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Associate Director- Medical Affairs, Publication Mgmt

Regeneron
On-site
Sleepy Hollow, NY
Medical Affairs

Role Summary

As an Associate Director, Publications, you will play a strategic role in the development, management and dissemination of our Global publication plans. This includes the execution of publications including but not limited to clinical, HEOR/RWE, PKPD, and disease state. Responsibilities will include leading cross-functional publication teams to develop, manage, and implement publication plans for our therapeutic areas. You will be expected to participate in cross functional meetings, monthly core publication team meetings, present at regular strategic meetings, workshops and relevant alliance meetings needed to build and refine publication plans ensuring partners are aligned and updated.

This position is located at our Sleepy Hollow, NY office with a requirement to be on-site 4+ days/week. Relocation benefits may be offered. We cannot offer a hybrid or fully remote option.

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 knowledge of 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

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

Skills

  • Cross-functional leadership and collaboration
  • Project management and prioritization
  • Strategic communication
  • Attention to detail

Education

  • MS or PharmD or PhD is required

Additional Requirements

  • On-site work 4+ days/week at Sleepy Hollow, NY
  • Hybrid or remote options are not available