Manager, Product Development CMC Writer Putney
THIS JOB HAS EXPIRED Description
Putney is a pharmaceutical company based in Portland, ME which specializes in providing high quality generic drugs for pets. Putney is a virtually integrated organization that uses CRO?s, CMO?s and partnerships around the world to develop a wide range of dosage forms for the veterinary market. The position of Manager, Product Development CMC Writer provides a unique opportunity to play a crucial role in optimizing the development and commercialization activities of Putney?s rapidly growing product pipeline.
The CMC Writer will be a member of the Product Development team and report to the Senior Director, Product Development. The CMC writer will develop overall document strategy with Regulatory and CMC leaders and then execute document creation, collation, editing and review. The CMC Writer will work closely with Product Development CMC technical experts, Regulatory and Quality to ensure consistency, accuracy and flow of message in CTD/question based review (QbR) sections that Regulatory will submit to FDA-CVM to support new ANADAs, and supplements and amendments to existing applications.
The ideal candidate must have a degree in life sciences combined with experience in CMC technical writing (preparation of CMC/regulatory documentation with significant independence). A working knowledge of cGMPs and CTD format, excellent verbal and written communication skills, and collaboration skills with focus on timely delivery are critical. He/she should have 5+ years in the pharmaceutical industry with experience in product development and manufacturing. Project management skills and experience are valuable. Significant experience in Microsoft office, Adobe and SharePoint is required.
||Portland, ME |
THIS JOB HAS EXPIRED