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Role Summary
Associate Director, Medical Affairs, Publication Mgmt role focused on strategic development, management and dissemination of Global publication plans across therapeutic areas, including clinical, HEOR/RWE, PKPD, and disease state publications. Lead cross-functional publication teams to develop, manage, and implement publication plans; participate in cross-functional meetings and strategic reviews to align partners.
Responsibilities
- Partner in the development of scientific, clinical, and health-outcomes publications ensuring accuracy and readability and timely development
- Ensure publications are aligned with scientific narrative, strategy, and interpretation of statistical analyses
- Lead cross-functional and alliance-wide publication teams
- Liaise with alliance partners
- Budget, forecasting, and resource allocation planning; develop materials to track expenditures and issues
- Contribute to cross-functional discussions to identify gaps and opportunities to evolve the publication plan
- Manage processes and activities focusing on quality and timeliness
- Accurate and timely reporting of post-publications metrics; maintain records in Publication Management Tool, vendor, and budget management
- Collaborate to review and submit clinical manuscripts, abstracts, scientific meeting presentations, and digital enhancements; ensure alignment with CIFs
- Adhere to policies and maintain knowledge of industry compliance guidance and regulations
- Ensure version management and proper documentation practices
- Develop and maintain knowledge on products, therapeutic areas, pipeline products, and competitive products
Qualifications
- MS or PharmD or PhD required
- Excellent knowledge of Good Publication Practices, ICMJE guidelines, CONSORT, Sunshine Act
- 6+ years in medical communications or publications management or related medical affairs industry experience
- 2–3 years leading cross-functional publication plans and teams
- Pharmaceutical industry experience required; medical communication agency experience a plus
- Strong writing and editing skills; proficiency with publication management systems (e.g., iEnvision)
- Knowledge of GPP 22, ICMJE, OIG, PhRMA code, Sunshine Act; ability to collaborate with multidisciplinary teams
- Ability to lead therapy area discussions and explain scientific concepts to all levels
Skills
- Strategic publication planning and leadership
- Cross-functional collaboration and alliance management
- Scientific writing and editing
- Budgeting and project management
- Regulatory and compliance acumen
- Communication and relationship-building with medical/scientific experts
Education
- MS or PharmD or PhD required
Additional Requirements
- On-site requirement: Sleepy Hollow, NY office; 4+ days/week on-site; relocation benefits available; no hybrid/remote option