Role Summary
Associate Director, Medical Affairs (Scientific Communications/Publications) supports the Clinical/Medical/Regulatory team in the efficient planning, preparation, and data dissemination at conferences and in journal publications. The role requires a strong background in scientific writing, scientific conference management, publication planning, and project management within biotech or pharmaceutical settings. This role can be remote (East Coast hours) or based at the Philadelphia, PA headquarters.
Responsibilities
- Manage the end-to-end process of publication planning, ensuring adherence to timelines and compliance with industry standards.
- Collaborate with cross-functional teams, including Clinical Development, Translational Medicine, Computational Biology, Regulatory Affairs, and external authors/key opinion leaders, and vendors, to facilitate the development of manuscripts, abstracts, posters, and presentations.
- Manage the operational execution and day-to-day budget for external medical writing and communications agencies that support content and publication deliverables.
- Lead the preparation of journal manuscripts and abstracts and presentations for medical conferences, ensuring compliance with conference guidelines and requirements.
- Advise teams regarding compliance with medical publications as defined in journal and congress guidelines.
- Coordinate internal review processes and facilitate approval workflows for publications in collaboration with Legal, Compliance, and Medical teams.
- Train internal teams on publications software and workflows.
- Assist in the preparation of scientific content for medical conferences and other scientific forums.
- Maintain awareness of industry trends and regulatory guidelines related to publication practices in the biopharmaceutical industry.
- Develop and execute comprehensive scientific engagement strategies and congress plans (e.g., manage relationships with conference organizers, lead internal pre/post congress meetings, organize onsite HCP meetings).
- Conduct literature searches and maintain databases of scientific publications relevant to cell therapy and related therapeutic areas.
- Assist in the development and execution of medical affairs activities including advisory boards, internal trainings, patient advocacy group engagements, etc.
- Partner with cross-functional teams to create integrated evidence generation plans.
Qualifications
- Masterβs degree in Health Care, Life Sciences, Biomedical Sciences, or a related field.
- Preferred: Terminal degree in Life Sciences or healthcare (PharmD, PhD, MD, etc.).
- 3+ years of experience in medical affairs, scientific communications, or publication planning within the biotechnology or pharmaceutical industry.
- Therapy area experience in rheumatology, neurology, immunology, and/or cell therapy.
- Experience working with publications management software/vendors (such as iEnvision, PubStrat, PubPro).
- Experience managing a publications or asset/project budget including overseeing external vendors.
- Strong scientific writing skills with the ability to translate complex scientific data into clear and concise publications, including ability to analyze and interpret clinical trial data.
- Knowledge of publication guidelines (e.g., ICMJE, GPP2022) and industry best practices.
- Excellent organizational skills with the ability to manage multiple projects simultaneously and meet deadlines.
- Proficiency in Microsoft 365 (Word, Excel, PowerPoint, OneNote).
- Preferred: CMPP and ISMPP active member.
Skills
- Scientific writing and publication planning
- Conference management and manuscript/abstract preparation
- Cross-functional collaboration with Clinical Development, Translational Medicine, Regulatory Affairs, and external authors
- Project and budget management for external medical writing vendors
- Knowledge of publication guidelines (ICMJE, GPP2022) and industry best practices
- Literature searches and development of medical affairs content
- Publications software and workflows
- Training internal teams on publications software and workflows
- Microsoft 365 proficiency (Word, Excel, PowerPoint, OneNote)
Additional Requirements
- Travel up to 25% to attend conferences and meetings.