Senior Medical Writer – Medical Device & Regulatory Documentation (Remote – USA)
Updated: December 3, 2025
Location: Remote (USA – Oregon)
Job ID: 25103632
Company Overview
Syneos Health is a fully integrated biopharmaceutical solutions organization recognized globally for advancing clinical development, medical affairs and regulatory excellence. With operations in more than 110 countries and a workforce of over 29,000 professionals, the company partners with life sciences organizations to accelerate the delivery of innovative therapies to patients.
Role Overview
Syneos Health is seeking a Senior Medical Writer specializing in Medical Devices and Regulatory Documentation. This remote-based role supports clinical development and regulatory submissions by delivering clear, accurate, and compliant scientific documents. The position requires proven expertise in clinical and regulatory writing, strong cross-functional collaboration, and the ability to lead document strategy and execution with minimal supervision.
Experience Required
Minimum 5–7 years of professional medical writing experience within pharmaceuticals, CROs, biotechnology, or medical devices.
Prior experience supporting regulatory submissions, clinical study documents, and global health authority requirements (e.g., FDA, EMA).
Strong understanding of ICH guidelines, particularly ICH E3 and associated regulatory frameworks.
Experience mentoring junior writers is preferred.
Key Responsibilities
Lead the preparation, writing, and quality review of clinical and regulatory documents, ensuring clarity, accuracy, and scientific integrity.
Develop a wide range of deliverables including:
Clinical study protocols and amendments
Clinical study reports (CSRs)
Investigator brochures
Informed consent forms
Periodic safety update reports (PSURs)
Plain language summaries
IND/NDA and eCTD submission documents
Manuscripts, abstracts, posters, and scientific presentations
Coordinate cross-departmental medical writing activities, ensuring timelines and budgets are met.
Lead client interactions, manage comments, and drive document revisions to completion.
Review statistical analysis plans, tables, figures, and listings for accuracy, consistency, and regulatory appropriateness.
Perform targeted literature research and ensure compliance with copyright requirements.
Mentor less-experienced medical writers and contribute to development of internal work standards and templates.
Support documentation strategy for regulatory engagement, including briefing packages and response documents.
Maintain adherence to company SOPs, client templates, and global regulatory standards.
Complete administrative tasks and support additional duties based on business need.
Occasional travel may be required (less than 25%).
Why Join Syneos Health
Syneos Health fosters a collaborative, growth-oriented environment through:
Career development, skill enhancement, and continuous learning
Supportive leadership and functional mentorship
Competitive compensation, benefits, and professional recognition
A global “Total Self” culture that values authenticity, inclusivity, and diversity
Opportunities to work with leading biopharmaceutical and medical device innovators
Compensation
Salary Range: USD $80,600 – $145,000
Actual compensation depends on qualifications, experience level, and demonstrated competencies. Benefits may include health coverage, dental and vision plans, 401(k) with company match, employee stock purchase plan eligibility, performance bonuses, and flexible paid time off.
About Syneos Health
In the last five years, Syneos Health has collaborated on:
94% of all FDA-approved novel drugs
95% of EMA-authorized therapies
200+ clinical studies across 73,000 sites and more than 675,000 trial participants
The company is committed to advancing global clinical excellence and supporting professionals who thrive in dynamic, competitive environments.
Additional Information
Job responsibilities listed above are not exhaustive and may evolve based on business needs. Equivalent skills and experience may be considered in place of specific educational requirements. Syneos Health complies with global employment, equal opportunity, and disability accommodation regulations.
Summary
The Senior Medical Writer role is integral to developing high-quality scientific and regulatory documentation that supports clinical development and global regulatory strategies. The role requires strong expertise in clinical data interpretation, scientific writing, regulatory compliance, and project leadership.
How to Apply
Click below to submit your application for the Senior Medical Writer position with Syneos Health.
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