Senior Medical Writer & Evidence Analyst

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

• 3–5 yrs of experience
• Quality control
• SOP writing
• Documentation
• Communication
• M.Pharm or PhD