Associate/Principal Medical Writer

Senior/Principal Medical Writer – Remote/Hybrid/In Office - UK Location An Indegene Company (Trilogy Writing & Consulting), Cambridge, United Kingdom. Must reside in the UK, Germany, Italy, Ireland, or Portugal. Job Overview We are seeking Senior or Principal Medical Writers to create high‑quality regulatory documents for the international pharmaceutical industry. The role involves writing, coordinating, and overseeing clinical regulatory documents and collaborating with clients and internal teams. Responsibilities Prepare clinical regulatory documents (Clinical Study Protocols, Clinical Study Reports, CTD Clinical Summaries, Investigator Brochures, IMPDs/INDs, scientific publications) as lead writer. Ensure documents meet agreed timelines, monitor and manage project budgets, adhere to SOPs and client requirements. Provide document‑specific advice to clients. Oversee and coordinate other writers and QC specialists involved in documents under your responsibility. Project‑manage timelines and review cycles of your documents. Work in the client’s regulatory document management systems. Required Writing Experience Several years of professional experience actively writing regulatory documents. Experience as lead writer on ≥3 (Senior level) or ≥5 (Principal level) of the following: Clinical Study Protocols, Clinical Study Reports, CTD Clinical Summaries, Investigator Brochures, IMPDs/INDs, scientific publications. For Principal level: experience with at least two different CTD dossier types (e.g., full new chemical entity, variation, generic, orphan, literature‑based). Direct client interaction, coordinating review cycles, meetings, and project timelines. For Principal level: willingness to take on any project requiring a Lead Writer. Competency using document management systems and review tools. Additional Qualifications Diploma/Master’s/Bachelor’s degree in science or pharmacy (Ph.D. not required). Fluent written and spoken English. Attention to detail and appreciation for high‑quality documents. Excellent interpersonal skills and ability to work proactively in a diverse team. Flexibility and focus under tight timelines. Must live in the UK, Germany, Italy, Ireland, or Portugal. Remuneration & Benefits Competitive salary commensurate with experience, along with standard Trilogy benefits. Application Requirements Eligible for full remote or hybrid remote work from our UK office in Cambridge. Submission of documents in English. Cover letter detailing how you meet the experience requirements. Curriculum Vitae. Equal Employment Opportunity Trilogy Writing & Consulting, An Indegene Company, complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state/provincial, and local law. We passionately believe in creating a supportive environment in which everyone can grow, flourish, and do their best work. Data Privacy Statement Collection and use of personal data in the application process: It is important to Trilogy to ensure the highest possible degree of protection for your personal data. All personal data collected and processed within the scope of an application for employment with Trilogy are protected against unauthorized access and manipulation by technical and organizational measures, and are not forwarded to third parties. Your data will be collected for the purpose of filling employment opportunities offered by Trilogy Writing & Consulting GmbH in Germany or its subsidiaries Trilogy Writing & Consulting Ltd in the UK, and Trilogy Writing & Consulting, Inc. in the USA. By submitting your data with this application you consent to its use for this purpose within Trilogy. You can revoke this consent at any time without needing to give a reason by informing us of your revocation under jobs@trilogywriting.com. In the event of revocation, we will delete your personal data immediately. #J-18808-Ljbffr