Senior Medical Writer
New
United StatesFull-TimeSenior
Salary130,000 - 150,000 USD per year
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Job Details
- Experience
- 4+ years of medical writing experience in Sponsor or CRO setting
Requirements
- Bachelor’s degree in a scientific discipline
- 4+ years of medical writing experience in Sponsor or CRO setting
- Knowledge of drug development and study conduct processes
- Understanding of ICH guidelines and FDA/EU guidance
- Experience with Veeva RIM
- Strong verbal and written communication skills
- Detail-oriented and organized
Responsibilities
- Prepare regulatory documents including IND, NDA, MAA, protocols, and clinical study reports.
- Serve as writing lead on assigned documents.
- Collaborate with cross-functional teams such as Clinical Pharmacology, Toxicology, and Regulatory Affairs.
- Support clinical trial transparency and disclosures on databases like clinicaltrials.gov and EudraCT.
- Contribute to editorial and review support for document templates and SOPs.
- Ensure adherence to SOPs and internal best practices.
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