-time, permanent     CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a Director Regulatory Strategy, CMC to join our internal team.       As Director of Regulatory Strategy - CMC, you will be responsible for leading and managing regulatory strategy engagements with our clients, providing strategic guidance, and ensuring compliance with global regulatory requirements. You will serve as the primary regulatory point of contact for our clients, establishing and maintaining strong relationships while delivering exceptional service and regulatory solutions. Your expertise in CMC will enable you to competently communicate with clients concerning CMC activities, providing guidance while working with our global team to develop, review, and execute tailored regulatory strategies that support our clients' product development, registration, and post-approval activities.     Join our team and help us deliver clinical trials that will improve patients' lives.       Main Job Tasks and Responsibilities:Serve as the primary regulatory point of contact for clients, fostering strong relationships, understanding their regulatory needs, and providing expert guidance throughout the regulatory process.Collaborate with clients to develop and implement strategic regulatory plans for their products, focusing on CMC aspects, to support successful regulatory submissions and approvals.Provide expert guidance and interpretation of global regulatory requirements, guidelines, and industry best practices related to CMC, ensuring compliance in clients' regulatory strategies.Lead and manage client engagements, including project scoping, timelines, resource allocation, and deliverable management, while ensuring exceptional client service and satisfactionConduct regulatory assessments and gap analyses for clients' products, identifying potential regulatory risks, challenges, and opportunities, and providing strategic recommendations.Prepare and review CMC documentation, including drug substance and drug product specifications, manufacturing processes, stability data, and quality control strategies, to ensure compliance with regulatory standards.Lead and support the preparation and submission of CMC sections for regulatory filings, including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval submissions, ensuring high-quality and timely delivery.Stay current with global regulatory trends, changes, and evolving requirements in CMC, and proactively communicate updates to clients, guiding them on necessary adaptations.Represent the company at client meetings, regulatory agency interactions, and industry conferences, effectively communicating regulatory strategies, addressing inquiries, and building credibility and partnerships.Collaborate cross-functionally with internal teams, such as Medical Affairs, Safety, and Clinical Operations, to ensure alignment and seamless execution of clients' regulatory strategies.Participate in preparing written and presented bid developments for new clients.Prepare and present client metrics as needed.Identify opportunities for business growth to ensure on-going client support and positive engagement.Provide input on business strategic plans and managing outcome.Understand project scope of work and contract negotiation to identify when contracts need to be updated and ensure that SOW is being met throughout the project lifetime.Mentor and provide guidance to junior regulatory professionals, fostering their professional growth and ensuring high-quality work.Continuously assess and improve internal regulatory processes, tools, and systems to enhance operational efficiency and regulatory service delivery.Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies that can create business opportunities for the organization.Monitor Regulatory environment and communicate any changes and impact assessments to all team members. Education and Experience:Bachelors or Masters degree in a scientific field.Extensive experience (at least 15 years) in regulatory affairs, with a strong focus on CMC, within the pharmaceutical or biotechnology industry.Small molecule or biologics experience.Proven track record of successfully developing and executing regulatory strategies for complex global drug development programs.Exceptional client relationship management skills, with experience in a client-facing role, and the ability to understand and address client needs effectively.Strong understanding of drug development processes, regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval activities.Leadership experience, including the ability to lead and mentor a team of regulatory professionals. Specific Role Requirements and Skills:Excellent communication, negotiation, and presentation skills, with the ability to influence and build relationships with clients, regulatory agencies, and internal stakeholders.Strong analytical and problem-solving skills, with the ability to think strategically and make sound decisions in complex regulatory environments.Proficiency in using regulatory systems, databases, and software.Established leadership and management skills with cross-functional teams in a matrixed organizational structure.Business and strategic orientation, development of people, and processes.Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups. The Benefits of Working in the Netherlands:Competitive SalaryGroup health insuranceGreat pension scheme24 vacation days (but up to 30 days, depending on negotiation)Internet reimbursementCompany Car with fuel card depending on the function.Full performance and development process with end-of-year reviews The Application Process    Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.    If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs or please contact [email protected] for more information.         Who will you be working for?         About CROMSOURCE         CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                        Our Company Ethos    Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.         CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.         Keywords: Director Regulatory Strategy, Director Regulatory Strategy, CMC, Senior Manager Regulatory Strategy, CMC, CMC Regulatory Affairs, CMC Regulatory Affairs Director, Senior Manager CMC Regulatory Affairs, Regulatory, CRO, Contract Research OrganisationSkills: Regulatory Affairs Director, Strategy Lead, Clinical Research Organisation, CRO, Regulatory, Regulatory OperationsLocation: NetherlandsShare: LinkedIn Facebook Twitter Email

