Senior Medical Writer, Publications

Syneos Health

. Lead clear and accurate completion of medical writing deliverables .

Posted 9/23/2026full-timeRemote • United StatesSenior💰 $80,600 - $175,700 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in medical writing and clinical research documentation, with a strong ability to lead deliverables, coordinate cross-departmental activities, and adhere to regulatory standards. Proficient in mentoring less experienced writers and managing project budgets while ensuring high-quality outputs.

Highest-signal resume keywords

Medical Writing ExpertiseClinical Research DocumentationICH E3 Guidelines KnowledgeStatistical Analysis Plan ReviewQuality and Editorial Review Coordination

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Medical WritingClinical Study ProtocolsClinical Study ReportsIND SubmissionsNDA SubmissionsECTD SubmissionsStatistical Analysis PlansOnline Clinical Literature SearchesRegulatory StandardsSOPs

Soft Skills

LeadershipMentoringProblem SolvingCollaborationCommunication

Industry Keywords

Regulatory RequirementsAuthorship RequirementsStyle and Formatting GuidesClient StandardsBudget Management

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
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 scientific meeting presentations
Adhere to regulatory standards, 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 an internal peer reviewer
Review statistical analysis plans and table/figure/listing specifications
Collaborate with clients and colleagues in data management, biostatistics, regulatory affairs, and medical affairs
Perform online clinical literature searches
Identify and propose solutions, escalating issues as appropriate
Provide technical support, training, and consultation
Contribute to internal materials, presentations, processes, standard practices, and capabilities
Mentor and lead less experienced medical writers on complex projects
Develop expertise in industry topics and regulatory requirements
Monitor project budgets and communicate status and changes to medical writing leadership
Complete administrative tasks and other assigned duties
Travel minimally, if required

Requirements

What you’ll need

Experience and deep expertise in medical writing and clinical research documentation
Ability to lead medical writing deliverables with minimal supervision
Knowledge of ICH E3 guidelines, regulatory standards, SOPs, client standards, templates, authorship requirements, and style and formatting guides
Ability to coordinate quality and editorial reviews
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 identify and resolve issues and provide technical support, training, and consultation
Ability to mentor and lead less experienced medical writers
Deep expertise in relevant industry topics and regulatory requirements and guidelines
Ability to work within budgeted hours and communicate status and changes
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 and total rewards program
Inclusive culture
Company car or car allowance
Medical, dental, and vision health benefits
Company match 401(k)
Eligibility to participate in Employee Stock Purchase Plan
Eligibility to earn commissions/bonus based on company and individual performance
Flexible paid time off (PTO)
Sick time
Reasonable accommodations, when appropriate