Planet Pharma
, MA, United States, MA, USA
**Candidates can only be considered if they are currently located in Eastern Time Zone **Must have Module 2 experience Planet Pharma's client is looking for an Associate Director / Senior Medical Writer, who will be responsible for providing medical writing support for the development of complex clinical documents for regulatory submissions including, but not limited to clinical protocols, informed consents (ICFs), clinical study reports (CSRs), investigator brochures (IBs), patient narratives, annual reports and other key clinical and regulatory documents. This individual will support the overall strategy for all medical writing processes according standards. Key Accountabilities/Responsibilities: Manage medical writers (in-house FTEs and contractors, and external vendors) who are individually contributing to the MW activities for a variety of regulatory documents Author clinical content and project manage SME contribution of regulatory documents to develop...
