Senior Medical Writer

21 hours ago

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Trilogy

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Automotive configuration software • Financial services channel compensation software • telecommunications network management software • telecommunications channel compensation software

201 - 500

Description

• Prepare a variety of clinical regulatory documents in collaboration with client teams • Ensure documents are produced according to timelines and budgets • Provide document-specific advice to clients • Oversee and coordinate other writers and QC specialists • Project manage timelines and review cycles of documents • Work in 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 specific documents • For Principal Medical Writer level, experience in at least 2 different types of CTD dossiers • Experience interacting directly with clients or authors • For Principal Medical Writer level, ability and willingness to take 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 (Ph.D. not necessary) • Fluent written and spoken English skills • Appreciation for a well-written document and an eye for details • Excellent interpersonal skills and teamwork capabilities • Flexibility and ability to stay focused under tight timelines

Benefits

• Remuneration will be relative to the level of experience • All standard Trilogy benefits