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

Location: Europe - home-basedSchedule: 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 recruiting for a dynamic person to join our in-house team as a Director of Business Development - PV, MA & RA Services. You will be responsible for lead generation, opportunity assessment, creating new accounts, and growing existing accounts. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Identify, assess, and pursue new business opportunities.Build and maintain positive relationships and provide regular face time with key decision makers within prospect and client organizations.Develop a deep appreciation for the client's business challenges and organizational structure and use this insight to develop realistic and actionable account plans.Contribute to the ongoing refinement of the company's business development approach, defining client and vertical targets, minimizing the cost of sales, and increasing both efficiencies and closing rates.Work to exceed revenue targets that align with the company's growth objectives. Education and Experience:6+ years of sales and account management experienceExperience in functional and consultancy sales with a particular focus on Product Safety, Pharmacovigilance, Medical Affairs, and/or Regulatory AffairsEstablished a network of decision-makers in the life-sciences industry.Experience selling to, presenting to, and building relationships with senior management and C-level stakeholders.Strong negotiation skills with a proven track record of closing complex business dealsPersuasive and compelling presentation and communication skills, both written and verbalAbility to interpret business challenges and present quick and responsive high-level solutions.Deadline-driven with a proven ability to manage multiple engagements at varying points in the sales cycle.Positive employer and client referencesBA, MBA, or equivalent experience The Application ProcessOnce 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 EthosOur 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. 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: Director of Business Development, business development, marketing, contracting, travel, clinical trials, CRO, Clinical Research Organization, clinical development, CRO management, relationship management, clinical research sales, account managementSkills: Business Development Director, Business Development Manager, Clinical Research Associate, Business Development, clinical trials, CROLocation: EuropeShare: LinkedIn Facebook Twitter Email

Location: United Kingdom - home-basedSchedule: 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 recruiting for a dynamic person to join our in-house team as a Director of Business Development - PV, MA & RA Services. You will be responsible for lead generation, opportunity assessment, creating new accounts, and growing existing accounts. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Identify, assess, and pursue new business opportunities.Build and maintain positive relationships and provide regular face time with key decision makers within prospect and client organizations.Develop a deep appreciation for the client's business challenges and organizational structure and use this insight to develop realistic and actionable account plans.Contribute to the ongoing refinement of the company's business development approach, defining client and vertical targets, minimizing the cost of sales, and increasing both efficiencies and closing rates.Work to exceed revenue targets that align with the company's growth objectives. Education and Experience:6+ years of sales and account management experienceExperience in functional and consultancy sales with a particular focus on Product Safety, Pharmacovigilance, Medical Affairs, and/or Regulatory AffairsEstablished a network of decision-makers in the life-sciences industry.Experience selling to, presenting to, and building relationships with senior management and C-level stakeholders.Strong negotiation skills with a proven track record of closing complex business dealsPersuasive and compelling presentation and communication skills, both written and verbalAbility to interpret business challenges and present quick and responsive high-level solutions.Deadline-driven with a proven ability to manage multiple engagements at varying points in the sales cycle.Positive employer and client referencesBA, MBA, or equivalent experience Our Benefits: in the United KingdomPension contributionLife assurance25 days of holidaySeniority bonusCar allowance for defined rolesFull performance and development process with end-of-year reviewsCareer opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationallyEmployee satisfaction survey - your feedback is important for continuous improvement. The Application ProcessOnce 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 EthosOur 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. 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: Director of Business Development, business development, marketing, contracting, travel, clinical trials, CRO, Clinical Research Organization, clinical development, CRO management, relationship management, clinical research sales, account managementSkills: Business Development Director, Clinical Research Organisation, clinical trials, CRO, MarketingLocation: United KingdomShare: 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: 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: 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

