Principal Medical Writer

This is a fully remote position, open to applicants in Germany, +3 more states.

📋 Description

• Lead the preparation of a range of clinical regulatory documents in collaboration with client authoring teams and other writers.

• Ensure that all documents adhere to agreed timelines, project budgets, applicable SOPs, Trilogy standards, and client specifications.

• Offer document-specific guidance to clients.

• Supervise and coordinate the efforts of other writers and quality control specialists.

• Manage project timelines and document review cycles effectively.

• Operate within clients’ regulatory document management systems.

⛳️ Requirements

• Relevant professional experience in actively writing regulatory documents.

• Served as the lead writer on more than 5 documents across at least 3 specific document types, which include clinical study protocols, clinical study reports, CTD clinical summaries, investigator brochures, IMPDs/INDs, scientific publications, PSUR/DSUR, PBRER, RMP, or PIP.

• Proven experience with at least 2 different types of CTD dossiers.

• Direct interaction experience with clients or document authors.

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

• Willingness and capability to undertake projects requiring a Lead Writer.

• Proficient in document management systems and review tools.

• Holds a Diploma, Master's, or Bachelor's degree in science or pharmacy; a Ph.D. is not required.

• Fluent in written and spoken English.

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

• Exceptional interpersonal skills demonstrated through previous experiences.

• Ability to remain focused and adaptable under tight deadlines.

• Candidates must reside in Germany, Portugal, Italy, or Ireland.

• Freelancers are not encouraged to apply.

• Submission of an English cover letter detailing compliance with the experience requirements along with a CV is required.

🏝️ Benefits

• Standard benefits provided by Trilogy.

• A supportive environment where everyone can thrive, develop, and perform at their best.

• Option for fully remote work.

• Opportunities for office-based or hybrid working arrangements.