Job description

A mid-sized life science company in the greater Boston area is looking to bring on a Medical Writer (Regulatory) to support them for the next 6-12 months. This position is fully remote and will focus on providing both clinical and regulatory support, with a strong emphasis on the regulatory. In this role, you will review various regulatory documents such as IBs, CSR’s and Data Summary’s for IND’s and possibly a BLA ins 2024. Ideal candidates will have 10+ years of experience, will come from a strong scientific background working in chemistry & biology (molecular biology preferred) and will be well versed in all writing regulatory documents.

Top skills:

• 10+ years of writing experience in both clinical and regulatory (should be stronger on the regulatory side of things)
• Prior experience writing various regulatory documents such as: IBs, CSR’s and Data Summary’s, ect..
• Prior experience supporting IND filings (prior experience supporting BLAs is preferred)
• Must come from a strong scientific background in Chemistry or Biology (molecular biology preferred)

Job Types: Full-time, Contract

Pay: $70.00 - $90.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Experience:

• Medical Writing: 7 years (Required)
• Chemistry of Biology: 3 years (Preferred)

Work Location: Remote

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