Senior/Principal Medical Writer

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Lead the preparation of clinical regulatory documents, including Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in CTD format, Investigator Brochures, IMPDs/INDs, and scientific publications.

• Work collaboratively with client authoring teams and other writers.

• Create documents within established timelines and manage project budgets effectively.

• Comply with relevant SOPs while meeting the standards set by Trilogy and our clients.

• Offer document-specific guidance to clients.

• Supervise and coordinate writers and QC specialists.

• Manage project timelines and review cycles for documents.

• Utilize clients’ regulatory document management systems.

⛳️ Requirements

• Several years of hands-on experience in writing regulatory documents.

• Served as the lead writer on over 3 projects at the Senior Medical Writer level or more than 5 projects at the Principal Medical Writer level, encompassing at least 3 specified document types.

• For the Principal level: experience in at least 2 distinct types of CTD dossiers.

• Proven experience in direct interaction with clients or document authors.

• Skilled in coordinating review cycles, meetings, and project timelines.

• For the Principal level: readiness and capability to take on any project requiring a Lead Writer.

• Proficient in document management systems and review tools.

• Degree in science or pharmacy (Diploma, Master’s, or Bachelor’s); a Ph.D. is not required.

• Fluent in written and spoken English.

• Strong appreciation for well-crafted documents and meticulous attention to detail.

• Excellent interpersonal skills and a proactive approach to teamwork.

• Ability to maintain focus and adaptability under tight deadlines.

• Must have eligibility to work in the UK.

• Freelancers are not encouraged to apply.

• Submission of documents in English is required, including a cover letter detailing compliance with experience requirements and a CV.

🏝️ Benefits

• Standard Trilogy benefits.

• A supportive environment that fosters growth, flourishing, and the ability to perform at one's best.