Senior Medical Writer – Sponsor Dedicated, CSR, Protocols, IB, Reg Documents

Syneos Health

. Lead the clear and accurate completion of medical writing deliverables .

Posted 9/24/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in medical writing, including the completion of clinical study protocols, reports, and regulatory submissions while adhering to ICH and FDA guidelines. Proven ability to manage writing activities, mentor junior writers, and collaborate effectively across departments.

Highest-signal resume keywords

Regulatory Writing ExperienceClinical Study Protocol DevelopmentICH E3 Guidelines AdherenceAMA Manual of Style FamiliarityBiopharmaceutical Industry Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study ProtocolsClinical Study ReportsIND SubmissionsNDA SubmissionsStatistical Analysis PlansPatient NarrativesInformed ConsentsAnnual ReportsJournal ManuscriptsAbstracts

Soft Skills

Clear CommunicationMentoringProblem SolvingCollaborationTechnical Support

Industry Keywords

BiopharmaceuticalDevice IndustryContract Research OrganizationFDA RegulationsEMA RegulationsGood Publication PracticesSource DocumentationQuality ReviewsEditorial ReviewsCopyright Compliance

About the role

Key responsibilities & impact

Lead the clear and accurate completion of medical writing deliverables
Manage medical writing activities for individual studies with minimal supervision
Coordinate medical writing activities within and across departments
Lead resolution of client comments
Complete clinical study protocols, protocol amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, abstracts, posters, and presentations
Adhere to ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style and formatting guides
Coordinate quality and editorial reviews and manage source documentation
Lead team document reviews and act as a peer reviewer
Review statistical analysis plans and table/figure/listing specifications
Collaborate with clients and data management, biostatistics, regulatory affairs, and medical affairs teams
Perform online clinical literature searches and comply with copyright requirements
Identify and resolve issues, escalating as appropriate
Provide technical support, training, and consultation
Contribute to internal materials, presentations, processes, standards, and capabilities
Mentor and lead less experienced medical writers on complex projects
Develop expertise in industry topics and regulatory requirements
Monitor budgeted hours and communicate status and changes to medical writing leadership
Complete administrative tasks and other assigned duties

Requirements

What you’ll need

3-5 years of relevant experience in regulatory writing
Experience working in the biopharmaceutical, device, or contract research organization industry required
Strong understanding of EMA, FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required
Experience writing relevant document types required
Extensive knowledge of English grammar and ability to communicate clearly
Strong familiarity with AMA Manual of Style
Minimal travel may be required (less than 25%)
Equivalent experience, skills, and/or education will also be considered

Benefits

Comp & perks

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Inclusive culture
Reasonable accommodations, when appropriate, under the Americans with Disabilities Act