Location: Germany - home-based    Schedule: Full-time, permanent         CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a Director Regulatory Strategy, CMC to join our internal team.         As Director of Regulatory Strategy - CMC, you will be responsible for leading and managing regulatory strategy engagements with our clients, providing strategic guidance, and ensuring compliance with global regulatory requirements. You will serve as the primary regulatory point of contact for our clients, establishing and maintaining strong relationships while delivering exceptional service and regulatory solutions. Your expertise in CMC will enable you to competently communicate with clients concerning CMC activities, providing guidance while working with our global team to develop, review, and execute tailored regulatory strategies that support our clients' product development, registration, and post-approval activities.       Join our team and help us deliver clinical trials that will improve patients' lives.         Main Job Tasks and Responsibilities:Serve as the primary regulatory point of contact for clients, fostering strong relationships, understanding their regulatory needs, and providing expert guidance throughout the regulatory process.Collaborate with clients to develop and implement strategic regulatory plans for their products, focusing on CMC aspects, to support successful regulatory submissions and approvals.Provide expert guidance and interpretation of global regulatory requirements, guidelines, and industry best practices related to CMC, ensuring compliance in clients' regulatory strategies.Lead and manage client engagements, including project scoping, timelines, resource allocation, and deliverable management, while ensuring exceptional client service and satisfactionConduct regulatory assessments and gap analyses for clients' products, identifying potential regulatory risks, challenges, and opportunities, and providing strategic recommendations.Prepare and review CMC documentation, including drug substance and drug product specifications, manufacturing processes, stability data, and quality control strategies, to ensure compliance with regulatory standards.Lead and support the preparation and submission of CMC sections for regulatory filings, including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval submissions, ensuring high-quality and timely delivery.Stay current with global regulatory trends, changes, and evolving requirements in CMC, and proactively communicate updates to clients, guiding them on necessary adaptations.Represent the company at client meetings, regulatory agency interactions, and industry conferences, effectively communicating regulatory strategies, addressing inquiries, and building credibility and partnerships.Collaborate cross-functionally with internal teams, such as Medical Affairs, Safety, and Clinical Operations, to ensure alignment and seamless execution of clients' regulatory strategies.Participate in preparing written and presented bid developments for new clients.Prepare and present client metrics as needed.Identify opportunities for business growth to ensure on-going client support and positive engagement.Provide input on business strategic plans and managing outcome.Understand project scope of work and contract negotiation to identify when contracts need to be updated and ensure that SOW is being met throughout the project lifetime.Mentor and provide guidance to junior regulatory professionals, fostering their professional growth and ensuring high-quality work.Continuously assess and improve internal regulatory processes, tools, and systems to enhance operational efficiency and regulatory service delivery.Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies that can create business opportunities for the organization.Monitor Regulatory environment and communicate any changes and impact assessments to all team members. Education and Experience:Bachelors or Masters degree in a scientific field.Extensive experience (at least 15 years) in regulatory affairs, with a strong focus on CMC, within the pharmaceutical or biotechnology industry.Small molecule or biologics experience.Proven track record of successfully developing and executing regulatory strategies for complex global drug development programs.Exceptional client relationship management skills, with experience in a client-facing role, and the ability to understand and address client needs effectively.Strong understanding of drug development processes, regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval activities.Leadership experience, including the ability to lead and mentor a team of regulatory professionals. Specific Role Requirements and Skills:Excellent communication, negotiation, and presentation skills, with the ability to influence and build relationships with clients, regulatory agencies, and internal stakeholders.Strong analytical and problem-solving skills, with the ability to think strategically and make sound decisions in complex regulatory environments.Proficiency in using regulatory systems, databases, and software.Established leadership and management skills with cross-functional teams in a matrixed organizational structure.Business and strategic orientation, development of people, and processes.Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups. The Benefits of Working in Germany:30 Euro net Internet cost reimbursement per monthAdditional Accident Insurance, fully covered by the company25 vacation daysPossibility of salary conversion for additional pension insuranceDedicated Line Manager The Application Process    Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.      If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs or please contact [email protected] for more information.         Who will you be working for?         About CROMSOURCE          CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                          Our Company Ethos    Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.         CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.         Keywords: Director Regulatory Strategy, Director Regulatory Strategy, CMC, Senior Manager Regulatory Strategy, CMC, CMC Regulatory Affairs, CMC Regulatory Affairs Director, Senior Manager CMC Regulatory Affairs, Regulatory, CRO, Contract Research OrganisationSkills: Regulatory Affairs Director, Strategy Lead, Clinical Research Organisation, CRO, Regulatory, Regulatory OperationsLocation: GermanyShare: LinkedIn Facebook Twitter Email

Location: Belgium - home-based    Schedule: Full-time, permanent     CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a Director Regulatory Strategy, CMC to join our internal team.       As Director of Regulatory Strategy - CMC, you will be responsible for leading and managing regulatory strategy engagements with our clients, providing strategic guidance, and ensuring compliance with global regulatory requirements. You will serve as the primary regulatory point of contact for our clients, establishing and maintaining strong relationships while delivering exceptional service and regulatory solutions. Your expertise in CMC will enable you to competently communicate with clients concerning CMC activities, providing guidance while working with our global team to develop, review, and execute tailored regulatory strategies that support our clients' product development, registration, and post-approval activities.     Join our team and help us deliver clinical trials that will improve patients' lives.       Main Job Tasks and Responsibilities:Serve as the primary regulatory point of contact for clients, fostering strong relationships, understanding their regulatory needs, and providing expert guidance throughout the regulatory process.Collaborate with clients to develop and implement strategic regulatory plans for their products, focusing on CMC aspects, to support successful regulatory submissions and approvals.Provide expert guidance and interpretation of global regulatory requirements, guidelines, and industry best practices related to CMC, ensuring compliance in clients' regulatory strategies.Lead and manage client engagements, including project scoping, timelines, resource allocation, and deliverable management, while ensuring exceptional client service and satisfactionConduct regulatory assessments and gap analyses for clients' products, identifying potential regulatory risks, challenges, and opportunities, and providing strategic recommendations.Prepare and review CMC documentation, including drug substance and drug product specifications, manufacturing processes, stability data, and quality control strategies, to ensure compliance with regulatory standards.Lead and support the preparation and submission of CMC sections for regulatory filings, including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval submissions, ensuring high-quality and timely delivery.Stay current with global regulatory trends, changes, and evolving requirements in CMC, and proactively communicate updates to clients, guiding them on necessary adaptations.Represent the company at client meetings, regulatory agency interactions, and industry conferences, effectively communicating regulatory strategies, addressing inquiries, and building credibility and partnerships.Collaborate cross-functionally with internal teams, such as Medical Affairs, Safety, and Clinical Operations, to ensure alignment and seamless execution of clients' regulatory strategies.Participate in preparing written and presented bid developments for new clients.Prepare and present client metrics as needed.Identify opportunities for business growth to ensure on-going client support and positive engagement.Provide input on business strategic plans and managing outcome.Understand project scope of work and contract negotiation to identify when contracts need to be updated and ensure that SOW is being met throughout the project lifetime.Mentor and provide guidance to junior regulatory professionals, fostering their professional growth and ensuring high-quality work.Continuously assess and improve internal regulatory processes, tools, and systems to enhance operational efficiency and regulatory service delivery.Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies that can create business opportunities for the organization.Monitor Regulatory environment and communicate any changes and impact assessments to all team members. Education and Experience:Bachelors or Masters degree in a scientific field.Extensive experience (at least 15 years) in regulatory affairs, with a strong focus on CMC, within the pharmaceutical or biotechnology industry.Small molecule or biologics experience.Proven track record of successfully developing and executing regulatory strategies for complex global drug development programs.Exceptional client relationship management skills, with experience in a client-facing role, and the ability to understand and address client needs effectively.Strong understanding of drug development processes, regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval activities.Leadership experience, including the ability to lead and mentor a team of regulatory professionals. Specific Role Requirements and Skills:Excellent communication, negotiation, and presentation skills, with the ability to influence and build relationships with clients, regulatory agencies, and internal stakeholders.Strong analytical and problem-solving skills, with the ability to think strategically and make sound decisions in complex regulatory environments.Proficiency in using regulatory systems, databases, and software.Established leadership and management skills with cross-functional teams in a matrixed organizational structure.Business and strategic orientation, development of people, and processes.Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups. The Benefits of Working in Belgium:Competitive SalaryGroup and hospitalisation insuranceElectronic meal vouchersInternet reimbursementCompany Car with fuel card depending on the function.Dedicated Line Manager The Application Process    Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.    If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs or please contact [email protected] for more information.         Who will you be working for?         About CROMSOURCE         CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                        Our Company Ethos    Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.         CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.         Keywords: Director Regulatory Strategy, Director Regulatory Strategy, CMC, Senior Manager Regulatory Strategy, CMC, CMC Regulatory Affairs, CMC Regulatory Affairs Director, Senior Manager CMC Regulatory Affairs, Regulatory, CRO, Contract Research OrganisationSkills: Regulatory Affairs Director, Strategy Lead, Clinical Research Organisation, CRO, Regulatory, Regulatory OperationsLocation: BelgiumShare: LinkedIn Facebook Twitter Email

