Remote Senior Medical Writer: Clinical Evidence Lead

Stryker; Oregon; Remote; USD 110,000 - 238,000; Full time

Benefits offered by this job

Health benefits including medical, Rx,

Dental and vision insurance

401(k) plan

Employee Stock Purchase Plan (ESPP)

Short-term disability insurance

Job summary

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

The role leads clinical evidence strategies to support regulatory submissions, market access initiatives, and lifecycle decisions, collaborating with Regulatory Affairs, R&D, Clinical, Marketing, and Quality teams. The candidate will author and maintain clinical evaluations, conduct literature reviews, and develop evidence-based recommendations, while mentoring

Qualifications

• Master of Science degree in a health, clinical, biological science, biomedical, engineering, or related 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.

Responsibilities

• 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.

Skills

Medical writing

Regulatory submissions

Literature reviews

Evidence synthesis

Cross-functional collaboration

Education

Master of Science in health/clinical/biomedical field

Minimum 6 years in clinical affairs/regulatory/medical writing

Job description

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

The role leads clinical evidence strategies to support regulatory submissions, market access initiatives, and lifecycle decisions, collaborating with Regulatory Affairs, R&D, Clinical, Marketing, and Quality teams. The candidate will author and maintain clinical evaluations, conduct literature reviews, and develop evidence-based recommendations, while mentoring