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Principal Medical Writer
3 weeks ago
We are seeking a highly skilled medical writer to join our team. The ideal candidate will have a strong background in quality control (QC) of regulatory documents and a keen eye for detail.
The role involves compiling, writing, and editing various medical writing deliverables to ensure scientific information is presented clearly and accurately.
- Quality Control & Compliance:
- Perform QC of regulatory documents, including protocols, CSRs, and IBs.
- Adhere to established regulatory standards, such as ICH E3 guidelines, and company SOPs.
- Content Creation & Documentation:
- Compile, write, and edit a wide range of documents, 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 for accuracy and consistency.
- Collaboration & Project Management:
- Lead document reviews, resolve comments from clients, and ensure appropriate management of source documentation.
- Interact and build good working relationships with clients, department heads, and peers.
- Mentorship & Professional Development:
- Mentor less-experienced medical writers on projects as needed.
- Maintain a strong working knowledge of the drug development process, regulatory guidelines, and best practices.
