Senior Regulatory Medical Writer, Client-Embedded, FSP

Thermo Fisher Scientific

. Serve as a primary author for routine clinical documents such as clinical study reports and study protocols .

Posted 10/9/2026full-timeRemote • North Carolina • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in authoring clinical regulatory documents, including clinical study reports and protocols, while ensuring compliance with regulatory guidelines and industry best practices. Strong project management and mentoring abilities are essential for overseeing junior medical writers and managing timelines effectively.

Highest-signal resume keywords

Clinical Regulatory Document AuthoringProject ManagementMedical Writing SkillsInterpersonal CommunicationDocument Development Guidelines Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study Report AuthoringData InterpretationProofreading SkillsDocument Structure and PresentationRegulatory Guidelines Compliance

Soft Skills

Problem-SolvingNegotiation SkillsOral CommunicationWritten CommunicationPresentation Skills

Tools & Technologies

Document Management SystemsExcelOutlookClient Templates

Certifications & Qualifications

AMWAEMWARAC

Industry Keywords

Pharmaceutical IndustryCRO IndustryClinical StudiesBioassay ReportsINDsMAAs

About the role

Key responsibilities & impact

Serve as a primary author for routine clinical documents such as clinical study reports and study protocols
Summarize data from clinical studies
Author complex clinical, scientific, and program-level documents, including IBs, bioassay reports, INDs, and MAAs
Collaborate with cross-functional teams and internal and external clients to gather information and ensure document accuracy and completeness
Ensure documents align with regulatory guidelines, company standards, and industry best practices
Provide input on document content, structure, and presentation
Review and provide feedback on documents prepared by other team members
Manage timelines and deliverables for assigned projects
Mentor and oversee junior medical writers
Assist the program manager as needed
Stay current with industry trends, guidelines, and regulatory requirements

Requirements

What you’ll need

Bachelor's degree in a scientific discipline or equivalent relevant formal academic/vocational qualification
Advanced degree preferred
5+ years of previous experience providing relevant knowledge, skills, and abilities
Experience working in the pharmaceutical/CRO industry preferred
Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
Proven track record authoring clinical regulatory documents
Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
Strong project management skills
Excellent interpersonal, problem-solving, negotiation, oral, written communication, and presentation skills
Significant knowledge of global, regional, national, and other document development guidelines
Excellent computer skills and proficiency with client templates
Good knowledge of document management systems and relevant applications such as Excel and Outlook
Ability to meet requirements through an equivalency of appropriate education, training, and/or directly related experience may be considered

Benefits

Comp & perks

Award-winning learning and development program
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 develop professionally and personally