Director, Medical Affairs Publications

Role Summary

As a Director, Medical Affairs Publications you will play a strategic role providing expertise for development, management and dissemination of our aligned global publication plans supporting Oncology and Hematology. This will include the execution of clinical, HEOR/RWE, PKPD, and disease state publications. Responsibilities include leading cross-functional publication teams to develop, manage, and implement publication plans for our therapeutic areas.

Responsibilities

• Partner in the development of scientific, clinical, and health-outcomes publications ensuring accuracy and readability of content and timely development
• Ensure publications are aligned with scientific narrative and lexicon and strategy, including key strategic communication points and interpretation of statistical analyses
• Leadership of cross-functional and alliance wide publication teams
• Manage budget, forecasting, and resource allocation plan by developing materials to track team expenditures
• Contribute to the development and facilitate cross-functional discussions to identify gaps and opportunities to evolve the publication plan
• Manage processes, and activities focusing on quality and timeliness with an eye for efficiency
• Accurate and timely reporting of post-publications metrics, compliant maintenance of records in the Publication Management Tool (e.g., iEnvision), vendor and budget management
• Collaborate to review and submit clinical manuscripts, abstracts, scientific meeting presentations and digital enhancements; ensure alignment with CIFs
• Adhere to company policies and procedures and maintain a working knowledge of all pertinent industry compliance guidance and regulations including GPP 2022, Sunshine Act, ICMJE guidelines, OIG, PhRMA code
• Ensure version management and proper documentation practices
• Develop and maintain expertise with Regeneron products, relevant therapeutic areas, pipeline products, and competitive products

Qualifications

• 10+ years in medical communications, publications management or related experience in medical affairs, including 3+ years leading cross-functional publication teams
• Experience from a pharmaceutical company; experience in a medical communication agency is helpful
• A PharmD or PhD or Master’s degree in a life sciences is required
• Ability to lead therapy area discussions to explain scientific/medical concepts to all levels
• Proficiency operating within iEnvision or other publication management systems

Education

• PharmD or PhD or Master’s degree in a life sciences field

Skills

• Strong leadership and cross-functional collaboration
• Strategic publication planning and execution
• Budget management and resource forecasting
• Regulatory and compliance knowledge (GPP 2022, Sunshine Act, ICMJE, OIG, PhRMA code)
• Publication management systems proficiency (e.g., iEnvision)
• Scientific communication and ability to translate data into publications