Location: United Kingdom - Hybrid (2 days in office)Schedule: Full-time, permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Senior Director, Pharmacovigilance Operations. The Senior Director of Pharmacovigilance Operations will be responsible for delivering pharmacovigilance services to global clients. The Pharmacovigilance team is responsible for supporting a diverse range of clients (pharmaceutical, biotechnology, OTCs, medical devices, and consumer), working closely with Global Delivery Centers in North America, Europe, and Asia to provide services to global clients. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Ensures the Pharmacovigilance team manages client projects as per the contractual agreements and delivers high-quality services.Collaborates with the Global Head of PV and provides oversight and guidance to global team and delivery centers for projects which include but are not limited to Signal detection and evaluation, Literature Management, Safety Surveillance, Aggregate Reports, Risk Management Plans, ICSRs (PV Case Processing), Audit Support, Safety Management for Clinical Trials, Medical Writing, Other PV SupportBalancing resource requirements across the clients and promoting a pragmatic, flexible, and focused approach to workload.Collaborates and at times initiates process improvement projects by working with global teams.Provides progress of work plans and the status of key project deliverables.Identifies innovative solutions to meet clients' requirements and business objectives in partnership with global delivery teams and SMEs.Monitors, assesses the potential impact develops appropriate strategies for new or emerging regulations, and proposes new service offerings to the management team.Preparing bid-defense response for safety and clinical RFPs.Support sales activities such as bid-defense meetings, new client interactions, capabilities presentations, etc. for safety and clinical projects.Maintains strong relationships with existing clients and has a thorough understanding of our services.Leads/participates in client interactions and governance meetings.Advises on any new technology development and collaborates with internal team/external consultants to support the design and implementation of new technology. Education and Experience:Physician or PharmD or PhD in life sciences.The successful candidate will have 15-20 years of experience in drug safety (ICSR, periodic reporting, safety surveillance is a must) and a working knowledge of key pharmacovigilance regulations and methodologies.Experience in people management.Experience with CRO/BPO is preferred.Broad knowledge of clinical development and/or safety requirements from pre-clinical to post-marketing.Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team.The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information. Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                   Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates. About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously. CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.  Keywords: Senior Director, Pharmacovigilance Operations, Senior Director of Pharmacovigilance, Pharmacovigilance Operations, Senior Director, Medical Monitor, Monitor, Clinical Physician, Physician, ICH-GCP, Submissions, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, ICH-GCP, Submissions.Skills: Medical Monitor, Pharmacovigilance Manager, Pharmacovigilance Officer, clinical trials, ICH-GCP, PharmacovigilanceLocation: United KingdomShare: LinkedIn Facebook Twitter Email

