Senior Medical Writer – Regulatory Focus

Syneos Health

. Lead clear and accurate completion of medical writing deliverables .

Posted 10/23/2026full-timeRemote • Canada, United States, United KingdomSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in medical writing, including the preparation of clinical study protocols, reports, and regulatory submissions, while effectively managing project timelines and collaborating with cross-functional teams. Proven ability to mentor junior writers and ensure compliance with industry standards and guidelines.

Highest-signal resume keywords

Lead Regulatory Writing ExperienceClinical Study ProtocolsIND SubmissionsProject Management SkillsClient Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study ReportsInvestigator BrochuresPatient NarrativesCTD Modules 2.7.3 and 2.7.4Safety Aggregate ReportsStatistical Analysis PlansICH E3 GuidelinesTechnical SupportDocument ReviewsOnline Clinical Literature Searches

Soft Skills

Strong Time Management SkillsStrong Project Management Skills

Industry Keywords

Regulatory RequirementsClinical Development PlansNDA SubmissionsECTD SubmissionsPlain Language SummariesPeriodic Safety Update ReportsCollaboration with BiostatisticsQuality and Editorial ReviewsMentoring Medical WritersProcess Experience

About the role

Key responsibilities & impact

Lead clear and accurate completion of medical writing deliverables
Manage medical writing activities for individual studies and coordinate activities across departments
Lead resolution of client comments
Prepare clinical study protocols and 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
Follow ICH E3 guidelines, standard operating procedures, 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, and listing specifications
Collaborate with clients and data management, biostatistics, regulatory affairs, and medical affairs teams
Conduct 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 project budgets, hours, status, and changes
Complete administrative tasks and other assigned duties

Requirements

What you’ll need

Minimum of 5 years of lead regulatory writing experience
Lead writing experience with Phase 2 and Phase 3 studies
Lead writer experience with protocols, submissions, CTD Modules 2.7.3 and 2.7.4, Clinical Study Reports, Investigator Brochures, Patient Narratives, Briefing Books, ISE, and ISS
Safety Aggregate Reports experience is a plus
Strong project management skills
Strong client experience
Strong time management skills
Process experience is a plus
Must be open to working remotely in the US, UK, or Canada
Equivalent experience, skills, and/or education may be considered

Benefits

Comp & perks

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition and total rewards program
Inclusive culture
Minimal travel required (less than 25%)