Senior Staff Medical Writer (Remote)

Stryker; Fremont (CA); Remote; USD 110,000 - 238,000; Full time

Job summary

Stryker is seeking a Senior Staff Medical Writer in the Neurovascular Division for a remote position in the United States. You will lead the development of clinical evidence strategies and scientific documentation to support regulatory submissions, market access initiatives, and product lifecycle decisions.

The role partners with Regulatory Affairs, R&D, Clinical, Marketing, and Quality to ensure evidence is effectively evaluated, communicated, and applied across the product lifecycle.

Qualifications

• Master's degree in a health or science field required.
• 6+ years in clinical affairs, regulatory, quality, medical writing, or related field.

Responsibilities

• Lead the development and execution of clinical evidence strategies for product development and lifecycle management.
• Manage clinical evaluation projects aligning clinical evidence with regulatory strategy and commercialization objectives.
• Author and maintain clinical evaluations, post-market documentation, regulatory submissions, and annual reports.
• Design and execute systematic literature reviews, evaluate evidence, and synthesize data into supported conclusions.
• Assess benefit-risk profiles and develop evidence-based recommendations per global regulatory requirements.
• Partner with regulatory authorities and internal stakeholders to address clinical evidence requirements for submissions.
• Develop scientific communications including manuscripts, abstracts, presentations, and customer-facing materials.
• Mentor team members and improve evaluation methodologies and processes.

Skills

Medical writing

Regulatory affairs

Clinical evaluation

Evidence synthesis

Education

Master of Science degree in a health/science field

Doctoral degree (PhD, PharmD, MD)

Job description

Stryker is hiring a Senior Staff Medical Writer for our Neurovascular Division. This is a remote position within the United States.

As the Senior Staff Medical Writer, you will lead the development of clinical evidence strategies and scientific documentation that support regulatory submissions, market access initiatives, and product lifecycle decisions. This position partners closely with Regulatory Affairs, Research and Development, Clinical, Marketing, and Quality teams to ensure clinical evidence is effectively evaluated, communicated, and applied throughout the product lifecycle.

What You Will Do

• Lead the development and execution of clinical evidence strategies for new product development and lifecycle management activities.
• Manage clinical evaluation projects, ensuring alignment between clinical evidence, regulatory strategy, product claims, and commercialization objectives.
• Author and maintain clinical evaluations, post-market clinical follow-up documentation, regulatory submissions, annual reports, and other clinical documentation.
• Design and execute systematic literature reviews, evaluate published evidence, and synthesize clinical, preclinical, and post-market data into scientifically supported conclusions.
• Assess benefit-risk profiles of medical devices and develop evidence-based recommendations in accordance with global regulatory requirements.
• Partner with regulatory authorities and internal stakeholders to address clinical evidence requirements and support regulatory submissions.
• Develop scientific communications, including manuscripts, conference abstracts, presentations, white papers, and customer-facing evidence materials.
• Mentor team members, lead cross-functional review processes, and identify opportunities to improve clinical evaluation methodologies, documentation practices, and team efficiency.

What You Need

Required

• Master of Science degree in a health, clinical, biological science, biomedical, engineering, or related scientific field.
• Minimum 6 years of experience in clinical affairs, regulatory affairs, quality, medical writing, clinical evaluation, post-market surveillance, or related field.
• Minimum 2 years of experience authoring clinical evaluations for medical devices.
• Experience conducting literature reviews, evidence synthesis, and scientific analysis using clinical and/or technical data.
• Experience supporting regulatory submissions and product lifecycle activities within a regulated healthcare industry.

Preferred

• Doctoral degree (PhD, PharmD, MD, or equivalent) in a health or science-related discipline.
• Experience supporting global medical device regulatory requirements, including clinical evaluation, post-market clinical follow up, and market access activities.
• Experience applying global regulatory requirements, including ISO, FDA, and international regulations
• Experience managing complex cross-functional projects within the medical device industry.

Posted Date: 11/04/2026 This role will be posted for a minimum of 3 days.

United States of America Pay Ranges:

• USN: $110,100 - $183,400 USD Annual
• US5: $115,600 - $192,600 USD Annual
• US10: $121,100 - $201,700 USD Annual
• US15: $126,600 - $210,900 USD Annual
• US20: $132,100 - $220,100 USD Annual
• US30: $143,100 - $238,400 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.