Location: Belgium - Hybrid (2 days in office)Schedule: Full-time, permanent     CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Senior Director, Pharmacovigilance Operations.     The Senior Director of Pharmacovigilance Operations will be responsible for delivering pharmacovigilance services to global clients. The Pharmacovigilance team is responsible for supporting a diverse range of clients (pharmaceutical, biotechnology, OTCs, medical devices, and consumer), working closely with Global Delivery Centers in North America, Europe, and Asia to provide services to global clients.     Join our team and help us deliver clinical trials that will improve patients' lives.       Main Job Tasks and Responsibilities:Ensures the Pharmacovigilance team manages client projects as per the contractual agreements and delivers high-quality services.Collaborates with the Global Head of PV and provides oversight and guidance to global team and delivery centers for projects which include but are not limited to Signal detection and evaluation, Literature Management, Safety Surveillance, Aggregate Reports, Risk Management Plans, ICSRs (PV Case Processing), Audit Support, Safety Management for Clinical Trials, Medical Writing, Other PV SupportBalancing resource requirements across the clients and promoting a pragmatic, flexible, and focused approach to workload.Collaborates and at times initiates process improvement projects by working with global teams.Provides progress of work plans and the status of key project deliverables.Identifies innovative solutions to meet clients' requirements and business objectives in partnership with global delivery teams and SMEs.Monitors, assesses the potential impact develops appropriate strategies for new or emerging regulations, and proposes new service offerings to the management team.Preparing bid-defense response for safety and clinical RFPs.Support sales activities such as bid-defense meetings, new client interactions, capabilities presentations, etc. for safety and clinical projects.Maintains strong relationships with existing clients and has a thorough understanding of our services.Leads/participates in client interactions and governance meetings.Advises on any new technology development and collaborates with internal team/external consultants to support the design and implementation of new technology. Education and Experience:Physician or PharmD or PhD in life sciences.The successful candidate will have 15-20 years of experience in drug safety (ICSR, periodic reporting, safety surveillance is a must) and a working knowledge of key pharmacovigilance regulations and methodologies.Experience in people management.Experience with CRO/BPO is preferred.Broad knowledge of clinical development and/or safety requirements from pre-clinical to post-marketing.Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team.The Application Process  Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information.     Who will you be working for?     About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                    Our Company Ethos  Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates.     About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously.     CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.     Keywords: Senior Director, Pharmacovigilance Operations, Senior Director of Pharmacovigilance, Pharmacovigilance Operations, Senior Director, Medical Monitor, Monitor, Clinical Physician, Physician, ICH-GCP, Submissions, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, ICH-GCP, Submissions.Skills: Medical Monitor, Pharmacovigilance Manager, Pharmacovigilance Officer, clinical trials, ICH-GCP, PharmacovigilanceLocation: BelgiumShare: LinkedIn Facebook Twitter Email

Location: Italy - Hybrid (2 days in office)Schedule: Full-time, permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Senior Director, Pharmacovigilance Operations. The Senior Director of Pharmacovigilance Operations will be responsible for delivering pharmacovigilance services to global clients. The Pharmacovigilance team is responsible for supporting a diverse range of clients (pharmaceutical, biotechnology, OTCs, medical devices, and consumer), working closely with Global Delivery Centers in North America, Europe, and Asia to provide services to global clients. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Ensures the Pharmacovigilance team manages client projects as per the contractual agreements and delivers high-quality services.Collaborates with the Global Head of PV and provides oversight and guidance to global team and delivery centers for projects which include but are not limited to Signal detection and evaluation, Literature Management, Safety Surveillance, Aggregate Reports, Risk Management Plans, ICSRs (PV Case Processing), Audit Support, Safety Management for Clinical Trials, Medical Writing, Other PV SupportBalancing resource requirements across the clients and promoting a pragmatic, flexible, and focused approach to workload.Collaborates and at times initiates process improvement projects by working with global teams.Provides progress of work plans and the status of key project deliverables.Identifies innovative solutions to meet clients' requirements and business objectives in partnership with global delivery teams and SMEs.Monitors, assesses the potential impact develops appropriate strategies for new or emerging regulations, and proposes new service offerings to the management team.Preparing bid-defense response for safety and clinical RFPs.Support sales activities such as bid-defense meetings, new client interactions, capabilities presentations, etc. for safety and clinical projects.Maintains strong relationships with existing clients and has a thorough understanding of our services.Leads/participates in client interactions and governance meetings.Advises on any new technology development and collaborates with internal team/external consultants to support the design and implementation of new technology. Education and Experience:Physician or PharmD or PhD in life sciences.The successful candidate will have 15-20 years of experience in drug safety (ICSR, periodic reporting, safety surveillance is a must) and a working knowledge of key pharmacovigilance regulations and methodologies.Experience in people management.Experience with CRO/BPO is preferred.Broad knowledge of clinical development and/or safety requirements from pre-clinical to post-marketing.Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team.The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information. Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                  Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates. About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously.  CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Keywords: Senior Director, Pharmacovigilance Operations, Senior Director of Pharmacovigilance, Pharmacovigilance Operations, Senior Director, Medical Monitor, Monitor, Clinical Physician, Physician, ICH-GCP, Submissions, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, ICH-GCP, SubmissionsSkills: Medical Monitor, Pharmacovigilance Manager, Pharmacovigilance Officer, clinical trials, ICH-GCP, PharmacovigilanceLocation: ItalyShare: LinkedIn Facebook Twitter Email

Location: Spain - Hybrid (2 days in office)Schedule: Full-time, permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Senior Director, Pharmacovigilance Operations. The Senior Director of Pharmacovigilance Operations will be responsible for delivering pharmacovigilance services to global clients. The Pharmacovigilance team is responsible for supporting a diverse range of clients (pharmaceutical, biotechnology, OTCs, medical devices, and consumer), working closely with Global Delivery Centers in North America, Europe, and Asia to provide services to global clients. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Ensures the Pharmacovigilance team manages client projects as per the contractual agreements and delivers high-quality services.Collaborates with the Global Head of PV and provides oversight and guidance to global team and delivery centers for projects which include but are not limited to Signal detection and evaluation, Literature Management, Safety Surveillance, Aggregate Reports, Risk Management Plans, ICSRs (PV Case Processing), Audit Support, Safety Management for Clinical Trials, Medical Writing, Other PV SupportBalancing resource requirements across the clients and promoting a pragmatic, flexible, and focused approach to workload.Collaborates and at times initiates process improvement projects by working with global teams.Provides progress of work plans and the status of key project deliverables.Identifies innovative solutions to meet clients' requirements and business objectives in partnership with global delivery teams and SMEs.Monitors, assesses the potential impact develops appropriate strategies for new or emerging regulations, and proposes new service offerings to the management team.Preparing bid-defense response for safety and clinical RFPs.Support sales activities such as bid-defense meetings, new client interactions, capabilities presentations, etc. for safety and clinical projects.Maintains strong relationships with existing clients and has a thorough understanding of our services.Leads/participates in client interactions and governance meetings.Advises on any new technology development and collaborates with internal team/external consultants to support the design and implementation of new technology. Education and Experience:Physician or PharmD or PhD in life sciences.The successful candidate will have 15-20 years of experience in drug safety (ICSR, periodic reporting, safety surveillance is a must) and a working knowledge of key pharmacovigilance regulations and methodologies.Experience in people management.Experience with CRO/BPO is preferred.Broad knowledge of clinical development and/or safety requirements from pre-clinical to post-marketing.Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team.The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information. Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                   Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates. About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously.  CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.  Keywords: Senior Director, Pharmacovigilance Operations, Senior Director of Pharmacovigilance, Pharmacovigilance Operations, Senior Director, Medical Monitor, Monitor, Clinical Physician, Physician, ICH-GCP, Submissions, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, ICH-GCP, Submissions.Skills: Medical Monitor, Pharmacovigilance Manager, Pharmacovigilance Officer, clinical trials, ICH-GCP, PharmacovigilanceLocation: SpainShare: LinkedIn Facebook Twitter Email

