- Salary
- $110k – $183k
- Location
- Colorado, Denver Surrounding Virtual Address, United States of America · Seattle, Washington · Portland, Oregon · San Diego, California · Phoenix, Arizona · Los Angeles, California
- Type
- Full-time
- Department
- Healthcare
- Seniority
- Senior
- Experience
- 6+ years
- Education
- PhD
- Source
- Workday
Description
Stryker is hiring a Senior Staff Medical Writer to join our Endoscopy Division, to be based remotely anywhere within the United States. Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. Our Endoscopy Division delivers a diverse array of innovative medical technologies to support minimal invasive surgery through brilliant visualization, connected OR solutions, sports medicine products to sustainability solutions.
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
Travel Percentage: 10%Stryker 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.
