Work Flexibility: Remote
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.
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: NoneStryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
