Senior Medical Writing Manager will be responsible for writing, reviewing, and preparing clinical and regulatory documents including protocols/amendments, investigator brochures, consent forms, regulatory briefings, DSURs, final study reports, sections of INDs, and NDAs.
Drive document management from start to finish (ie, generation of a blank document to a final approved version), which may include, but is not limited to: first draft authoring, reference retrieval, generating bibliographies, editing (eg, follow house style guide), and managing various processes
Develop high-quality documents that meet domestic and international regulatory submission standards.
Coordinate and manage consulting writers as needed.
Review and prepare protocols/amendments, investigator brochures, consent forms, regulatory briefings, DSURs, final study reports, sections of INDs, and NDAs.
At least 5+ years’ experience in Medical Writing biotech/pharma required.
Prior experience writing Clinical Study Reports, Investigator Brochures, Protocols.
Prior experience crafting and compiling documents for inclusion in/support of milestone regulatory submissions (IND, NDA, MAA, etc.).