Regulatory Document Medical Writer
3 weeks ago
ClinChoice is seeking a highly skilled Regulatory Document Medical Writer to join our team.
About the Role:
The Medical Writer will be responsible for researching, creating, editing, and coordinating the production of clinical and regulatory submission documents, including clinical study reports, protocols, CTD sections, IB, and safety update reports.
Responsibilities:
- Serve as the primary client contact under departmental supervision.
- Provide writing support for more complex clinical documentation, with appropriate departmental supervision.
- Write/review clinical documents associated with submissions to regulatory authorities.
- Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution.
- Ensure document content and style adheres to appropriate regulatory guidelines and complies with departmental and corporate or client SOPs and style guidelines.
- Perform literature searches/reviews as necessary to obtain background information and training for development of documents.
- Coordinate production and distribution of draft and final documents to project team and client.
Requirements:
- Qualification: Bachelor's degree or above in Life Sciences/Health Related Sciences or equivalent.
- Should have 10-13 years of experience in medical writing of regulatory documents such as CSR, protocol, CTD sections or similar in a contract research organization, pharmaceutical or biotechnology firm, or some experience in the conduct of clinical research/medical communications.
- Experience in the pharmaceutical industry or medical writing. Specific experience in Oncology and Neurology Therapeutic areas.
What We Offer:
- Opportunity to work with a leading contract research organization.
- Collaborative and dynamic work environment.
- Competitive salary and benefits package.
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