Principal Medical Writer – Regulatory

Syneos Health

Principal Medical Writer creating clinical and regulatory documents for Syneos Health, a biopharmaceutical services organization. Coordinating reviews, client comments, regulatory standards, budgets, and medical writing teams.

Posted 8/7/2026full-timeRemote • 🇨🇦 CanadaLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in medical writing, including the completion of clinical and regulatory documents while adhering to ICH E3 guidelines and company SOPs. Proven ability to mentor and lead teams, manage project budgets, and provide technical support and training.

Highest-signal resume keywords

Medical Writing DeliverablesICH E3 GuidelinesClinical Study ReportsStatistical Analysis PlansRegulatory Requirements

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study ReportsPatient NarrativesInformed ConsentsIND SubmissionsNDA SubmissionsECTD SubmissionsStatistical Analysis PlansOnline Clinical Literature SearchesDocument ReviewsBudget Management

Soft Skills

MentoringTeam LeadershipClient Relationship BuildingProblem SolvingCommunication

Industry Keywords

Medical WritingRegulatory AffairsBiostatisticsClinical Development PlansCopyright Compliance

About the role

Key responsibilities & impact

Lead the clear and accurate completion of medical writing deliverables and coordinate medical writing activities across departments.
Lead resolution of client comments.
Complete clinical and regulatory documents, including protocols, clinical study reports, patient narratives, investigator brochures, informed consents, plain language summaries, safety reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, manuscripts, abstracts, posters, and presentations.
Follow ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style and formatting guides.
Coordinate quality and editorial reviews; manage source documentation appropriately.
Lead team document reviews and act as a peer reviewer.
Review statistical analysis plans and table/figure/listing specifications, providing feedback on statistical outputs and document needs.
Build working relationships with clients and data management, biostatistics, regulatory affairs, and medical affairs teams.
Perform online clinical literature searches and comply with copyright requirements.
Identify and propose solutions to issues, escalating as appropriate.
Provide technical support, training, and consultation to staff.
Mentor and lead less experienced medical writers on complex projects.
Develop expertise in industry topics and regulatory requirements affecting medical writing.
Monitor assigned project budgets and communicate status or changes to medical writing leadership.
Complete required administrative tasks and other assigned duties.

Requirements

What you’ll need

Experience, skills, and/or education equivalent to the qualifications determined by the company may be considered.
Adherence to ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style and formatting guides.
Ability to review statistical analysis plans and table/figure/listing specifications.
Ability to perform online clinical literature searches and comply with copyright requirements.
Ability to work within budgeted hours and communicate project status and changes.
Ability to provide technical support, training, and consultation.
Ability to mentor and lead less experienced medical writers on complex projects.
Ability to develop expertise in regulatory requirements and guidelines affecting medical writing.
Minimal travel may be required (less than 25%).

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
Comprehensive resources including emerging technologies, data, science and knowledge sharing
Minimal travel may be required (less than 25%)