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Job: Medical Writer (Remote, ClinSearch Resources, Remote, NC
Medical Writer (Remote
Remote, NC 27513 United States
Health/Vision/Dental benefits for full time employees
The Medical Writer - 100% Remote - role Full-Time or Part Time candidates will be considered -
Prepare a variety of clinical regulatory documents (as described above) as the lead writer in collaboration with members of client authoring teams and supported by other writers, as appropriate.
The Medical Writer will ensure that all documents are produced according to agreed timelines, monitor and manage project budgets, adhere to relevant SOPs, and meet the requirements of the company as well as the company’s clients.
Be responsible for providing document-specific advice to clients.
The Medical Writer will oversee and coordinate other writers and QC specialists assisting on documents under your responsibility.
Project manage the timelines and review cycles of your documents.
Work in the client’s regulatory document management systems.
Need to have experience in one of the 4 following areas:
Clinical Study Protocols, Clinical Study Reports, Investigator Brochures, IMP/IND’s
Bachelor's degree required, advanced degree preferred
4+ years of Regulatory Medical Writer experience in Biopharmaceutical/CRO industry
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North Carolina Biotechnology Center