Description
I have a requirement for a Phase 1 Regulatory Medical Writer (Phase 1/PK/Protocol/CSR/IB's/Reg) to join a Phase 1 Medical Writing Group on a fully remote 12 month contract.Document Experience:
-Extensive experience writing protocols, CSRs, IB's and summaries at the Phase 1 level (PK, dose escalation, ADME)
-Experience writing submission level documents (CTD, including ISS, ISE, GIP, and CO) for IND and NDA.
-Protocols, investigator brochures, briefing documents, narratives, and informed consent forms
- Worked closely with PK and Statistics to interpret clinical data for regulatory documents.
-Experience in biomedical and pharmaceutical databases
- Experience Integrating clinical data into original summary documents
If you are interested in this position or other medical writing opportunities, please attach an up to date resume and I will be in touch.