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Posted 3 weeks agoMedical Writer - Narratives
at Fortrea
Manila, PhilippinesOn-site
Responsibilities
- Ensure timely delivery of high-quality documents to internal customers and Sponsors.
- Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time. Summary of
- Prepare and compile CSR appendices.
- Prepare lower complexity documents such as synoptic or abbreviated CSRs, and skeleton CSRs, under guidance of more senior staff as appropriate.
- Prepare documents in accordance with Fortrea/Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines.
- Prepare and review patient safety narratives.
Requirements
- Qualifications (Minimum Required): Completed degree in life sciences e.g.
- Nursing, Pharmacy, Medical Technology, Physical Therapy Pharmacist or Nursing license highly preferred Advanced degree (e.g., PhD or Masters) preferred. 3 or more years of Medical Writing
- experience in any of the following: clinical studies, drug safety, medical journals, etc. Learn more about our EEO & Accommodations request here .
Additional details
- Job Overview: Responsible for preparation and review of clinical documents such as patient safety narratives and clinical study report (CSR) appendices.
- Responsible for preparing lower complexity documents such as synoptic or abbreviated CSRs under guidance of more senior staff.
- Assist Medical Writers in the preparation and background writing of clinical study protocols, CSRs, and subject narratives.
- Assist Medical Writers in the archiving and filing of clinical study protocols and CSRs and associated documentation.
- Provide support to project management of narrative projects.
- Provide support to more experienced colleagues with the preparation of clinical study protocols and CSRs.
- Under guidance, incorporate internal and/or external review comments on clinical documentation.