Stryker is seeking a Staff Medical Writer to join its Sports Medicine Business Unit, part of the Stryker Endoscopy Division. This role involves collaborating closely with cross-functional teams to ensure the successful preparation of high-quality, submission-ready clinical documents.
Job Type
- Full-time
Location
- Remote (United States)
Role of the Job
The Staff Medical Writer will be responsible for developing and completing Clinical Evaluation Reports (CERs) and post-market clinical follow-up (PMCF) documents for new medical devices to support product registrations internationally. This role requires strong scientific and medical writing skills, as well as the ability to work independently and collaboratively with cross-functional teams.
Main Responsibilities
- Prepare high-quality, submission-ready clinical documents to support product registrations internationally.
- Perform literature reviews for medical device groups or sub-groups and synthesize the information in clinical regulatory documents.
- Lead discussions on document revision and resolve issues related to EU clinical documents.
- Provide input for design teams for Clinical EU MDR documentation and assist with Clinical Evaluation Strategy for EU Market access.
- Coordinate and manage the review process for clinical documents and lead discussions on document revision.
Qualification Needed
- Bachelor’s degree (BA or BS) in a technical and/or scientific discipline required.
- 4+ years of Industry experience in medical technology or pharmaceuticals, along with 2+ years of experience in Scientific or Medical Writing.
- Master’s or Ph.D. or other higher degree in health-related field (RN, BSN, BPharm/MD/MPH) is highly preferred.
- Understanding and experience in the use of scientific journals, publication guidelines, databases, search strategies, literature management software.
- Knowledge and experience with MEDDEV 2.7/1 Rev. 4, EU Medical Device Regulation 2017/745 (MDR) and MDCG compliant clinical evaluations and clinical study documents.
FAQs
What benefits does this role offer?
Opportunity to work with a leading medical technology company and contribute to the development of high-quality clinical documents.
Is previous experience in medical writing required?
Yes, experience in medical writing or scientific writing is required.
Can I work remotely?
Yes, this role offers remote work arrangement with flexible working hours.
What kind of support will I receive?
Comprehensive training and support from experienced team members.
Are there opportunities for growth and development?
Yes, opportunities for career growth and professional development are available.
What kind of company culture can I expect?
A culture of innovation, teamwork, and passion for improving patient outcomes.
How is the company structured?
Stryker is a leading medical technology company with a diverse range of products and services.
What kind of work-life balance can I expect?
Flexible working hours and remote work arrangement support work-life balance.
Is Stryker an equal opportunity employer?
Yes, Stryker is an equal opportunity employer and welcomes applications from diverse candidates.
What tools will I be using?
Various medical writing and project management tools, including those for clinical document development and management.
Salary Package
Competitive salary: A competitive salary package with opportunities for bonuses and career advancement.
Benefits: Comprehensive benefits package, including health insurance, retirement plans, and paid time off.
Salary range: $87,600.00 – $186,700.00 per year, plus bonus eligible and benefits.
Required Documents
- CV
- Resume
APPLY HERE
About Stryker
Stryker is a leading medical technology company that develops innovative products and services to improve patient outcomes. With a diverse range of products and services, Stryker is committed to advancing medical technology and improving patient care.
Stryker’s mission is to help people live better lives by advancing medical technology and improving patient outcomes. The company’s values include innovation, teamwork, and a passion for improving patient care.