Senior Manager, Medical Affairs (Remote)
Michigan, Virtual Address, United States
Stryker is hiring a Senior Manager, Medical Affairs, this position is Remote, supporting our Instruments Division.
What you will do
Provide leadership and subject matter expertise to managing clinical studies including project planning, budget, resource management and contract research organization management. Oversees clinical trial staff and manages all aspects of clinical operational plans. You are responsible for managing full scope of study, protocol and scientific publications. Acting as a cross functional liaison to ensure study plan aligns with business with business development strategies.
- Lead medical affairs team and initiatives related to regulatory submissions, clinical evaluations, post-market surveillance, and quality processes.
- Partner closely with Regulatory, Quality, and Clinical Research teams to ensure medical and scientific accuracy, compliance, and alignment with divisional goals.
- Represent Medical Affairs in internal and external regulatory and quality discussions, providing expert medical and scientific insights.
- Develop and implement a strategic scientific communications framework to elevate Stryker’s presence in key therapeutic areas.
- Drive the creation of peer-reviewed publications, white papers, abstracts, and conference presentations to showcase the company’s clinical and scientific excellence.
- Lead the development of scientific messaging and ensure consistency across internal and external communication materials.
- Scale and lead a team of clinical evaluation specialists to establish best-in-class capabilities.
- Develop and implement training programs to enhance internal team capabilities in medical writing, scientific data interpretation, and effective communication.
- Drive continuous improvement within the Medical Affairs team, identifying opportunities for process optimization and innovation.
- Provide medical input and guidance on product development, risk management, and evidence generation strategies to support product lifecycle management.
- Collaborate with external Key Opinion Leaders (KOLs), medical societies, and professional organizations to build relationships and drive scientific engagement.
What you will need
- Bachelor of Science, engineering or related Advanced degree.
- Minimum of 10 years of experience in regulatory and quality-related medical affairs activities, including clinical evaluation and post-market surveillance.
- Demonstrated expertise in scientific communications, including medical writing, publication strategy, and external scientific engagement.
Preferred
- Strong leadership experience with a history of building and mentoring high-performing teams.
- Strong knowledge of global regulatory requirements, clinical trial processes, and medical device regulations (e.g., MDR, FDA).
- Excellent project management, problem-solving, and strategic-thinking skills.
- $129,600.00 - 220,400.00 USD Annual salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.
Job Profile
Remote
Benefits/PerksBenefits Bonus Bonus eligible Bonus eligible + benefits Equal opportunity employer Flexibility Salary plus bonus eligible + benefits Training programs Travel Percentage Work flexibility
Tasks- Build relationships
- Development
- Develop scientific communications
- Drive continuous improvement
- Drive peer-reviewed publications
- Enhance team capabilities
- Lead clinical studies
- Manage clinical trial staff
- Oversee regulatory submissions
- Risk Management
- Training
Access Budget management Business Development Clinical evaluation Clinical evaluations Clinical Research Clinical Studies Clinical Trial Management Communication Compensation Compliance Continuous Improvement Contract Research Organization Management Data interpretation Effective Communication Engineering Evidence Generation FDA Flexibility Functions Global Regulatory Requirements Leadership M Medical Affairs Medical device Medical Device Regulations Medical Writing Mentoring Messaging Operational Organization Post market surveillance Problem-solving Process Optimization Product Development Product Lifecycle Product lifecycle management Project Management Project Planning Publication strategy Quality processes Regulatory requirements Regulatory Submissions Research Resource Management Risk Management Scientific Communications Strategic Strategic Thinking Team Leadership Teams Training
Experience10 years
EducationAdvanced degree Bachelor of Science Business Engineering Research Science Scientific
TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9