Manager, Medical Affairs – Scientific Review

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Oversee the medical and scientific evaluation of promotional and non-promotional materials for designated products and markets.

• Act as the scientific reviewer and subject matter expert for specific therapeutic areas and products.

• Ensure that data is scientifically accurate, contextually appropriate, editorially precise, scientifically balanced, and compliant.

• Assess the clinical and statistical significance of claims and data.

• Confirm that claims are sufficiently supported by data and evaluate the acceptability of references.

• Advise on the consistency of claims with approved labeling.

• Ensure that materials are pertinent and beneficial for target audiences.

• Collaborate with Medical Affairs, Legal, Regulatory, Commercial, and various cross-functional reviewer and writer teams.

• Engage in Medical, Legal, and Regulatory review committees.

• Review and approve country-specific materials to ensure regulatory and client compliance.

• Contribute to scientific narratives, medical presentations, publications, meeting materials, and medical information content.

• Maintain expertise in therapeutic areas, industry standards, regulatory requirements, publication practices, and review platforms like Veeva.

• Support regulatory submissions of promotional materials and related documentation as needed.

• Assist the Global Medical Information / Medical Content Development Team on client projects.

• Develop project plans in collaboration with project management when necessary.

• Take ownership of client deliverables, ensuring both timeliness and quality.

• Coordinate and engage in client meetings, including setting agendas, tracking action items, and following up.

• Write and develop materials, as well as perform quality assurance on the deliverables of writers and graphic designers.

• Utilize EVERSANA and client document management platforms such as Veeva PromoMats and MedComms as the content owner.

• Attend MLR meetings and cross-functional team meetings when appropriate.

• Show a commitment to diversity, equity, and inclusion.

• Ensure client satisfaction, manage quality concerns, and implement timely corrective and preventive actions.

⛳️ Requirements

• Proven experience in medical writing, regulatory affairs, or related fields.

• Strong understanding of therapeutic areas and regulatory requirements.

• Excellent communication and collaboration skills.

• Ability to assess and interpret scientific data effectively.

• Familiarity with document management platforms and review processes.

• Commitment to maintaining high standards of quality and compliance.

🏝️ Benefits

• Full-time, home-based position.

• Dedication to ongoing professional development and remaining up-to-date with industry trends and regulatory changes.

• Recognized as a Great Place to Work certified employer.

• Focused on diversity, equity, and inclusion in the workplace.

• Equal Opportunity Employer.