Senior Medical Writer

Syneos Health

. Lead clear and accurate completion of medical writing deliverables .

Posted 10/7/2026full-timeRemote • IndiaSeniorWebsite

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 lead teams, mentor junior writers, and collaborate effectively across departments in the biopharmaceutical industry.

Highest-signal resume keywords

Medical WritingClinical Study ProtocolsRegulatory SubmissionsFDA RegulationsICH Guidelines

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study ReportsPatient NarrativesInformed ConsentsStatistical Analysis PlansProtocol AmendmentsNDA SubmissionsECTD SubmissionsPlain Language SummariesIntegrated Summary ReportsJournal Manuscripts

Soft Skills

Clear CommunicationMentoringCollaborationProblem SolvingTechnical Support

Tools & Technologies

AMA Manual of StyleSource DocumentationQuality Review Processes

Industry Keywords

BiopharmaceuticalContract Research OrganizationPK/PD StudiesPhase II StudiesPhase III Studies

About the role

Key responsibilities & impact

Lead clear and accurate completion of medical writing deliverables
Manage medical writing activities for individual studies and coordinate 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, templates, authorship requirements, and style guides
Coordinate quality and editorial reviews and manage source documentation
Lead team document reviews and perform peer reviews
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
Complete administrative tasks and other assigned duties

Requirements

What you’ll need

Minimum 4 to 5 years of experience in medical writing
3–5 years of relevant experience in science, technical, or medical writing
Experience working in the biopharmaceutical, device, or contract research organization industry
Experience working with PK/PD studies, CSR, IB, ICF, and protocols
Experience with Phase II/Phase III studies and readiness to work in Early Phase
Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices
Experience writing relevant document types
Extensive knowledge of English grammar and ability to communicate clearly
Strong familiarity with AMA Manual of Style
Ability to work within budgeted hours and communicate status and changes to medical writing leadership
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 and total rewards program
Inclusive culture
Minimal travel may be required (less than 25%)