Vice President, Medical Writing
$250,000 - $350,000 (DOE.)
Benefits: Bonus, 401 (K), Stock options, Healthcare & Dental
My client is a leading mid-sized biotechnology company that are pioneers in developing treatments across a number of therapy areas.
My client is looking for a Vice President, Medical Writing to join and lead their Medical Writing team, you will have at least 10+ years of relevant industry experience ideally in the Biotechnology setting. This is a full time position providing complete strategic oversight, leadership and hands on involvement in regulatory submissions for ongoing clinical studies.
Role Responsibilities:
- Act as a lead writer preparing regulatory submissions and key response documents.
- Provide expertise including organization, content, timelines, and resourcer requirements.
- Serve as lead writer for strategic regulatory documents and important aspects of regulatory submissions.
- Coordinate and provide oversight of the activities of medical writing vendors and resolve issues.
- Provide complex and advanced input for study designs, analysis plans, INDs, and marketing applications.
- Support junior members of staff in their development
Role Requirements:
- PhD or High Science degree
- Minimum 10+ years experience writing for biotech or pharma.
- Demonstrated understanding of FDA/international regulations, ICH guidelines, and US/international regulatory processes in regards to document prepatation and production.
- Expert knowledge of clinical development including but not limited to the phases, processes, and techniques used within clinical development.
- Excellent oral and written communication skills and the ability to clearly present technical information across functional areas.
For further information, contact us on: +44 (0) 796 3179929.
Alternatively, email me with your CV at: Jake.byrne@albionryeassociates.com