Job Title:
Senior/Principal Medical Writer
Full time, Tarrytown, NY
Job Description:
The Principal Medical Writer will be responsible for ensuring adherence to department guidelines, templates, SOPs, and regulatory guidelines for all Medical Writing documents provided for their therapeutic area. The individual in this position will work independently writing CSRs, CSPs, CSP amendments, IBs and IB updates, and Clinical Summaries in a variety of therapeutic areas. This positions focuses mainly on protocol writing. Work closely with Medical Directors, Biostatisticians and/or regulatory liaisons to develop high quality clinical documents.
Responsibilities:
Working with the clinical team, the Principal Medical Writer will be responsible for writing following documents:
- Clinical Study Protocols
- Clinical Study Protocol Amendments
- Clinical Study Reports
- Investigator brochures
- Clinical Summaries
- Other documents, as needed
Required Skills:
- Have written CSRs, clinical protocols, clinical protocol amendments, IBs, IB updates and clinical summaries for NDA/BLA/MAA, etc.
- Understand the general document content for each clinical document type, how the individual document types fit into a filing and feed from one to the next, and how to message appropriately across the clinical documents in a filing.
- Experience writing clinical protocols and protocol amendments.
- Expected to resolve issues and escalate problems, as necessary
- Contribute to document strategy in a therapeutic area.
- Lead other writers in large projects, providing framework for document content.
- Participate actively in meetings; communicate opinions and influence decisions;
- Be able to identify the correct parties for a document content decision, and if a discussion is faltering, bring it back on track with minimal fuss.
- Follow a discussion to its conclusion, synthesize the message, and present clear accurate prose quickly.
- Show managerial courage in a matrixes organization
- Be a team player
- Have a good working knowledge of PDF, and Project. Skilled in use of MS WORD. Has used 1 or more EDM systems
Contact: Heather, hballest@aerotek.com
