Principal Medical Writer – Client Embedded

Thermo Fisher Scientific

. Research, write, and edit clinical study reports and study protocols .

Posted 11/11/2026full-timeRemote • SerbiaLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory writing and project management within the pharmaceutical and CRO industries, with a strong focus on compliance, document development, and mentoring. Proficient in data interpretation and effective communication, ensuring high-quality clinical documentation.

Highest-signal resume keywords

Regulatory WritingProject ManagementClinical Study ReportsDocument Development GuidelinesMentoring Junior Staff

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study ReportsData InterpretationMedical WritingDocument DevelopmentProject ManagementGrammatical SkillsEditorial SkillsProofreading SkillsProcess ImprovementBudget Development

Soft Skills

Interpersonal CommunicationOral CommunicationWritten CommunicationNegotiation SkillsJudgment

Tools & Technologies

Document-Development Software

Certifications & Qualifications

AMWAEMWARAC

Industry Keywords

Pharmaceutical IndustryCRO IndustryRegulatory RequirementsTherapeutic-Area KnowledgeClient PresentationsProposal ReviewBid Defense MeetingsProject Launch Meetings

About the role

Key responsibilities & impact

Research, write, and edit clinical study reports and study protocols
Summarize data from clinical studies
Serve as primary author and provide input on complex clinical, scientific, and program-level documents, including IBs, INDs, and MAAs
Provide senior-level review of routine and complex documents
Train and mentor writers and program managers on document preparation, document-development software, document types, regulatory requirements, and therapeutic-area knowledge
Ensure compliance with quality processes and requirements for assigned documents
Develop and review best practices, methods, and techniques as a subject matter expert
Lead process improvement initiatives, including client-specific processes
Potentially serve as backup program manager
Identify and resolve out-of-scope activities
Develop timelines, budgets, forecasts, and contract modifications as needed
Assist business development with client presentations and proposal text review
Attend bid defense meetings and capabilities presentations
Represent the department at project launch, review, and project team meetings
Collaborate with internal and external teams to support effective communication and operational excellence

Requirements

What you’ll need

Bachelor's degree in a scientific discipline or equivalent and relevant formal academic/vocational qualification required
Advanced degree preferred
At least 8 years' experience in regulatory writing
Experience managing and directing complex medical writing projects
Experience working in the pharmaceutical/CRO industry
Significant knowledge of global, regional, national, and other document development guidelines
In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, submissions, or communications
Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
Excellent project management skills
Advanced interpersonal, oral and written communication, and presentation skills
Excellent negotiation skills
Excellent judgment and a high degree of independence in decision-making and problem-solving
Ability to mentor and lead junior-level staff
Additional qualifications in medical writing (AMWA, EMWA, RAC) advantageous

Benefits

Comp & perks

Award-winning learning and development programme
Competitive salary
Extensive benefits package focused on employee health and well-being
Flexible working culture
Work-life balance
Collaborative environment
Opportunities to share expertise and grow professionally and personally