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Associate Medical Writing Director, FSP
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$124,400 - $211,900 a year
Full-time
- Keep abreast of current medical and/or technical writing/regulatory knowledge, including Good Clinical Practice (GCP), along with developments and advances in drug development/medical and/or technical writing.
- Writes clear and concise clinical submission documents, including clinical study reports, protocols, clinical overviews, investigator brochures, and summary documents; experience with late-stage health authority responses is a plus.
- Review statistical analysis plans and incorporate into clinical study reports or submission documents, as applicable.
- Drive the document preparation process, manage timelines, receive, and review primary statistical output, draft, and distribute document for review, compile comments and edits, lead comment resolution meetings independently.
- Preferred - Masters or PhD in Life Sciences or related field
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