Principal/Associate Principal Medical Writer

Trilogy

Principal Medical Writer producing clinical regulatory documents for the international pharmaceutical industry. Leading multinational projects, timelines, reviews, budgets, and writer coordination.

Posted 8/4/2026full-timeRemote • 🇵🇹 PortugalJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in writing clinical regulatory documents, including Clinical Study Protocols and Clinical Study Reports, while managing multiple projects and adhering to regulatory guidelines. Proficient in collaborating with teams and overseeing document management processes to ensure timely and high-quality deliverables.

Highest-signal resume keywords

Lead Writer Experience on CTD DocumentsProject Management of Document TimelinesIn-Depth Knowledge of ICH, FDA, and EMA GuidanceExperience in Multiple Therapeutic AreasFluent Written and Spoken English

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study Protocol WritingClinical Study Report WritingClinical Summary WritingInvestigator Brochure WritingIMPD/IND WritingRegulatory Document PreparationStatistical CommunicationRegulatory CommunicationDocument Management SystemsReview Tools

Soft Skills

Interpersonal SkillsAttention to DetailFlexibility Under Tight Timelines

Tools & Technologies

Regulatory Document Management Systems

Industry Keywords

Clinical Trial ConductCTD FormatSOPsGlobal TeamsBudget Oversight

About the role

Key responsibilities & impact

Function as a lead writer to prepare clinical regulatory documents, including Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, and scientific publications
Collaborate with client authoring teams and other writers
Ensure documents are produced according to agreed timelines, monitor 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 assisting with assigned documents
Project manage document timelines and review cycles
Work in clients’ regulatory document management systems

Requirements

What you’ll need

At least 5 years of experience actively writing regulatory documents
Experience as a lead writer on CTD documents is mandatory
Lead-writer experience on Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, and scientific publications
Experience leading multiple-document projects with global, multinational teams, including team management, project management, review management, and budget oversight
Ability to manage multiple projects simultaneously
In-depth working knowledge of relevant regulatory guidance, including ICH, FDA, and EMA guidance for clinical trial conduct
Experience in multiple therapeutic areas
Advanced understanding of statistical, regulatory, and medical communication concepts
Competency using document management systems and review tools
Minimum of a 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

Benefits

Comp & perks

Competitive base salary
Annual bonus opportunity
A generous allowance of paid time off
Comprehensive benefit plans aligned with your region
Full EMWA membership and annual conference attendance paid for by Trilogy
Continuous personal and professional development opportunities
Free weekly yoga sessions
Other fun and exciting events that encourage team bonding and development