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Principal Medical Writer
TrilogyPrincipal Medical Writer preparing clinical regulatory documentation for international pharmaceutical companies. Leading authoring, client coordination, review cycles, budgets, and timelines across therapeutic areas.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in writing and managing clinical regulatory documents, ensuring compliance with timelines, budgets, and client specifications. Proficient in coordinating teams and project timelines while maintaining high standards of document quality and attention to detail.
Highest-signal resume keywords
Lead Writer ExperienceClinical Regulatory Document WritingProject ManagementDocument Management SystemsClient Interaction
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Study ProtocolsClinical Study ReportsCTD Clinical SummariesInvestigator BrochuresIMPDs/INDsScientific PublicationsPSUR/DSURPBRERRMPPIP
Soft Skills
Interpersonal SkillsAttention to DetailFlexibilityFocus Under Tight Timelines
Tools & Technologies
Regulatory Document Management SystemsReview Tools
Certifications & Qualifications
Bachelor's Degree in Science or PharmacyMaster's Degree in Science or Pharmacy
Industry Keywords
Clinical Regulatory DocumentsSOPsTrilogy Requirements
About the role
Key responsibilities & impact- Prepare a variety of clinical regulatory documents as the lead writer in collaboration with client authoring teams and other writers
- Ensure documents meet agreed timelines, project budgets, relevant SOPs, Trilogy requirements, and client requirements
- Provide document-specific advice to clients
- Oversee and coordinate other writers and QC specialists
- Project manage document timelines and review cycles
- Work in clients’ regulatory document management systems
Requirements
What you’ll need- Relevant professional experience actively writing regulatory documents
- Lead writer on more than 5 documents in at least 3 specified document types, including clinical study protocols, clinical study reports, CTD clinical summaries, investigator brochures, IMPDs/INDs, scientific publications, PSUR/DSUR, PBRER, RMP, or PIP
- Experience in at least 2 different types of CTD dossiers
- Experience interacting directly with clients or document authors
- Experience coordinating review cycles, meetings, and project timelines
- Ability and willingness to take on projects requiring a Lead Writer
- Competency with document management systems and review tools
- Diploma, Master's, or Bachelor's degree in science or pharmacy; Ph.D. not necessary
- Fluent written and spoken English
- Appreciation for well-written documents and strong attention to detail
- Excellent, proven interpersonal skills
- Flexibility and ability to stay focused under tight timelines
- Must live in Germany, Portugal, Italy, or Ireland
- Freelancers need not apply
- Submission of an English cover letter explaining compliance with the experience requirements and a CV
Benefits
Comp & perks- Standard Trilogy benefits
- Supportive environment in which everyone can grow, flourish, and do their best work
- Fully remote work option
- Office-based or hybrid work option