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 Medical Writing Director.   The Medical Writing Director will function as a Lead Medical Writer for a variety of regulatory writing deliverables; and will prepare assigned documents in accordance with the internal/client SOPs and health authority requirements as per the agreed timelines. This individual will conduct a senior review of medical writing deliverables (CSR, IBs, Protocols, etc.), negotiate timelines, and discuss and resolve clients' comments. This role will provide written and verbal feedback to the internal team and clients when appropriate. She/he will keep abreast of current medical writing and regulatory knowledge, including Good Clinical Practice (GCP)/AMWA/EMWA along with developments and advances in clinical drug development. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Takes a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating, and adhering to timelines, organizing document reviews, and communicating directly with the clients.Plans and organizes workload for assigned projects and tasks: identifies project needs, tracks timelines, and implements clients' requests.Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.Presents on Medical Writing processes at full-service bid defense meetings.Develops and delivers training to the global team in various aspects of medical writing.Facilitates project budgeting activities for the medical writing scope by collaborating with the BD team.Creates and maintains standard operating procedures and work instructions to prepare and maintain compliant medical writing deliverables.Oversight of a portfolio of clients.Liaison with assigned clients throughout the lifecycle of a project or program of projects to establish requirements and processes, monitor quality, and capitalize on business development opportunities.Provides scientific and technical guidance to the client and Medical Writers.Provides medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.Keeps Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations.Serves as the primary client contact and Medical Writing representative on assigned project teams, providing support to the Project for developing efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Education and Experience:At minimum a Bachelor's degree or equivalent in medical-related field or life science. Post-graduate degree preferred.At least 10 years of experience as a clinical/regulatory Medical Writer with good clinical/scientific writing skills.Experience working on end-to-end CSR, IBs, and Protocols across different TAs is mandatory. Experience in DSUR will be considered an added advantage.An understanding of the drug development process.Broad experience managing the medical writing responsibilities associated with multiple studies at various stages.Experience in interacting with cross-functional study team members. Specific Role Requirements and Skills:Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and medical writing standards.Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; be attentive to details.Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within an agreed client and regulatory timelines; monitored and communicated progress against milestones; escalate complex issues appropriately.Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.Read, write, and speak fluent English, excellent verbal, and written communication skills.Able to assimilate and summarize large volumes of scientific data accurately, clearly, and concisely.Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat, and Outlook.Be able to juggle multiple priorities and adapt quickly to new situations and new project demands.Culturally aware and able to work comfortably within a global 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: Medical Writing Director, Director of Medical Writing, Director Medical Writer, Director Medical Writing, Clinical Trials, CEP, CER, PMSR, PSUR, SOPs, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated, Clinical Evaluation Reports, medical writing, clinical study, pharmacology, clinical writing.Skills: Medical Writer, CER, clinical trials, CRO, Outsourcing, PharmacologyLocation: GermanyShare: 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 Medical Writing Director.   The Medical Writing Director will function as a Lead Medical Writer for a variety of regulatory writing deliverables; and will prepare assigned documents in accordance with the internal/client SOPs and health authority requirements as per the agreed timelines. This individual will conduct a senior review of medical writing deliverables (CSR, IBs, Protocols, etc.), negotiate timelines, and discuss and resolve clients' comments. This role will provide written and verbal feedback to the internal team and clients when appropriate. She/he will keep abreast of current medical writing and regulatory knowledge, including Good Clinical Practice (GCP)/AMWA/EMWA along with developments and advances in clinical drug development. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Takes a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating, and adhering to timelines, organizing document reviews, and communicating directly with the clients.Plans and organizes workload for assigned projects and tasks: identifies project needs, tracks timelines, and implements clients' requests.Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.Presents on Medical Writing processes at full-service bid defense meetings.Develops and delivers training to the global team in various aspects of medical writing.Facilitates project budgeting activities for the medical writing scope by collaborating with the BD team.Creates and maintains standard operating procedures and work instructions to prepare and maintain compliant medical writing deliverables.Oversight of a portfolio of clients.Liaison with assigned clients throughout the lifecycle of a project or program of projects to establish requirements and processes, monitor quality, and capitalize on business development opportunities.Provides scientific and technical guidance to the client and Medical Writers.Provides medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.Keeps Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations.Serves as the primary client contact and Medical Writing representative on assigned project teams, providing support to the Project for developing efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Education and Experience:At minimum a Bachelor's degree or equivalent in medical-related field or life science. Post-graduate degree preferred.At least 10 years of experience as a clinical/regulatory Medical Writer with good clinical/scientific writing skills.Experience working on end-to-end CSR, IBs, and Protocols across different TAs is mandatory. Experience in DSUR will be considered an added advantage.An understanding of the drug development process.Broad experience managing the medical writing responsibilities associated with multiple studies at various stages.Experience in interacting with cross-functional study team members. Specific Role Requirements and Skills:Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and medical writing standards.Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; be attentive to details.Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within an agreed client and regulatory timelines; monitored and communicated progress against milestones; escalate complex issues appropriately.Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.Read, write, and speak fluent English, excellent verbal, and written communication skills.Able to assimilate and summarize large volumes of scientific data accurately, clearly, and concisely.Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat, and Outlook.Be able to juggle multiple priorities and adapt quickly to new situations and new project demands.Culturally aware and able to work comfortably within a global 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: Medical Writing Director, Director of Medical Writing, Director Medical Writer, Director Medical Writing, Clinical Trials, CEP, CER, PMSR, PSUR, SOPs, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated, Clinical Evaluation Reports, medical writing, clinical study, pharmacology, clinical writingSkills: Medical Writer, CER, CRO, Medical Writing, Outsourcing, PharmacologyLocation: PolandShare: LinkedIn Facebook Twitter Email

