Job Description Summary

Medical Affairs (MA) plays a significant role in new product development to include Key Opinion Leader engagement on innovative technologies; user needs, requirements, and hazards, all to ensure product safety and efficacy. MA also plays a large role in the development of post market risk estimation criteria, risk benefit analysis of products, Clinical Evaluation Reports and literature searches.
The Sr Manager, Medical Affairs is responsible for overseeing and managing both the clinical and administrative aspects of the medical division of business. This includes: innovation and new product/business development, lifecycle clinical evidence generation, market shaping and development, and safety and compliance for both regulated and non-regulated devices. The position may directly or indirectly (matrix) manage supervisors, professional employees, business support, or technical staff.

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. 

Key Responsibilities

• Develops processes and procedures to implement Medical Affairs strategies, including the execution of business operating plans.

• Accountable for setting own work direction and completing work tasks assigned by leadership team.

• Directly or indirectly (matrix) handles vendors, cross-functional project team members, and has medical process/program management/ownership.  This includes project leadership, employee coaching, mentorship, and supervision of support and entry-level professional associates.

• Applies expertise to improve effectiveness and provide clinical and technical guidance to employees on the team. 

• Has accountability for good stewardship of financial resources for personal and project expenses.

• Provides cross-regional support for medical activities, including global businesses.

• Innovation: Serves as the “Voice of the End User” to help ensure that products released 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.

• Evidence generation: Serves as a leader for building & supervising evidence generation activities, leading publication and dissemination strategy, and ensuring clinical trial excellence.  Includes: study protocol development, evidence project execution, and presentation of study results at internal leadership and external professional meetings.

• Market-shaping: Engages and influences Key Opinion Leaders (KOLs) and other external partners, influences clinical practice to improve outcomes, and drives appropriate global product adoption.  Includes: support/develop KOL panels and other engagements, and support implementation of evidence for customer-facing materials and engagements.

• Safety and compliance: supports activities ensuring safety and compliance throughout product lifecycles, supports enterprise-wide medical policies and procedures, and ensures medical and clinical claims' accuracy.  Includes: serving as the Medical Affairs clinical delegate, attending Risk Management Board (RMB) meetings for the assigned product line; provide clinical input for RMB risk assessments: designation of hazardous situation severity; description of clinical workflow and assessment of situation and outcome probability; timely formal review and approval of RMB risk assessments for assigned product line.  Provide input into product hazard analyses (HA): serve as the Independent Clinical Reviewer for final hazard analysis reviews; help to ensure validity and completeness of hazard analysis efforts; timely formal review and approval of HAs for the assigned product line.

• Performs other duties and assignments as required.

Professional Skills & Key Competencies

• Knowledge of and experience using and interpreting basic biomedical statistical methods.

• Conduct literature searches/reviews, design studies per scientific methods, and complete basic statistical analyses on results.