Senior Medical Writer & Evidence Analyst
RemoteFull-time3–5 yrsPosted 1 week ago
Mid-level pharma role at Catalyst Clinical Research. Needs 3–5 years and an M.Pharm or PhD. Remote.
About the role
independently or with other Sr Medical Writer as per high-quality standards (internal & external) and within expected timelines. Support other writers for manuscripts, slide sets, abstracts, posters, other techno-commercial documents as needed.
What you'll do
- Authoring & review of patient narratives, CSRs, Protocol, IB, & other regulatory submission documents (excluding CTD modules) for US FDA, EMEA and rest of the world
- Independent authoring and review of manuscripts, abstracts, posters, evidence synthesis projects and other techno-commercial documents as needed
- Author deliverables with scientific accuracy, based on facts from available sources and meeting quality standards (including grammar and editorial requirements)
- Follow all internal and client processes and adhere to various ICH / regulatory guidelines and other industry best practices (e.g. GPP)
- Undertake quality control (QC, scientific reviews and/or proofreading of the above-mentioned deliverables
What you need
- Quality control
- SOP writing
- Documentation
- Communication