Medical Writer - CSR (Clinical Study Report)
Job Responsibilities :
The Medical Writer will research, create, edit, and coordinate the production of clinical and regulatory submission documents, including clinical study reports, protocols, and safety update reports, etc.The Medical Writer may provide writing support for more complex clinical documentation, with appropriate departmental supervision. The Medical Writer may serve as primary technical contact with client under appropriate departmental supervision.
Key responsibilities and skills may include, but are not limited to:
- Serve as the primary client contact under departmental supervision.
- Serve as the Medical Writing representative on assigned project teams, providing support to Project for developing efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables.
- Providing support to Business Development Department for project bidding, document review and forecasting timeline.
- Write clinical documents associated with submissions to regulatory authorities.
- Serve as QCer to review peer`s clinical documents.
- Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.
- Ensure document content and style adheres to appropriate regulatory guidelines and complies with departmental and corporate or client SOPs and style guidelines.
- Coordinate production and distribution of draft and final documents to project team and client.
- Ensure that all work is complete and of high quality prior to team distribution or shipment to client.
- Perform literature searches/reviews as necessary to obtain background information and training for development of documents.
- Attend internal technical team and client team meetings as required.
- Keep abreast of professional information and technology through workshops and conferences and ensure the appropriate transfer of that information to the department.
- Participate in departmental or interdepartmental process improvement and training initiatives.
- Other assignment duties as assigned by department management.
Candidate Profile :
- Bachelor’s degree or above in Life Sciences/Health Related Sciences or equivalent.
- Fluent in written and spoken English.
- The candidate should have experience of the eCTD Module.
- Experience in the pharmaceutical industry or medical writing.
- Experience of 3-4 years of medical writing of regulatory documents such as CSR, protocol or similar in a contract research organization, pharmaceutical or biotechnology firm, or some experience in the conduct of clinical research/medical communications.
- Good clinical/scientific writing skills.
- Excellent interpersonal, verbal and written communication skills.
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
- Good word processing skills/familiarity with Word for Windows.