Manager, Medical Affairs and Scientific Review

THE POSITION:

At EVERSANA, we provide end-to-end integrated global medical information and medical affairs services for various life sciences companies, including pharmaceutical, biotechnology, medical device, digital therapeutics, and over-the-counter companies of various sizes, including industry leaders and emerging companies. Additionally, we provided therapeutic area support across oncology, hematology, rare diseases, immunology, cardiology, dermatology, urology, gastroenterology, infectious diseases, nephrology, neurology, pain, rheumatology, respiratory, ophthalmology, endocrinology, pulmonology, hepatology, consumer products, women’s health, and more.

This position is part of our Global Medical Content Development and Medical/Scientific Review team. The role requires strong medical and scientific expertise, a solid understanding of regulatory requirements and the best industry practices for both promotional and non-promotional materials in accordance with European pharmaceutical regulatory requirements, codes, and guidelines, including EMA regulations and guidance, the EFPIA Code, the ABPI Code of Practice, and country-specific regulations governing promotional and non-promotional communications. Candidates must demonstrate exceptional attention to detail, a commitment to medical and scientific accuracy, and the ability to critically analyze, interpret, and translate scientific literature and data into clear, compliant content. The ideal candidate will be able to rapidly develop expertise in new therapeutic areas and possess excellent written and verbal communication skills. This is a full-time, home-based position, and applicants must be legally authorized to work in Europe and hold a valid work permit.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
Our employees are tasked with delivering excellent business results through the efforts of their teams.  These results are achieved by:

MEDICAL REVIEW

• Lead the medical and scientific review of promotional and non-promotional materials for assigned products and markets, ensuring compliance with applicable regulations, industry codes (e.g., EFPIA, ABPI), and internal policies.
• Serve as the scientific reviewer and subject matter expert (SME) for assigned therapeutic areas and products, providing strategic medical input throughout content development and review
• Ensure that data are scientifically accurate, contextually correct, editorially accurate, and are presented in a fair/scientifically balanced manner with minimal supervision and on time:
  • Ensures scientific accuracy, relevance, and completeness of data
  • Ensures claims and data are clinically and statistically relevant and presented in a scientifically balanced manner (not false or misleading)
  • Ensures that claims are adequately supported by data
  • Determines acceptability of references
  • Advises on whether claims are consistent with the approved label
  • Ensures that the piece is relevant and of utility for the target audience.
• Collaborate with Medical Affairs, Legal, Regulatory, Commercial, and cross-functional teams of reviewers and writers to facilitate compliant and effective scientific communications
• Participate in Medical, Legal, and Regulatory (MLR) review committees, providing guidance on scientific substantiation, messaging, and risk mitigation
• Review and approve country-specific materials, ensuring alignment with local and international regulations, guidance documents, and client requirements.
• Contribute to the development and review of key Medical Affairs deliverables, including 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 (e.g., Veeva) to drive continuous quality and compliance
• Support regulatory submissions of promotional materials and associated documentation, where required by local authorities.

MEDICAL CONTENT DEVELOPMENT

• Plays an essential role in supporting the Global Medical Information / Medical Content Development Team on content development-related engagements for clients who require medical content development and management services.  
• Establishing a project plan (in partnership with project management when applicable)
• Accountable for the client deliverables, including timeliness and quality
• Coordinating and participating in meetings with clients, agendas, action items, follow-up
• Responsible for writing and developing materials, in addition to performing quality assurance of assigned writers’ and graphic designers' deliverables
• Works with EVERSANA and/or client-provided document management technology platforms (i.e., Veeva PromoMats / MedComms, etc.) as content owner and attending MLR meetings when appropriate
• If assigned, may attend cross-functional team meetings (e.g., complete commercialization meetings)
• All other duties as assigned

GENERAL

• Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias
• All other duties as assigned.

EXPECTATIONS OF THE JOB:

• Responsible for delivering CLIENT DELIGHT
• Responsible for working collaboratively with the EVERSANA medical information and medical affairs team and taking directions and feedback from management and clients
• Responsible for ensuring management and compliance with industry standards and codes of practice
• Able to work independently to develop high-quality, scientifically accurate, strategically aligned, ethical, and compliant medical content
• Responsible for proactively flagging and managing any quality issues, and ensuring timely corrective and preventive actions
• Hours: Able to work full time and be flexible with work scheduling as required by clients and management