Location: Netherlands - Hybrid (2 days in office)Schedule: Full-time, Permanent     CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Senior Director, Pharmacovigilance Operations.     The Senior Director of Pharmacovigilance Operations will be responsible for delivering pharmacovigilance services to global clients. The Pharmacovigilance team is responsible for supporting a diverse range of clients (pharmaceutical, biotechnology, OTCs, medical devices, and consumer), working closely with Global Delivery Centers in North America, Europe, and Asia to provide services to global clients.     Join our team and help us deliver clinical trials that will improve patients' lives.       Main Job Tasks and Responsibilities:Ensures the Pharmacovigilance team manages client projects as per the contractual agreements and delivers high-quality services.Collaborates with the Global Head of PV and provides oversight and guidance to global team and delivery centers for projects which include but are not limited to Signal detection and evaluation, Literature Management, Safety Surveillance, Aggregate Reports, Risk Management Plans, ICSRs (PV Case Processing), Audit Support, Safety Management for Clinical Trials, Medical Writing, Other PV SupportBalancing resource requirements across the clients and promoting a pragmatic, flexible, and focused approach to workload.Collaborates and at times initiates process improvement projects by working with global teams.Provides progress of work plans and the status of key project deliverables.Identifies innovative solutions to meet clients' requirements and business objectives in partnership with global delivery teams and SMEs.Monitors, assesses the potential impact develops appropriate strategies for new or emerging regulations, and proposes new service offerings to the management team.Preparing bid-defense response for safety and clinical RFPs.Support sales activities such as bid-defense meetings, new client interactions, capabilities presentations, etc. for safety and clinical projects.Maintains strong relationships with existing clients and has a thorough understanding of our services.Leads/participates in client interactions and governance meetings.Advises on any new technology development and collaborates with internal team/external consultants to support the design and implementation of new technology. Education and Experience:Physician or PharmD or PhD in life sciences.The successful candidate will have 15-20 years of experience in drug safety (ICSR, periodic reporting, safety surveillance is a must) and a working knowledge of key pharmacovigilance regulations and methodologies.Experience in people management.Experience with CRO/BPO is preferred.Broad knowledge of clinical development and/or safety requirements from pre-clinical to post-marketing.Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team.The Application Process  Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information.     Who will you be working for?     About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                    Our Company Ethos  Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates.     About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously.     CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.     Keywords: Senior Director, Pharmacovigilance Operations, Senior Director of Pharmacovigilance, Pharmacovigilance Operations, Senior Director, Medical Monitor, Monitor, Clinical Physician, Physician, ICH-GCP, Submissions, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, ICH-GCP, Submissions.Skills: Medical Monitor, Pharmacovigilance Manager, Pharmacovigilance Officer, clinical trials, ICH-GCP, PharmacovigilanceLocation: NetherlandsShare: LinkedIn Facebook Twitter Email

Location: Poland - Hybrid (2 days in office)Schedule: Full-time, permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Senior Director, Pharmacovigilance Operations. The Senior Director of Pharmacovigilance Operations will be responsible for delivering pharmacovigilance services to global clients. The Pharmacovigilance team is responsible for supporting a diverse range of clients (pharmaceutical, biotechnology, OTCs, medical devices, and consumer), working closely with Global Delivery Centers in North America, Europe, and Asia to provide services to global clients. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Ensures the Pharmacovigilance team manages client projects as per the contractual agreements and delivers high-quality services.Collaborates with the Global Head of PV and provides oversight and guidance to global team and delivery centers for projects which include but are not limited to Signal detection and evaluation, Literature Management, Safety Surveillance, Aggregate Reports, Risk Management Plans, ICSRs (PV Case Processing), Audit Support, Safety Management for Clinical Trials, Medical Writing, Other PV SupportBalancing resource requirements across the clients and promoting a pragmatic, flexible, and focused approach to workload.Collaborates and at times initiates process improvement projects by working with global teams.Provides progress of work plans and the status of key project deliverables.Identifies innovative solutions to meet clients' requirements and business objectives in partnership with global delivery teams and SMEs.Monitors, assesses the potential impact develops appropriate strategies for new or emerging regulations, and proposes new service offerings to the management team.Preparing bid-defense response for safety and clinical RFPs.Support sales activities such as bid-defense meetings, new client interactions, capabilities presentations, etc. for safety and clinical projects.Maintains strong relationships with existing clients and has a thorough understanding of our services.Leads/participates in client interactions and governance meetings.Advises on any new technology development and collaborates with internal team/external consultants to support the design and implementation of new technology. Education and Experience:Physician or PharmD or PhD in life sciences.The successful candidate will have 15-20 years of experience in drug safety (ICSR, periodic reporting, safety surveillance is a must) and a working knowledge of key pharmacovigilance regulations and methodologies.Experience in people management.Experience with CRO/BPO is preferred.Broad knowledge of clinical development and/or safety requirements from pre-clinical to post-marketing.Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team.The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information. Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                  Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates. About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously. CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Keywords: Senior Director, Pharmacovigilance Operations, Senior Director of Pharmacovigilance, Pharmacovigilance Operations, Senior Director, Medical Monitor, Monitor, Clinical Physician, Physician, ICH-GCP, Submissions, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, ICH-GCP, Submissions.Skills: Medical Monitor, Pharmacovigilance Manager, Pharmacovigilance Officer, clinical trials, ICH-GCP, PharmacovigilanceLocation: PolandShare: LinkedIn Facebook Twitter Email

