
Senior Medical Content Specialist
20 hours ago
We are seeking a highly skilled Medical Writer to join our team. The ideal candidate will have a strong background in CSR (Clinical Study Report) safety narratives writing and be able to compile, write, edit, and coordinate a wide range of medical writing deliverables with a primary focus on CSR safety narratives.
Key Responsibilities:
- Compile, write, edit, and coordinate medical writing deliverables including clinical study protocols, clinical study reports, patient narratives, investigator brochures, and periodic safety update reports.
- Review statistical analysis plans and table/figure/listing specifications to ensure content and formatting are consistent and appropriate.
- Adhere to established regulatory standards, including ICH E3 guidelines, and internal SOPs.
- Coordinate quality and editorial reviews and act as a peer reviewer for the internal team.
Qualifications:
- A Bachelor's degree in a relevant discipline with a graduate degree preferred.
- At least professional experience in science, technical, or medical writing.
- Experience in the biopharmaceutical, device, or contract research organization industry is a plus.
- Familiarity with FDA and ICH regulations and AMA Manual of Style.
- Extensive knowledge of English grammar and the ability to communicate clearly.
As a Medical Writer, you will play a crucial role in producing high-quality medical writing deliverables that meet the needs of our clients. You will work closely with cross-functional teams to develop and implement effective medical writing strategies.
The ideal candidate will be a skilled writer with excellent communication skills and the ability to work effectively in a fast-paced environment.
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