Job Description
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. Ensure timely delivery of high-quality documents to internal customers and Sponsors. Assist Medical Writers in the archiving and filing of clinical study protocols and CSRs and associated documentation. 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 Responsibilities:
- Prepare and review patient safety narratives.
- Provide support to project management of narrative projects.
- 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.
- Provide support to more experienced colleagues with the preparation of clinical study protocols and CSRs.
- Prepare documents in accordance with Fortrea/Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines.
- Under guidance, incorporate internal and/or external review comments on clinical documentation.
- Communicate with internal/external clients as needed to facilitate achievement of project goals.
- Comply with Fortrea internal processes and procedures.
- Performs other duties as assigned by Management.
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.
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