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Senior/Principal Medical Writer
TrilogySenior/Principal Medical Writer producing clinical regulatory documentation for the international pharmaceutical industry. Leading writing, client coordination, review cycles, timelines, budgets, and regulatory document management.
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 collaborating with client teams. Proficient in using document management systems and ensuring compliance with regulatory standards.
Highest-signal resume keywords
Clinical Regulatory Document PreparationLead Writer ExperienceCTD Dossier KnowledgeDocument Management Systems ProficiencyClient Interaction Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Study ProtocolsClinical Study ReportsClinical SummariesInvestigator BrochuresIMPDs/INDsScientific PublicationsRegulatory Document WritingProject ManagementReview Cycle CoordinationAttention to Detail
Soft Skills
Interpersonal SkillsFlexibilityFocus Under Tight Timelines
Tools & Technologies
Regulatory Document Management SystemsReview Tools
Industry Keywords
SOPsTrilogy RequirementsClient RequirementsDocument-Specific Advice
About the role
Key responsibilities & impact- Prepare clinical regulatory documents including Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in CTD format, Investigator Brochures, IMPDs/INDs, and scientific publications as lead writer
- Collaborate with client authoring teams and other writers
- Ensure documents meet agreed timelines, project budgets, SOPs, Trilogy requirements, 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
- Senior Medical Writer: lead writer on more than 3 documents across at least 3 specified document types
- Principal Medical Writer: lead writer on more than 5 documents across at least 3 specified document types
- Principal Medical Writer: 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 Medical Writer: ability and willingness to take on any project requiring a Lead Writer
- Competency using 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 be eligible to work in Ireland
- Must be based in Ireland
- Freelancers need not apply
- Submit a cover letter explaining compliance with the stated experience requirements and a CV
Benefits
Comp & perks- Standard Trilogy benefits
- Supportive environment in which everyone can grow, flourish, and do their best work
- Equal employment opportunity and non-discrimination