Senior Medical Writer

21 hours ago

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Description

• Prepare a variety of clinical regulatory documents as the lead writer in collaboration with members of client authoring teams. • Ensure that all documents are produced according to agreed timelines and monitor project budgets. • Provide document-specific advice to clients. • Oversee and coordinate other writers and QC specialists assisting on documents. • Project manage the timelines and review cycles of documents. • Work in the client’s regulatory document management systems.

Requirements

• Relevant professional experience actively writing regulatory documents. • Worked as the lead writer on at least >3 (Senior Medical Writer) or >5 (Principal Medical Writer) of the following: Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications. • For the Principal Medical Writer level, experience in at least 2 different types of CTD dossiers. • Experience interacting directly with clients or authors of the documents and coordinating review cycles, meetings, and project timelines. • Ability and willingness to take on any project for which a Lead Writer is needed. • Competency in the use of document management systems and review tools. • Diploma/Master's/Bachelor’s degree in science/pharmacy. • Fluent written and spoken English skills. • An appreciation for a well-written document and an eye for details. • Excellent, proven interpersonal skills, and enjoy proactively participating on a team with diverse personalities.

Benefits

• Flexibility and the ability to stay focused under tight timelines. • Remuneration will be relative to the level of experience, with all standard Trilogy benefits.