Sponsor Dedicated Medical Writer II/Sr

Syneos Health

Medical writer leading clinical, regulatory, and scientific documents for Syneos Health, a life sciences services organization. Collaborating with biopharmaceutical clients and cross-functional clinical teams.

Posted 8/8/2026full-timeRemote • 🇵🇹 PortugalSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in medical writing, including the completion of clinical, regulatory, safety, publication, and submission documents while adhering to ICH E3 guidelines and regulatory standards. Proven ability to lead document reviews, mentor junior writers, and effectively communicate with cross-functional teams.

Highest-signal resume keywords

Medical WritingRegulatory StandardsFDA RegulationsICH GuidelinesAMA Manual of Style

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Document WritingRegulatory Document WritingStatistical Analysis Plan ReviewSource Documentation ManagementTechnical SupportLiterature SearchQuality Review CoordinationDocument Review LeadershipPublication PracticesBudget Management

Soft Skills

Clear CommunicationMentoringProblem SolvingCollaborationTime Management

Industry Keywords

BiopharmaceuticalMedical DeviceContract Research OrganizationGood Publication PracticesCross-Functional Team Interaction

About the role

Key responsibilities & impact

Lead the clear and accurate completion of medical writing deliverables
Manage medical writing activities associated with individual studies
Coordinate medical writing activities within and across departments with minimal supervision
Lead resolution of client comments
Complete clinical, regulatory, safety, publication, and submission documents
Adhere to regulatory standards, ICH E3 guidelines, company SOPs, client standards, templates, authorship requirements, and style 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
Interact with clients and cross-functional teams in data management, biostatistics, regulatory affairs, and medical affairs
Perform online clinical literature searches and comply with copyright requirements
Identify and propose solutions to resolve issues
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
Work within 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 science, technical, or medical writing
Experience in the biopharmaceutical, medical device, or contract research organization industry required
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
Ability to communicate clearly
Strong familiarity with AMA Manual of Style
Ability to work within budgeted hours and specified timeframes
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
Minimal travel may be required (less than 25%)
Comprehensive resources including emerging technologies, data, science and knowledge sharing
Career paths and employment opportunities
Collaborate with passionate problem solvers
Partner with the most diverse team of experts in the industry