Bill Gembala
Senior Director Medical Writing, Therapeutic Area Lead Oncology at Pfizer
- Role
- Senior Director Medical Writing (Therapeutic Area Lead Oncology) at Pfizer
- Location
- Seattle, WA, US
- LinkedIn followers
- 500 followers
About Bill Gembala
Team-oriented Medical Writer and Biomedical Communications Expert with 25+ years of experience in the biopharmaceutical/healthcare field. Extensive experience in scientific publications, medical publishing and publication planning. Proficient in the preparation and review of clinical study reports, clinical protocols, peer-reviewed publications and juried convention abstracts/posters. Expert corporate/business intelligence researcher. Masters Degree in Library and Information Science, with over 15 years of experience as a medical/corporate biopharmaceutical librarian.
Experience
Senior Director Medical Writing (Therapeutic Area Lead Oncology)
Dec 2023 — Present · Bothell, WA, US
Responsible for providing strategic, scientific, and operational expertise to drive the planning and preparation of documents pertaining to clinical studies and regulatory interactions, including (but not limited to) protocols, clinical study reports, briefing documents, clinical summaries for marketing applications, and responses to queries from regulatory authorities. Has responsibility for deliverables for one or more therapeutic area and establishes asset- and therapeutic area-level strategies.* Manages and trains internal staff to support delivery of high-quality deliverables and contributes to the development of roles in the group to enhance/expand Medical Writing support models.* Oversees external vendor staff and demonstrates in-depth knowledge of forecasting, budgeting, and vendor oversight processes.* Is a subject matter expert in clinical regulatory writing and has advanced knowledge of other functional areas who can lead internal cross-functional initiatives, represent the Medical Writing group on internal governance committees, and represent Pfizer in external industry collaborations.
Education
University of Washington
MLibr, Library and Information Science
1994 — 1996
University of Washington
BA
1992 — 1994
Skills
- Clinical Trials
- Clinical Research
- Gcp
- Biotechnology
- Oncology
- Pharmaceutical Industry
- Publishing
- Regulatory Affairs
- Fda
- Clinical Development
- Lifesciences
- Medical Writing
- Regulatory Submissions
- Biopharmaceuticals
- Sop
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