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Associate Director- Medical Affairs, Publication Mgmt

Regeneron
On-site
Sleepy Hollow, NY
Medical Affairs

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
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