As the Account Director, you will play a pivotal role in driving revenue growth from existing relationships with a key Government clients. Your primary responsibility will be building on already fruitful relationships in order to ensure the company's revenue objectives are met and exceeded year on year. You will be responsible executing strategic plans to identify and secure new business opportunities, build strong relationships with key stakeholders, and drive revenue generation. This role requires a dynamic and results-driven individual with exceptional commercial acumen and a proven track record in business development and account management.Your responsibilities will include:Client Relationship ManagementBuild and maintain a strong relationship with a major existing client, understand their business needs and objectives.Serve as the primary point of contact for the client, ensuring maximum satisfaction and that any/all concerns are addressed promptly.Revenue GrowthDevelop and implement strategies to up-sell and cross-sell services.Identify new revenue opportunities withing the client account and collaborate with the sales team to close deals.Be responsible for meeting/exceeding new revenue quotas as set out by the Head of Sales.Strategic Account PlanningConduct thorough account assessments to understand client the client's goals, challenges, and growth opportunities.Develop and implement strategic account plans to maximise revenue potential.Sales LeadershipCollaborate with the sales team to identify and pursue new business opportunities.Lead sales presentations, negotiations, and the overall sales process.Forecasting and ReportingAnalyse sales data and market trends to forecast revenue and identify areas of improvement.Prepare regular reports for management, detailing sales performance, client feedback, and revenue projections.Cross-Functional CollaborationWork closely with other departments, including marketing, product development, event delivery teams, and customer support, to ensure a unified approach to meeting the client's needs and revenue goals.Contract ManagementNegotiate and finalise contracts, ensuring favourable terms for both the client and the company.Collaborate with legal and finance teams to ensure compliance and risk mitigation.The successful Account Director applicant will have the following:* Proven experience in business development or revenue generating account management roles, preferably within the communications industry (ability to sell a service).* Experience of selling into the Government sector, with a good understanding of Government frameworks.* Exceptional communication, negotiation, and relationship-building abilities.* Demonstrated success in driving revenue growth and securing new business opportunities.* Strategic thinker with a data-driven and results-oriented approach to decision-making.* Excellent organisational and time management skills, with the ability to prioritise and manage multiple initiatives simultaneously.* A positive thinker, you are the kind of individual who constantly challenges yourself to exceed expectations and is not easily deterred from achieving goals.* Experience in successful strategic planning, execution and the ability to accurately forecast revenue.* Strong verbal and written communication skills and excellent in delivering presentations.* Proven track record in winning new business and maintaining relationships.* Improving relationships with both internal and external stakeholders.* Leads seeking out/developing new or current business relationships.* Lead any client RFP/QBR/ABR process.* Excellent interpersonal & administration skills.* Excellent processing & time management skills.* Proficient in Microsoft Excel, Word & PowerPoint.* Driving success via using initiative, determination & persistence.* Previous working knowledge of a CRM system (ideally Salesforce).

Lead the Medical department, ensuring alignment with corporate goals and objectives.Develop and implement strategic initiatives that drive growth within the medical affairs sphere.Manage a team of dedicated professionals, fostering an environment of collaboration and excellence.Engage with key stakeholders and attend EU launch team meetings.Ensure compliance with industry regulations and standards.Oversee the planning and execution of scientific events and conferences.Collaborate with cross-functional teams to enhance product development and patient care.Contribute to business development efforts by providing expert advice and insights. A successful 'Director of Medical Affairs' should have:Registered Pharmacist or Qualified Physician.Proven leadership experience within a medical affairs department and previous line management of MSL.Experience launching new products and building and managing MSL teams.Final Medical Signatory experience.Exceptional communication skills, with an ability to engage and influence stakeholders at all levels and be part of product launch team meetings.Demonstrable experience in strategic planning and implementation.A strong commitment to improving patient outcomes.Commercially minded and charismatic, willing to take initiative and drive the strategy for UK product launch.Knowledge of neurology / psychiatry / movement disorders is highly desirable

