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.
This position is located at our Warren, NJ or Sleepy Hollow, NY office with a requirement to be on-site 4 days/week. If eligible, we can offer relocation benefits. We cannot offer a hybrid or fully remote option.
A typical day may include the following:
• 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.
This may be for you if you:
• Are adaptable to independently leading publication plans strategically and effectively in a fast paced, growing environment.
• Outstanding work ethic and integrity, including high ethical and scientific standards
• Strong interpersonal skills particularly motivational, negotiation, listening, judgment, analytic, and conflict management skills, demonstrated by leading to consensus
• Ability to cultivate and maintain relationships with leading medical/scientific experts.
To be considered you are to have 10+ years in medical communications, publications management or related experience in medical affairs, of which 3+ years must have been spent in independently leading cross-functional publication teams. Experience must be 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.
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Director Medical Affairs Publications • Warren