Clinical stage biotechnology pharmaceutical company looking for an experienced Sr. Manager of Medical & Scientific Writing to manage junior writers and be a lead author for Protocols, Clinical Study Reports, Investigator Brochure’s, INDs, CTD summary documents, and others.
Plan for the writing and management of protocols, CSRs, IBs, health authority meeting briefing packages, Common Technical Document (CTD summaries, response to regulatory questions, INDs, etc.
Manages and oversees contract medical writers and medical writing vendors
Reviews and ensures the quality of documents prepared by internal or contract medical writers
Provides expertise on regulatory requirements and ensures assigned documents are produced in accordance with such guidance and relevant internal standard operating procedures
Master’s degree in related field, scientific PhD degree highly preferred
6 years of relevant and progressive experience
Experience with writing documents in support of an NDA
Recent experience writing regulatory documents such as CSRs, protocols, CTD summaries and overviews
Experience in Phase I-III Clinical trial documents