Geotechncial Associate DirectorLocation - London / South East Salary - Depending on Experience   About Us May Walters is a boutique search consultancy specialising in senior positions within the engineering and environmental sector. The OpportunityOut client is a well estabished mid tiered engineering lead consultancy with offices throughout the UK.  They are privately owned with a national and international network of offices and clients.  In the UK they have a track record in delivering projects in infrastructure, transport and development and have had recent success in recent framework bids, which has lead to a need to increase their delivery capability.The geotechnical division is established in the UK, however there is a need to acquire a team lead in the south east for the London office.  Expressions of interest are sought from indivuals who are interested in developing and leading the office in this discipline. Applications are encouraged by seasoned consultants or individuals who have the right approach and are enthusisatic to make their mark in the industry.  A knowledge of geotechical engineering / enginering geology or geo-environmental backgrounds with a design bias would be desirable and in return a competitive package would be offered for the right individual alongside a friendly and informal working environmentFeel free to contact Martin Higgins in confidence for further information;[email protected] or 0121 5828863 

EIA Assocaite DirectorLocation - UKSalary - Depending on Experience / Competitive About May WaltersMay Walters is a boutique search consultancy specialising in senior positions within the environmental sector. The OpportunityOur longstanding client is one of the fastest growing environmental lead consultancies in the UK, both in terms of organic and acquisitive growth.  They have a varied client footprint across most sectors and have a reputation for delivery within complex mid-sized projects rather than chasing large framework business.  As a larger mid teired consultancy, they are in a good strategic position to be able to gain value value from mid sized projects but also have the gravitas and resource to be successful in bdding on larger projects.  The organisaton, however is maintaining its flat, collaborating structure, as opposed to heirarchical manner and has an employee welfare focus. Expressions of interest are welcome for an Associate Director role, supporting the EIA Lead and helping to grow the EIA team in conjuction with other services lines including ecology, natural capital and ESG.  The existing team is located across a number of offices in the UK, and this role could be based from anywhere in the UK, but preferentiually would be in one of the major city hubs.  Applications will be considered from seasoned consultants or those with less experience who have the right approach and are keen to make their mark in the industry. The role would incorporate team development and mentoring and creating the strategy for engagement with some newly formed and leading edge service lines.  An attractive benefits package will be constructed for the right individual. Feel free to contact Martin Higgins in confidence for further information;[email protected] or 0121 582 8863

Formulate the financial strategy of the School alongside Governors and the Executive Leadership Team (consisting of the two Heads and the Bursar).Attend meetings of the Finance and Risk Committee of the Board of Governors, preparing financial reports and papers and leading on financial items tabled for discussion or decision.Attend and contribute to ad-hoc Governor meetings and discussions as required.Alongside the Bursar and the Heads, implement the School's strategic financial plans.Work closely with ELT to formulate operational spending plans and priorities.Work closely with the Director of HR on people strategies.Exhibit the behaviours and standards befitting a senior leader of St George's Weybridge, demonstrating and promoting the School's ethos and values.Lead and manage the staff in the Finance Department.Bring financial risks and opportunities to the attention of the Bursar and Governors.Conduct modelling and feasibility studies as appropriate.Review and implement changes to the system of financial control and reporting.Oversee production of monthly management information and bring appropriate matters to the attention of the Bursar, Heads and budget holders.Prepare papers for, attend, and contribute to the dealings of the Finance and Risk Committee.Prepare financial appraisals and reviews of major projects.Prepare long term forecasts and sensitivity analysis.Undertake competitor analysis and benchmarking studies.Retain financial awareness of external changes and development and provide recommendations and advice to the Bursar, including a thorough knowledge of relevant accounting requirements, such as GAAPs, FRSs and the Charity Commission SORP.Proactively investigate and promote ways of improving value for money.All accounting functions including nominal, purchase and fee ledgers, fixed asset register and the payroll.Oversee the staff and systems delivering all aspects of payroll.The accurate and timely production of management and financial accounts.The internal control environment.Management and control of fee collection.Preparation of the consolidated statutory accounts for St George's Weybridge and subsidiary companies.Liaising with external auditors on all matters connected with the annual audit of the School's accounts and other external accountancy advice.Preparing annual budgets and termly forecasts, including cash flow projections for the current and future years.Maintain, review and ensure compliance with the School's Financial Procedures Manual.Preparation of internal financial management reports, accounts and briefing papers, including monthly management accounting information to include cash flow statements and forecasts.Control of the treasury management function in order to ensure the most efficient and secure deployment of cash.Ensuring compliance with external regulators, including HMRC, the Charity Commission and Companies House.Being responsible for accurate and timely tax returns and tax reclaims, with professional advice where necessary, preparing recommendations for mitigating potential VAT and any other tax liabilities.Formal Accounting qualification and experience of working in the commercial, educational or charity sectors.Experience of compliance with legislation and regulations relevant to the positionExperience of contract negotiationExcellent communication skills, both oral and written.Ability to analyse and manipulate financial data.Competent in the use of IT, notably MS Office applications and the ability to use modern financial software tools.Proven experience of managing a team within a complex organisationEmpathy with the ethos and values of St George's Weybridge.Personal warmth, tenacity and a transparent collaboration style.A 'can-do' attitude with a sense of humour and proportion.A flexible approach to work, both in terms of responding to changing or unforeseen circumstances and being willing to work outside of regular hours as the need arises

