Stryker Corporation

Senior Staff Medical Writer (Remote)

Stryker Corporation$110K — $238K *
US-AnywhereRemote in Denver, CO
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a scientific or technical field.
  • 6+ years in medical technology or healthcare industry.
  • 4+ years in medical writing or regulatory documentation activities.
  • Proven experience with Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-Up (PMCF) documents.
  • Expert knowledge of EU medical device regulations and associated guidance.
  • Experience with systematic literature reviews and scientific databases.
  • Familiarity with FDA regulations and international medical device standards.

Responsibilities

  • Author and maintain essential clinical documentation for regulatory compliance.
  • Compile and synthesize clinical evidence into submission-ready documents.
  • Address regulatory feedback to facilitate market access.
  • Develop evidence strategies and document plans with cross-functional teams.
  • Draft protocols, reports, and scientific documents for clinical initiatives.
  • Conduct literature reviews and evaluate scientific data for documentation.
  • Lead review cycles, coordinating feedback and obtaining necessary approvals.

Benefits

  • Remote work flexibility.
  • Opportunity to mentor junior team members.
  • Involvement with cross-functional teams across various stages of product lifecycle.
Full Job Description
Work Flexibility: Remote

As the Senior Staff Medical Writer, you will develop scientific and clinical documentation that supports global regulatory compliance and market access for medical devices. This position partners closely with Regulatory Affairs, Clinical Affairs, Quality, Research & Development, and Marketing teams to translate complex clinical evidence into high-quality regulatory and scientific documents throughout the product lifecycle.

What You Will Do
  • Author and maintain Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) documents, and other clinical evidence documentation supporting international product registrations and lifecycle management.
  • Compile, analyze, and synthesize clinical evidence from clinical studies, published literature, post-market data, and other safety and performance sources into submission-ready regulatory documents.
  • Respond to notified body reviews and regulatory feedback, driving resolution of clinical documentation questions to support ongoing market access.
  • Collaborate with cross-functional teams to develop clinical evidence strategies, regulatory documentation plans, and project timelines.
  • Author clinical study protocols, study reports, data summaries, and supporting scientific documents for regulatory and clinical initiatives.
  • Conduct systematic literature reviews, evaluate scientific data, and integrate findings into clinical and regulatory documentation.
  • Lead document review cycles, coordinate stakeholder feedback, resolve content issues, and obtain timely approvals.
  • Drive continuous improvement initiatives, maintain medical writing tools and templates, and mentor junior medical writing team members.


What You Need

Required
  • Bachelor's degree in a scientific, technical, healthcare, or related discipline.
  • Minimum 6 years of industry experience within medical technology, medical devices, pharmaceuticals, or healthcare products.
  • Minimum 4 years of experience in scientific writing, medical writing, clinical research, or related regulatory documentation activities.
  • Experience authoring Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-Up (PMCF) documentation.
  • Expert knowledge of MEDDEV 2.7/1 Rev. 4, European Union Medical Device Regulation (EU MDR 2017/745), and Medical Device Coordination Group (MDCG) guidance for clinical evaluations.
  • Experience conducting systematic literature reviews and utilizing scientific databases, literature search methodologies, and literature management tools.
  • Knowledge of FDA, Good Clinical Practice (GCP), ISO 14155, ISO 14971, and applicable international medical device regulations and standards.


Preferred
  • Master's degree, PhD, PharmD, MD, MPH, RN, BSN, or other advanced health-related degree.
  • Experience authoring clinical study protocols, clinical study reports, manuscripts, or scientific publications.
  • Experience supporting regulatory submissions and global market access initiatives for medical devices.
  • Knowledge of clinical operations, risk management, and international regulatory requirements.


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.

Travel Percentage: 10%

About Stryker Corporation

Stryker Networks is a premier Information Technology partner providing IT managed services and database application development.

Stryker Corporation Careers

Joining Stryker Corporation means becoming part of a global team recognized for its commitment to innovation, leadership, and enhancing patient outcomes. As a leading medical technology company, Stryker is the perfect place to build a career that truly makes a difference.

Work You’ll Do

At Stryker, every position contributes to our mission of making healthcare better. Here, you will use your skills to work on transformative projects that improve lives across the globe. You will be part of a culture that thrives on growth, innovation, and leadership, and you will work alongside some of the brightest minds in the industry.

Innovative Careers

Stryker offers a range of job opportunities, from internships that provide a stepping stone into high-impact roles to leadership positions that drive strategic direction. Our team members benefit from a work environment that supports professional growth and diversity training, ensuring everyone, regardless of background, can thrive.

Be Part of a Great Team

Our employees enjoy a collaborative atmosphere that fosters innovation and encourages professional development. With a commitment to leadership and diversity, Stryker ensures that all team members have the opportunity to grow and influence the company's future. Our global scale and dedication to impactful solutions make us leaders in medical technology.

Future-Proof Your Career

Stryker is dedicated to career development, offering extensive training, benefits, and resources to help you advance professionally. From networking opportunities to workshops on resume and interview skills, we support your journey every step of the way. Our career paths are as diverse as the innovative products we develop and the markets we serve.

Explore Job Opportunities

Whether you’re just starting out or looking to take your career to the next level, Stryker provides the tools and resources to achieve your goals. We are continuously hiring and looking for ambitious, curious, and driven individuals to join our team.

Stryker Corporation – A Leader in Medical Technology

Our commitment to improving healthcare through innovative products sets us apart in the medical technology field. The synergy of our team’s expertise and our leadership in technology solutions enables us to meet the needs of our customers effectively.

Stay Connected

Join Our Team Search open positions that match your skills and interest. We look for passionate, creative, and solution-driven team players. Explore the many benefits of employment at Stryker, a company that values innovation and leadership.

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Stryker Corporation – Where Talent Meets Opportunity

At Stryker, we believe in turning the challenges of today into the breakthroughs of tomorrow. Join us in our mission to improve healthcare around the world.
Learn more about Stryker Corporation
Size
46,000 employees
Market Cap
$91.9 billion
Industry
Net Income
$1.5 billion
Founded
2004
5 Year Trend
+8.6%
Revenue
$14.3 billion
NASDAQ

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