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We are seeking a detail-oriented and proactive Associate Director, Medical Affairs to support our Clinical/Medical/Regulatory (CMR) team in the efficient planning, preparation, and data dissemination at conferences and in journal publications. Reporting to the Senior Director, Medical Affairs, the ideal candidate will have a strong background in scientific writing, scientific conference management, publication planning, and project management within the biotechnology or pharmaceutical sectors.
Job Responsibility:
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 (i.e. manage relationships with conference organizers, lead internal pre/post congress meetings, organize onsite HCP meetings, etc.)
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 generations plans
Requirements:
Master’s degree in Health Care, Life Sciences, Biomedical Sciences, or a related field
>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)
Ability to travel up to 25% to attend conferences and meetings
Nice to have:
Terminal degree in Life Sciences or healthcare (PharmD, PhD, MD, etc.)
Certified Medical Publication Professional (CMPP) and ISMPP active member