Associate Director- Medical Affairs, Publication Mgmt

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.

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

• Required: MS or PharmD or PhD
• Required: Excellent knowledge of and compliance with 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: Experience within the pharmaceutical industry; experience in a medical communication agency is a plus
• 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, and general copyright and permission rules
• Required: Ability to collaborate with a multi-disciplinary team and an alliance of drug development partners; ability to lead therapy area discussions

Skills

• Strategic publication planning
• Cross-functional leadership and collaboration
• Budgeting and resource management
• Scientific writing and editing
• Publication management systems proficiency
• Regulatory and compliance awareness in medical publishing

Education

• MS, PharmD, or PhD