Senior Staff Medical Writer (Remote)

Stryker

Oregon

Remote

USD 110,000 - 238,000

Full time

4 days ago
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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 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.Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

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