Sponsor Dedicated Protocol Medical Writer II/Sr

Syneos Health

. Partner closely with Clinical Scientists on protocols and protocol amendments .

Posted 9/30/2026full-timeRemote • Canada, United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in medical writing, including protocol writing and regulatory submissions, while ensuring compliance with FDA and ICH regulations. Capable of leading cross-departmental collaboration and mentoring less experienced writers.

Highest-signal resume keywords

Medical WritingProtocol WritingFDA RegulationsICH GuidelinesVeeva/CARA

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study ProtocolsClinical Study ReportsPatient NarrativesAnnual ReportsInvestigator BrochuresInformed ConsentsECTD SubmissionsStatistical Analysis PlansDocument ReviewsRegulatory Submissions

Soft Skills

Clear CommunicationMentoringProblem SolvingCollaborationTechnical Support

Tools & Technologies

VeevaCARA

Industry Keywords

BiopharmaceuticalOncologyHematologyCell TherapyContract Research Organization

About the role

Key responsibilities & impact

Partner closely with Clinical Scientists on protocols and protocol amendments
Lead clear and accurate completion of medical writing deliverables
Manage medical writing activities for individual studies with minimal supervision
Coordinate medical writing activities across departments
Lead resolution of client comments
Write 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, company SOPs, client standards, approved templates, authorship requirements, and style guides
Coordinate quality and editorial reviews and manage source documentation
Lead team document reviews and act as an internal 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
Mentor and lead less experienced medical writers
Develop expertise in industry topics and regulatory requirements
Monitor budgeted hours and communicate status and changes to medical writing leadership
Complete required administrative tasks and other assigned duties

Requirements

What you’ll need

3-5 years of relevant experience in medical writing, with proven experience in Protocol writing
Experience working in the biopharmaceutical, device, or contract research organization industry required
Experience with late development
Experience with Oncology/Hematology/Cell therapy
Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required
Experience writing relevant document types required
Experience in working with Veeva/CARA
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%)

Benefits

Comp & perks

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