Associate Director- Medical Affairs, Publication Mgmt

Role Summary

Associate Director, Publications, responsible for 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 and implement publication plans, participate in cross-functional and alliance meetings, and ensure alignment of partners.

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
• Liaise with alliance partners
• Budget, forecasting, and resource allocation plan by developing materials to track team expenditures and potential issues
• 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
• Accurate and timely reporting of post-publications metrics, compliant maintenance of records in the 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 company policies and procedures and maintain a working knowledge of all pertinent industry compliance guidance and regulations
• Ensure version management and proper documentation practices
• Develop and maintain knowledge on our products, relevant therapeutic areas, pipeline products, and competitive products

Qualifications

• MS or PharmD or PhD required
• Excellent knowledge of and compliance with Good Publication Practices, ICMJE guidelines, CONSORT, Sunshine Act
• At least 6 years in medical communications or publications management or related industry experience in medical affairs, including 2-3 years leading cross-functional publication plans and teams
• Experience within the pharmaceutical industry required; experience in a medical communication agency a plus
• Strong writing and editing skills
• Proficiency operating within iEnvision or other publication management systems
• Knowledge of GPP 22, ICMJE, OIG, PhRMA code, Sunshine Act, copyright and permission rules
• Ability to collaborate with a multi-disciplinary team and an alliance of drug development partners
• Ability to lead therapy area discussions to explain scientific/medical concepts to all levels

Skills

• Strategic publication planning
• Cross-functional team leadership
• Scientific writing and editing
• Budgeting and resource management
• Communication and stakeholder management
• Regulatory and compliance knowledge

Education

• MS or PharmD or PhD

Additional Requirements

• On-site work requirement at Sleepy Hollow, NY office (4+ days/week); relocation benefits available for eligible candidates; no hybrid/remote option