Manager, Medical Affairs (Hybrid)
BD (Becton, Dickinson and Company)
**Job Description Summary**
Functional/Organizational Summary
Medical Affairs (MA) has a critical 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.
Position Summary
The Manager, Medical Affairs is responsible for overseeing and managing both the clinical and administrative aspects of the medical division business. This includes: innovation and new product/business development, lifecycle clinical evidence generation, market shaping and development, and safety and compliance. The position may directly or indirectly (matrix) manage 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 creativity 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.
**Job 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.
+ Has accountability for good stewardship of financial resources for personal and project expenses.
+ Innovation: Based on specialized training & clinical operations experience, serves as the internal “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 topics.
+ Evidence generation: For assigned areas of responsibility, serves as the organizational leader responsible for developing & 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 Key Opinion Leaders (KOLs), customer SMEs, and other external collaborators and recommends clinical practices to improve outcomes and patient safety. Includes: support/develop KOL panels and other engagements; 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; ensures medical and clinical claims accuracy. Includes: serving as the Medical Affairs clinical delegate and attending Risk Management Board (RMB) meetings for the assigned product line.
+ Performs other duties and assignments as required.
**Professional Skills & Key Competencies**
+ Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices. This includes analytical problem solving.
+ Demonstrated ability to juggle multiple tasks and to prioritize and schedule work to meet business needs.
+ Demonstrated organizational, planning, and project management skills, including committed, focused vitality, and working towards result.
+ Ability to be effective in complex projects with ambiguity and/or rapid change.
+ Orientation for detailed work product, with emphasis on accuracy and completeness.
**Education Qualifications & Previous Experience:**
+ Required: Nursing degree (BSN).
+ Highly preferred: Advanced degree (MS, MBA, etc.).
+ Required Experience: Enterprise health system with diverse nursing experience spanning multiple practice areas/settings.
+ 7 years practice experience as a Registered Nurse in an enterprise health system organization preferred
+ Highly preferred: Experience directly or indirectly (matrix) engaging/managing 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.
+ Preferred: Ability to apply expertise to improve effectiveness and provide clinical and technical guidance to employees on the team.
+ Required: Conduct literature searches/reviews, design studies per scientific methods, and complete basic statistical analyses on results.
+ Highly preferred: Knowledge of and experience using and interpreting basic biomedical statistical methods.
+ Highly preferred: Experience participating in and/or managing investigational drug or medical device studies, including conducting literature reviews, study design and execution, and compliance monitoring.
+ Required: Experience in continuous process improvement projects and project management.
+ Highly preferred: Prior clinical practice experience with BD product categories.
+ Preferred: Prior people management, ideally in a matrix environment.
+ Preferred: Prior experience with medical product development.
+ Highly preferred: Demonstrated excellent verbal and written communication skills, including the ability to write scientific papers and present at professional conferences.
+ Highly preferred: Work experience with multi-disciplinary/cross-functional teams.
+ Highly preferred: Comfortable working in a position that requires flexibility within a fast paced, multi-task matrixed environment.
**Any Additional Information**
+ Travel may range from 15-25%, overnight travel.
+ BD supports a hybrid work schedule with in office work with fellow associates several days per week, with optional remote work for the balance of the week.
+ Position requires flexible working hours, including some nights and weekends, as needed for support of customer and business activities.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
**Why Join Us?**
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
\#LI-PRO
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**Primary Work Location**
USA CA - San Diego Bldg A&B
**Additional Locations**
USA MD - Sparks - 7 Loveton Circle
**Work Shift**
At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You (https://jobs.bd.com/benefits) .
Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.
**Salary Range Information**
$124,100.00 - $204,800.00 USD Annual
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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