Requisition ID 34190 Office Country United Kingdom Office City London Division Sweden/Iceland/Estonia Contract Type Regular Contract Length Posting End Date 12/01/2024 Role Overview The Board of Directors is divided into 23 Constituency Offices, representing the Bank's 74 shareholders. Each office typically has a Director, an Alternate Director and an Executive Assistant, although some offices may also have one or more Advisers. The Executive Assistant reports to the Director, but is also expected to provide administrative and secretarial support to the Alternate Director, as well as ensuring the smooth running of the Constituency Office. In addition, the Executive Assistant may be required to assist with more specialised tasks involving contact with government officials and other Constituency nationals. Accountabilities and Responsibilities To provide administrative and secretarial support to the Director and Alternate Director, and ensure the smooth running of the Constituency Office. Responsible for the orderly conduct of routine administrative business of the office. Efficient diary management; arranging internal and external meetings; dealing with visitors. Making travel arrangements and hotel reservations; arranging visas as and when required. Dealing with expense records for Constituency budget purposes and handling appropriate claims relating to travel, hospitality and medical matters. Typing reports, correspondence and memoranda. Photocopying. Drafting routine business correspondence as required. Distributing Board documents and other materials within the office and capitals. Monitoring communications with capitals and ensuring Constituency requirements are being looked after. Monitoring office budget. Deal with the necessary preparations for Annual Meetings and other major events. Maintaining an effective filing system. Other ad-hoc administrative and secretarial duties as required. Knowledge, Skills, Experience & Qualifications Proven secretarial / administrative experience and sound knowledge of the EBRD, with an excellent performance record. Knowledge of the Bank’s procedures and policies. Fluent English, both written and spoken. Knowledge of Swedish, Icelandic or Estonian, both written and spoken, desirable but not essential. Excellent organisational skills and ability to work on own initiative. Good typing skills (55 wpm). Computer literate: Microsoft Outlook, Word, Excel, PowerPoint, Teams and SAP. Excellent communication skills, both written and spoken. Experience and knowledge in dealing with other institutions and the business community. Diplomatic skills and protocol experience to handle relations with authorities, business community and EBRD staff in a multicultural setting. Ability to adapt to change and respond positively to new challenges. Competencies & Personal Attributes Enthusiastic and self-motivated. Strong team player, able to integrate into a small team with the ability to work efficiently and effectively handling simultaneous assignments on a wide variety of tasks involving a wide range of internal and external contacts. Ability to cope well under pressure and a capacity for hard work. Good sense of priorities and initiative. Reliable, flexible and willing to work overtime if required. What is it like to work at the EBRD? Our agile and innovative approach is what makes life at the EBRD a unique experience! You will be part of a pioneering and diverse international organisation, and use your talents to make a real difference to people's lives and help shape the future of the regions we invest in. The EBRD environment provides you with: Varied, stimulating and engaging work that gives you an opportunity to interact with a wide range of experts in the financial, political, public and private sectors across the regions we invest in; A working culture that embraces inclusion and celebrates diversity; An environment that places sustainability, equality and digital transformation at the heart of what we do. Diversity is one of the Bank’s core values which are at the heart of everything it does. A diverse workforce with the right knowledge and skills enables connection with our clients, brings pioneering ideas, energy and innovation. The EBRD staff is characterised by its rich diversity of nationalities, cultures and opinions and we aim to sustain and build on this strength. As such, the EBRD seeks to ensure that everyone is treated with respect and given equal opportunities and works in an inclusive environment. The EBRD encourages all qualified candidates who are nationals of the EBRD member countries to apply regardless of their racial, ethnic, religious and cultural background, gender, sexual orientation or disabilities. As an inclusive employer, we promote flexible working and expecting our employee to attend the office 50% of their working time. Job Segment: Administrative Assistant, Executive Assistant, Secretary, Sustainability, Banking, Administrative, Energy, Finance