Director, Scientific Writing
$164,981–$210,651 year
On-siteGaithersburg, Maryland, United States
Job Summary
Lead the development of protocols and study reports for global and US Oncology medical affairs clinical interventional studies from Phase II through IV. Personally author and oversee scientific writing outputs including abstracts, manuscripts, and HTA dossier summaries for real-world evidence and observational studies. Drive the AI adoption roadmap by evaluating, piloting, and scaling AI-assisted drafting and literature synthesis tools while establishing governance frameworks for responsible use. Manage budgets, contractor relationships, and performance of internal and external scientific writers to deliver high-quality outputs across interventional trials and registry analyses.
Required Qualifications
- Advanced degree in a scientific or medical field (eg PharmD, PhD, MD)
- At least 7 years experience in scientific writing
- Demonstrated experience in the publications field, or medical communications gained through working in the pharmaceutical industry or a medical communications agency
- Broad understanding of drug development process
- Hands-on proficiency with AI writing tools (e.g. Claude, Copilot, Gemini) and demonstrated ability to critically evaluate outputs for scientific accuracy, regulatory alignment, and compliance with GPP/ICMJE standards; understanding of where AI can and cannot be applied in regulated medical writing contexts
- Demonstrated performance, budget, and resource management skills in a global organization
- Be independent, organized, and able to act as a leader in a fast-paced environment
- Ensure strict adherence to company policies, industry regulations, and ethical standards in all publications
- Flexibility and adaptability to lead long-term activities in a constantly changing internal and external environment
- Validated experience crafting and scaling AI-enabled workflows (e.g. ptimelylibraries, automated literature review, structured output templates), with measurable impact on timelines, throughput, or quality; comfort operating in a regulatory environment where AI use must be disclosed, validated, and defensible
Desired Qualifications
- Desirable Therapeutic knowledge in oncology
- Certification as a Medical Publication Professional (CMPP) desired
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