Senior Medical Writer – Regulatory

Syneos Health

Medical Writer managing the development of medical writing deliverables and coordinating activities for clinical studies. Responsibilities include document preparation, regulatory adherence, and mentoring junior writers.

Posted 7/23/2026full-timeRemote • Maryland • 🇺🇸 United StatesSenior💰 $80,600 - $175,700 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in medical writing, ensuring compliance with regulatory standards and guidelines while producing high-quality scientific documents. Capable of mentoring and leading teams, coordinating cross-departmental activities, and maintaining strong client relationships.

Highest-signal resume keywords

Medical Writing DeliverablesICH E3 GuidelinesClinical Study ProtocolsRegulatory SubmissionsPeer Review

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study ReportsPatient NarrativesAnnual ReportsInvestigator BrochuresInformed ConsentsPlain Language SummariesPeriodic Safety Update ReportsIND SubmissionsNDA SubmissionsECTD Submissions

Soft Skills

Interpersonal CommunicationMentoringProblem SolvingCollaborationQuality Assurance

Industry Keywords

Regulatory RequirementsCopyright ComplianceStatistical Analysis PlansEditorial ReviewsScientific Meetings

About the role

Key responsibilities & impact

Manage medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision
Completes required administrative tasks within the specified timeframes
Performs online clinical literature searches and complies with copyright requirements
Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing
Minimal travel may be required (less than 25%)

Requirements

What you’ll need

Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately
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
Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format
Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency
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
Identifies and proposes solutions to resolve issues
Mentors and leads less experienced medical writers on complex projects, as necessary

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