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Associate Director- Medical Affairs, Publication Mgmt

Regeneron
Full-time
On-site
Sleepy Hollow, NY
Medical Affairs

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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
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