Senior Medical Writer – Regulatory Submission Documents

Syneos Health

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

Posted 11/3/2026full-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 adhering to FDA and ICH guidelines. Capable of leading cross-departmental collaboration and mentoring less experienced writers on complex projects.

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 NarrativesIND SubmissionsNDA SubmissionsStatistical Analysis PlansDocument ReviewsTechnical SupportRegulatory GuidelinesPublication Practices

Soft Skills

Clear CommunicationMentoringProblem SolvingCollaborationAttention to Detail

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 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
Follow 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 teams in data management, biostatistics, regulatory affairs, and medical affairs
Perform online clinical literature searches and comply with copyright requirements
Identify and propose solutions, escalating issues 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 affecting medical writing
Work within 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 medical writing, including proven Protocol writing experience
Experience working in the biopharmaceutical, device, or contract research organization industry
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
Experience writing relevant document types
Experience 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%)
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
Minimal travel requirement (less than 25%)