Location: Germany - Hybrid (2 days in office)Schedule: Full-time, Permanent     CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Senior Director, Pharmacovigilance Operations.     The Senior Director of Pharmacovigilance Operations will be responsible for delivering pharmacovigilance services to global clients. The Pharmacovigilance team is responsible for supporting a diverse range of clients (pharmaceutical, biotechnology, OTCs, medical devices, and consumer), working closely with Global Delivery Centers in North America, Europe, and Asia to provide services to global clients.     Join our team and help us deliver clinical trials that will improve patients' lives.       Main Job Tasks and Responsibilities:Ensures the Pharmacovigilance team manages client projects as per the contractual agreements and delivers high-quality services.Collaborates with the Global Head of PV and provides oversight and guidance to global team and delivery centers for projects which include but are not limited to Signal detection and evaluation, Literature Management, Safety Surveillance, Aggregate Reports, Risk Management Plans, ICSRs (PV Case Processing), Audit Support, Safety Management for Clinical Trials, Medical Writing, Other PV SupportBalancing resource requirements across the clients and promoting a pragmatic, flexible, and focused approach to workload.Collaborates and at times initiates process improvement projects by working with global teams.Provides progress of work plans and the status of key project deliverables.Identifies innovative solutions to meet clients' requirements and business objectives in partnership with global delivery teams and SMEs.Monitors, assesses the potential impact develops appropriate strategies for new or emerging regulations, and proposes new service offerings to the management team.Preparing bid-defense response for safety and clinical RFPs.Support sales activities such as bid-defense meetings, new client interactions, capabilities presentations, etc. for safety and clinical projects.Maintains strong relationships with existing clients and has a thorough understanding of our services.Leads/participates in client interactions and governance meetings.Advises on any new technology development and collaborates with internal team/external consultants to support the design and implementation of new technology. Education and Experience:Physician or PharmD or PhD in life sciences.The successful candidate will have 15-20 years of experience in drug safety (ICSR, periodic reporting, safety surveillance is a must) and a working knowledge of key pharmacovigilance regulations and methodologies.Experience in people management.Experience with CRO/BPO is preferred.Broad knowledge of clinical development and/or safety requirements from pre-clinical to post-marketing.Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team.The Application Process  Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information.     Who will you be working for?     About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                    Our Company Ethos  Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates.     About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously.     CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.     Keywords: Senior Director, Pharmacovigilance Operations, Senior Director of Pharmacovigilance, Pharmacovigilance Operations, Senior Director, Medical Monitor, Monitor, Clinical Physician, Physician, ICH-GCP, Submissions, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials.Skills: Medical Monitor, Pharmacovigilance Manager, Pharmacovigilance Officer, clinical trials, ICH-GCP, PharmacovigilanceLocation: GermanyShare: LinkedIn Facebook Twitter Email

The AD of Commercial Operations will be responsible for 4 Heads of Service, managing voids and repairs, planned works, M&E and ground maintenance.Lead the internal maintenance service (DLO) to deliver a positive value for money and engaged customer experience.Take a strategic lead in the procurement and development of long term relationships with Sub-Contractors and Merchant suppliers.Ensure working practicies are effective and health and safety and safeguarding compliant.Manage risk associated to repair and capital investment works, ensuring the Director is informed regarding any areas of concern.Ensure the IMS and Contractors are compliant with H&S legislation, regulations and approved codes of practice.Update and review the IMS Business Plan with a commercial eye, translating this to annual financial and performance targets.Ensuring contractual and commercial arrangements across the IMS and its supply chain provide service infrastructure and logistics, enabling service delivery and value for money objectives to be met.Key contact for contractual matters.Management of procurement and tender activities within the Directorate, including pre-qualification management, tender submission and pricing/negotiations, with appropriate engagement of emh's procurement team as required.Ensuring that all commercial risks are identified and adequality managed.Responsible person for CDM compliance across all workstreamsResponsible for operational statutory compliance related to large scale investment programmes and repairs serviceResponsible for safeguarding across all workstreamsIt is desirable that the successful candidate holds the following experience and qualifications.A degree, management qualification or relevant professional qualification preferably in construction/Asset Management.It is key that you hold a proven track record of demonstrating commercial acumen, developing strategic business plans to deliver a commercially focused model, budget management and achieving value for money whilst retaining excellent customer satisfaction.Proven experience of devising and implementing strategy related to the delivery of capital investment, decarbonisation, grounds maintenance and revenue work streams with a blended direct delivery and contractor model.Substantial experience of working within property management service, delivering effective, efficient value for money services.Significant senior management experience.

