The Principal Medical Writer is an individual expert contributor capable of independently executing complex writing assignments involving a thorough understanding of clinical trial designs and interpretation of statistically analyzed research data.
He/she would be expected to drive and coordinate the process to draft, review and approve written assignments including marketing application submission documents.
He/she has the ability to plan and prioritize without supervision.
This role requires extensive clinical document expertise and will support continuous improvement and the implementation of best practices.
Key Responsibilities:
Proven track record in writing clinical regulatory documents including, but not limited to: protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
Work in a matrix team to ensure delivery of high quality, fit-for-purpo...