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- Available to work on site 2 days/week and MUST commit 40 hours of work.
- Degree in the biological/medical sciences – MS, PhD, MPH, PharmD or similar preferred.
- A minimum of 5-7 years experience in writing CSR, Protocols & Narratives, preparing of documents (or product information for regulatory submissions ) in the pharmaceutical or biotechnology industry, either in a sponsor company or a CRO.
- A thorough knowledge of statistics as used in analytical/interpretative writing
- Detailed knowledge of FDA and ICH guidelines and regulations related to the format, content and integrity of documents.
- Competent in computer software used in medical writing (e.g., Microsoft Word, Excel, Reference Update and Manager, Literature Search engines).