Job Details Our client is a US law firm, considered ‘an American juggernaut’ and highly recognised for their Private Equity work, they are now looking for a HR Operations Assistant to join their HR team in their London offices on a permanent basis. The HR Operations Assistant will be responsible supporting the HR Operations team, working with the Associate Director and the wider team to provide a seamless service to the firm’s divisions. Key Duties Include: Assisting with data entry in PeopleSoft for the London office, including processing new hires and leavers. Providing support to the Secretarial Services team in approving secretarial timesheets. Assist with monitoring and replying to emails sent to the London HR Operations mailbox. Assisting with enrolling new members in relevant benefits schemes; updating tracking information and maintaining relevant PeopleSoft screens. Assisting with the coordination of wellbeing events and promotional activities. Preparing expenses for the HR Operations team in line with the Firm procedures. The HR Operations Assistant must have previous experience working with HR systems specifically PeopleSoft. It is essential to demonstrate excellent attention to detail and time management skills along with strong numerical skills. The right candidate will maintain confidentiality, possess excellent organisational & communication skills – both verbal & written (dealing with people at various levels) and be a problem solver. The right candidate will be a flexible, resilient and confident. IMPORTANT NOTICE It is Career Legal’s policy, as a matter of courtesy to respond to all applications within three working days. However, because of the volume of applications, we are sometimes unable to respond to individual candidates. If we have not contacted you within three working days your application has been unsuccessful and your details have not been retained. Please apply for any other position that you may see in the future. Career Legal is a Recruitment Agency and is advertising this permanent vacancy on behalf of one of its Clients. Thank you. Our website For our application policy please view the link below. Career Legal is a Recruitment Business & Agency and is advertising this vacancy on behalf of one of its Clients. http://www.careerlegal.co.uk/application-policy

Job Description Operations Administrator Full Time London/Hybrid Why Rolls-Royce? An exciting opportunity has arisen for an Operations Administrator to join Rolls-Royce & Partners Finance (“RRPF”), Rolls-Royce & Partners Finance Limited (“RRPF”) is a jet engine leasing company with the largest global portfolio of Rolls-Royce and IAE V2500-A5 aero engines. We provide medium and long - term spare engine leasing and bespoke financial solutions to airlines, aircraft lessors and Original Equipment Manufacturers (OEMs) and support over 60 customers worldwide with a portfolio of over 500 jet engines. The role will sit within the Operations arm of the business which is a fast-paced team that is responsible for the day to day management of business, implementation of its transactions and business improvement activities. The successful candidate will need to be passionate about business improvement, have an eye for detail and work with a diverse mix of internal and external partners and customers. Work with us and we’ll welcome you into an inclusive culture, one that invests in your continuous learning and development, and gives you access to a wide breadth and depth of experience. We offer excellent development, a competitive salary, and exceptional benefits. These include bonus, employee support assistance and employee discounts. Your needs are as unique as you are. Hybrid working is a way in which our people can balance their time between the office, home or another remote location. It’s a locally managed and flexed informal discretionary arrangement. As a minimum we’re all expected to attend the workplace for collaboration and other specific reasons, on average three days per week. What you will be doing: In this role you will initiate business-wide engagement, understanding deficiencies, provide strategic direction and insight to identify areas of value creation and lead the business on quality improvements in all areas . You will also; Partake in the transformation of in-house created digital systems and commercial products for the global aviation industry To support effective resource planning, budget, suppliers/partners, management, reporting and coordination of projects/initiatives to deliver change Work with Operations Director to scope digital systems to support business transformation initiatives Ensure compliance with policies, procedures, guidelines and infrastructures that meet Group and Business governance and Commercial functional requirements. Maintain day to day relationship with internal (Rolls-Royce IT) and external system vendors Who we’re looking for: Being a part of Rolls-Royce you’ll know we embrace agility, are bold, pursue collaboration and seek simplicity in everything we do. These principles form our values and behaviours and are an essential component of our assessment process and are fundamental qualities that we seek for all roles. Able to quickly understand business processes and its requirements Affinity with process development and standardisation Strong work ethic, ability to work under time pressure, prioritise workload and meet deadlines Process oriented but able to use initiative and work outside of comfort zone Excellent organisational and communication skills (written and oral) Good IT skills We are an equal opportunities employer. We’re committed to developing a diverse team and an inclusive working environment. We believe that people from different backgrounds and cultures give us different perspectives. And the more perspectives we have, the more successful we’ll be. By building a culture of respect and appreciation, we give everyone who works here the opportunity to realise their full potential. We welcome applications from people with a refugee background. You can learn more about our global Inclusion strategy at Our people | Rolls-Royce Closing date : 20th November 2023 Job Category Secretarial / Clerical Posting Date 13 Nov 2023; 00:11

This role supports the CEO and is responsible for leading the financial strategy of the organisationManaging and mentoring the finance and purchasing functions to provide business partnering to other functions Making recommendations structurally and introduce process efficiencies across the business to ensure regular access to resources to fund innovation and projects delivering to strategic goalsSupporting income diversification and revenue (where appropriate) and the innovation leading to new income streamsEnsure statutory and legal financial compliance across all operationsLeading on the development of continuous improvement through the appropriate investment in the development of financial systems, services, analytics and automationPromotion of collaborative and cross functional working across the organisation on both new and existing projects and servicesQualified Accountant Experience as a number one finance lead Prior experience of working in a Not for Profit organisation or membership body Experience of Board level working in a charity environment.Exceptional judgement and decision-making skills particularly in the areas of financial management and risk.A detailed understanding of The Charity commission rules, and Charities SORP

