Medical Writer II – Publications

Syneos Health

Medical Writer II responsible for medical writing deliverables at Syneos Health. Leading projects, ensuring clarity and adherence to regulatory standards while collaborating with various stakeholders.

Posted 6/11/2026full-timeRemote • Arizona, Maine, Ohio, Rhode Island • 🇺🇸 United StatesMid-LevelSenior💰 $70,100 - $145,000 per yearWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

medical writingclinical study protocolsclinical study reportspatient narrativesIND submissionsNDA submissionseCTD submissionsstatistical output documentationregulatory standards adherencequality and editorial reviews

Soft Skills

communicationmentoringcollaborationpeer reviewfeedback provisionrelationship buildingclarity in writingorganizational skillsleadershipattention to detail

Tools & Technologies

AMA Manual of Stylestandard operating proceduresclient approved templatesstyle and formatting guides

Industry Keywords

biopharmaceuticalcontract research organizationFDA regulationsICH guidelinesgood publication practicesscientific meetingsclinical development plansannual reportsinvestigator brochuresperiodic safety update reports

About the role

Key responsibilities & impact

Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.
Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports, clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; and abstracts, posters, and presentations for scientific meetings.
Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget.
Coordinates quality and editorial reviews.
Ensures source documentation is managed appropriately.
Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format.
Provides feedback to further define statistical output required and document needs.
Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables.
Mentors and leads less experienced medical writers on complex projects, as necessary.
Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing.

Requirements

What you’ll need

3-5 years of relevant experience in science, technical, or medical writing
Experience working in the biopharmaceutical, device, or contract research organization industry required
Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required
Experience writing relevant document types required
Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style

Benefits

Comp & perks

Health benefits to include Medical, Dental and Vision
Company match 401k
Eligibility to participate in Employee Stock Purchase Plan
Eligibility to earn commissions/bonus based on company and individual performance
Flexible paid time off (PTO) and sick time