Associate Director, Medical Writing
$180,000 - $240,000
Benefits: Bonus, 401 (K), Stock options, Healthcare & Dental
2/3 days office based in Cambridge, MA
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 Associate Director, Medical Writing to join their team, you will have at least 6 years of relevant industry experience ideally in the Biotechnology setting. This is a full time position offering a flexible working environment split between home and office.
Role Responsibilities:
- Act as a senior 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 4 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