Michelle Swotinsky
Senior Director, Medical Writing at Alexion Pharmaceuticals
- Role
- Senior Director, Medical Writing at Alexion Pharmaceuticals, Inc.
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Michelle Swotinsky
Regulatory medical writing professional with 15+ years of pharmaceutical/biotechnology industry experience. Expertise in writing standard operating procedures (SOPs), study protocols, protocol amendments, investigator brochures (IBs), clinical study reports (CSRs), patient narratives, development safety update reports (DSURs), new drug application (NDA) summary documents, and briefing books. Therapeutic areas of experience include central nervous system (CNS), oncology, and cardiovascular. Detail-oriented with strong medical writing skills and experience in growing, managing, and developing regulatory medical writing groups and demonstrated ability to work effectively and cooperatively across functional groups.
Experience
Senior Director, Medical Writing
Apr 2021 — Present
Education
UCLA
Master of Public Health (MPH), Epidemiology
UCLA
Master of Science (MS), Microbiology and Immunology
University of Virginia
BA, Biology
Skills
- Regulatory Submissions
- Life Sciences
- Clinical Development
- Ctms
- U.s. Food and Drug Administration (Fda)
- Medicine
- Oncology
- Medical Writing
- Biotechnology
- CRO Management
- Ind
- CRO
- Pharmaceutical Industry
- Fda
- Clinical Trials
- Drug Development
- Gcp
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