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Senior/Principal Medical Writer
TrilogySenior/Principal Medical Writer producing clinical regulatory documents for the international pharmaceutical industry. Leading client collaboration, document reviews, timelines, budgets, and writer coordination.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in preparing clinical regulatory documents, including Clinical Study Protocols and Clinical Study Reports, while effectively managing project timelines and budgets. Proficient in collaborating with clients and overseeing writing teams to ensure compliance with regulatory standards.
Highest-signal resume keywords
Lead Writer ExperienceClinical Study ProtocolsCTD Dossier PreparationDocument Management SystemsInterpersonal Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Study ProtocolsClinical Study ReportsClinical SummariesInvestigator BrochuresIMPDsINDsScientific PublicationsProject ManagementRegulatory Document WritingDocument Review Coordination
Soft Skills
Attention to DetailProactive Team ParticipationFlexibilityFocus Under Tight Timelines
Tools & Technologies
Regulatory Document Management SystemsReview Tools
Industry Keywords
SOPsCTD FormatClient CollaborationDocument-Specific AdviceQuality Control Specialists
About the role
Key responsibilities & impact- Prepare clinical regulatory documents as lead writer, including Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in CTD format, Investigator Brochures, IMPDs/INDs, and scientific publications
- Collaborate with client authoring teams and other writers
- Produce documents according to agreed timelines and manage project budgets
- Adhere to relevant SOPs and meet Trilogy and client requirements
- Provide document-specific advice to clients
- Oversee and coordinate writers and QC specialists
- Project manage document timelines and review cycles
- Work in clients’ regulatory document management systems
Requirements
What you’ll need- Several years of professional experience actively writing regulatory documents
- Lead writer on more than 3 projects at Senior Medical Writer level or more than 5 projects at Principal Medical Writer level, covering at least 3 specified document types
- Principal level: 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
- Principal level: ability and willingness to take on any project requiring a Lead Writer
- Competency in 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 and proactive team participation
- Flexibility and ability to stay focused under tight timelines
- Must be eligible to work in the UK
- Freelancers need not apply
- Submission of documents in English, including a 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