JOB DESCRIPTION SUMMARY

As Manager, Medical Affairs, you will be responsible for both the clinical and administrative aspects of MMS business. This includes innovation and new product/business development, lifecycle clinical evidence generation, market shaping, and safety and compliance. This role will heavily focus on medical safety and compliance. Candidates will be required to report to a BD office 4 days per week.

JOB DESCRIPTION

We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

QUALIFICATIONS

Education

• Minimum: Pharmacy Degree (PharmD) or Bachelors in Nursing (BSN). Advanced degree preferred.

Licensures

• PharmD and US pharmacist licensure required OR BSN and US nursing licensure required.

Experience

• Minimum 7 years hospital experience. Additional experience within medication or patient safety, quality, regulatory affairs, or medical devices desired

Knowledge and Skills

• Demonstrated experience conducting literature searches/reviews, design studies per scientific methods, and basic statistical analysis results.
• Proven continuous process improvement project planning and management expertise, including a results-orientation and ability to work independently on multiple projects.
• Experience directly or indirectly (matrix) engaging vendors, cross-functional project team members, and medical process/program management/ownership is preferred. Employee coaching, mentorship, and supervision of support and professional associates is preferred.
• Knowledge and experience using and interpreting basic biomedical statistical methods is preferred.
• Experience participating in and/or leading investigational drug or medical device studies; including conducting literature reviews, study design and execution, and compliance monitoring.

• Develops processes and procedures to implement Medical Affairs strategies, including the execution of business operating plans.
• Maintains good stewardship of financial resources for project expenses.
• Serves as the internal “Voice of the End User” to ensure product releases to market are safe and effective; includes Core Team representation, Extended Core Team leadership for medical workstreams, and provides subject matter expertise (SME) input to Research & Development (R&D)/User Experience Design (UXD) on clinical operations and outcomes topics.
• Develops and leads evidence generation activities, prepares publication and dissemination strategy, and ensures clinical trial excellence including study protocol development, evidence project execution, and study result presentations at leadership and external professional meetings.
• Engages Key Opinion Leaders (KOLs), customer SMEs, and other external collaborators and recommends clinical practices to improve outcomes and patient safety including supporting/developing KOL panels and other engagements; supports implementation of evidence for customer-facing materials and engagements.
• Supports activities ensuring safety and compliance throughout product lifecycle; reinforces enterprise-wide medical policies and procedures; ensures compliance and is a Medical Affairs clinical delegate on the Risk Management Board.