Exciting opportunity for a Infrastructure Structured Finance Director - EMEA to join a European Corporate & Investment Bank. London- Project Finance, Infrastructure, Energy, TMT: Origination, Execution, Portfolio Management The role:Responsible for origination, structuring, execution and portfolio management of project finance and acquisition finance related transactions in the energy, infrastructure and TMT sectors, with coverage of the EMEA regionSupervise the transaction, portfolio and administrative activities & responsibilities of the vice presidents, associates and analystsLiaising and coordinating with internal stakeholdersMonitor the updating/validity of internal ratings, money laundering reassessment risk for the structured finance transactions allocated at a Transaction responsibility level as well as supervising the monitoring of periodic construction & operation reports, credit reviews plus waiver & amendment processing relating to their portfolio. Assist the person in charge of the portfolio with their information needsEnsuring an understanding of the requirements as a Certified Person.Exciting opportunity for a Infrastructure Structured Finance Director - EMEA to join a European Corporate & Investment Bank. London- Project Finance, Infrastructure, Energy, TMT: Origination, Execution, Portfolio Management The candidate:minimum 7-8 years experience in energy, infrastructure and TMT project finance and structured finance transactions, including due diligence, credit analysis, execution, modelling, documentation and administration Competencies RequiredA degree in finance, economics, accountingFormal credit trainingExtensive background in credit analysis and financial modellingpractical knowledge of financial products, finance, accounting, and documentation Proficient with MS Office Suite including MS Word, Excel, Power Point CompetenciesStrong credit, analytical and financial modelling skillsExceptional verbal and written communication skills to deal with a wide variety of internal and external counterpartsAbility to analyse and conduct independent due diligence of transactions, plus identify industry/market trendsAbility to act as a transaction manager / deal team coordinator for complex transactionsAdvisory experience a plus Team-oriented personality

Location: London, UK, Hybrid Introduction to TM Forum TM Forum is an association of over 700+ member companies, which include all of the world’s top 10 network and communications providers and stretch across 180 countries. Our members tap into each other’s collective experiences and abilities to collaboratively solve complex industry-wide challenges, deploy new services, and create technology breakthroughs to accelerate change. We help communications service providers (CSPs) and their suppliers to digitally transform and thrive in the digital era. We do this by providing an open, collaborative environment and practical support which enables CSPs and suppliers to rapidly transform their business operations, IT systems and ecosystems to capitalize on the opportunities presented in a rapidly evolving digital world. You can learn more at www.tmforum.org Our vision is to drive the next wave of digital business growth – the digitization of every industry – by providing a common innovation platform to connect businesses, industries, and ecosystems. We do this in a highly practical and agile way through collaboration programs and communities which lead to rapid prototypes – ranging from digital business models to interconnectivity APIs – that have real world commercial applications. Complementing our collaboration programs, the Forum provides thought-provoking digital business research and publications, industry best practices and standards along with training programs to accelerate adoption, and events and workshops which connect top business & IT leaders to learn, network, and develop meaningful partnerships. As TM Forum has continued to grow we are investing in our ability to support our global, diverse member community and internal team. This role will be a critical success factor in building out our operational capability to provide world-class service levels, improving our levels of automation and ensuring we proactively deal with cyber threats. The Support Team Lead will collaborate directly with our members and across the entire organisation. Are you ready to join a team that embodies ambition, courage, and passion in every endeavor? At TM Forum, we take pride in our core values, which drive our mission to digitally transform the world of communications. We're not just inclusive; we're a collaborative community that thrives on diversity. We do the right thing, always. If you're looking for a dynamic environment where innovation and teamwork are at the heart of everything we do, TM Forum is the place for you. Join us, and together, let's shape the future of the digital era. We are Ambitious, We are Brave, We are Passionate, We are Inclusive, We are Collaborative, and We always Do the Right Thing within TM Forum. Role Overview The Support Team Lead will be part of the Data Technology and Digital Experience team, reporting to the IT Operations Director. This role will have 2-3 direct reports and lead the team in supporting approximately 130 staff spread across the world but primarily in Western Europe and the US. Job Specification Lead and mentor the IT Operations team o Facilitate day to day management responsibilities including team support, feedback, planning and prioritization o Ensuring the team meets SLAs and KPIs; OKR/Goals delivery o Tracking individual performance and providing coaching Deliver operational excellence to our organization and customers utilizing our website o Work within our helpdesk and JIRA tools to track bugs, problems, and deploy solutions o Identify and implement process improvements, cost-savings, solutions and automation within team and larger organization o Review and update Disaster Recovery and ensure applications, servers and backup processes are effective and reliable. o Lead software roll-outs, upgrades, and updates o Assisting in preparation of departmental budget, monitor and control costs regarding equipment and online services o Overseeing equipment deployment to staff and events o Ensuring best practice security is being implemented and enforced; Identify and rectify security vulnerabilities o Lead system, account and security audits o Monitor and communicate system uptime o Part of an on-call schedule for hardware outages and software problems o Directing training and onboarding Collaborate within technology team and cross-functionally o Collaborate with development to ensure issues escalated by team are dealt with in a timely manner o Assist project management with execution of project deliverables o Work with managers across the organization to understand their requirements Person Specification General Bachelor Degree or equivalent in IT related field 10 years of experience in IT 2-5 years experience of IT leadership Desired: Any certifications in Security+; Cloud+; CITM; CISM; ITMLP; PMP; or similar Experience with Required: Office 365 – Exchange, Sharepoint, Teams Azure Ad Jira Desired: Salesforce AWS (EC2, S3, etc) Aventri RMM/MDM solutions Power Automate / Boomi / similar iPaaS REST API experience Some development knowledge or experience ISO 27001/SOC 2 compliance Miscellaneous Eagerness to learn new systems and skills Display strong leadership aptitude, ability to make decisions on the fly, work independently and work well with others Possess excellent communication skills and ability to communicate in professional manner with staff and customers The ability to interact across all levels of an organization and across a global environment, including some flexibility in hours Strong work ethic and ability to work on own initiative to apply knowledge and deliver solutions. Must have strong ability to plan, organize and prioritize work Proven ability to work in a busy environment to deadlines To apply To apply for this position, please send your Curriculum Vitae and a supporting letter explaining why you are the right person for the job, to [email protected] Diversity & Inclusion at TM Forum TM Forum is an Equal Opportunity Employer that does not discriminate based on actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, disability or handicap, sex, marital status, veteran status, sexual orientation, genetic information, arrest record, or any other characteristic protected by applicable federal, state, or local laws. Some flexible hours needed to accommodate team calls in different time zones. Our people are unique and many of our staff work flexibly in many ways. Please talk to us at interview about the flexibility you need. We can’t promise to give you exactly what you want, but we do promise not to judge you for asking.