About the role
Key Responsibilities:
- Author and develop Clinical Study Reports (CSRs), clinical protocols, and protocol amendments
- Develop/edit regulatory documents, including IBs, IND, and MAA submissions
- Review and mentor junior medical writers
- Ensure documents meet regulatory, quality, and client requirements
- Collaborate with clinical, regulatory, and cross-functional teams
- Support project timelines and delivery of regulatory documents
Requirements:
- 5+ years of relevant medical writing experience
- Bachelor's degree in a scientific discipline; advanced degree preferred
- Experience in pharmaceutical, biotech, or CRO environments preferred
- Strong scientific, medical, regulatory, and technical writing skills
- Experience with clinical trials and regulatory documentation
- AMWA, EMWA, or RAC certification is a plus
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