Medical Affairs, Senior Manager

BD; Franklin Lakes (NJ); On-site; USD 172,000 - 275,000; Full time

Benefits offered by this job

Health benefits

401(k) Plan

Paid time off

Dental coverage

Job summary

BD is a leading global medical technology company. We are seeking an experienced leader for Program/Clinical Trial activities based in Franklin Lakes, NJ, onsite daily.

The role involves directing EP ASCP/ASVP staff, hiring and managing personnel, ensuring regulatory compliance, and coordinating with IRB/EC and project teams. Ideal candidates have a clinical background (RN/PA/NP), a science degree, 5+ years in clinical trials, and strong program management experience.

Qualifications

• Licensed Healthcare Practitioner (RN/PA/NP) with a science degree
• Minimum 5 years in human clinical trials, GCP experience preferred
• Minimum 5 years in Program Management and people management

Responsibilities

• Provide leadership and guidance to EP ASCP and ASVP staff as directed by VP, EP
• Hire, evaluate and manage EP associates, contractors and/or vendor personnel
• Support expansion of Program activities to global or new locations
• Oversee submissions with the ASCP IRB and EC
• Provide monitoring expertise and manage assigned clinical site(s)/project(s)
• Ensure site staff follow protocols and regulatory standards (GCP/ISO)
• Maintain audit-ready regulatory files for assigned sites/projects
• Onsite daily presence in Franklin Lakes, NJ

Skills

Leadership

Project management

Regulatory compliance

Clinical trials

Communication

Team management

Education

Licensed Healthcare Practitioner (RN/PA/NP)

Bachelor’s degree in Science-related field

Clinical trial management certification

Job description

We are the people who give possibilities purpose

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.

Job Description

Responsibilities:

• Provides leadership and assistance to the EP ASCP and ASVP staff and allied associates on matters pertaining to the Programs’ services, policies, procedures, and staff, as directed by the VP, EP
• Hires, evaluates and manages EP associates, contractors and/or vendor personnel who engage in Program activities, as assigned.
• Works alongside the Director, EP to help support global or regional locations or Business Units who wish to expand Program activities in existing or new locations.
• Responsible for all submissions and communications with the ASCP IRB and EC
• Responsible for providing monitoring expertise to the project team and effectively manage assigned clnical site(s)/project(s)
• Oversee and ensure site staff execute protocols according to plan (protocol) and in compliance with regulatory requirements/standards (GCP/ISO), IRB/EC policies and procedures, and BD established standards
• Prioritize subject safety is maintained and informed consent procedures are carried out and documented properly
• Maintain complete and audit-ready regulatory files for assigned site(s)/project(s) that comply with company and industry parameters, e.g. ALCOA
• Required to be onsite daily in Franklin Lakes, NJ.

Education and Experience:

• Licensed Healthcare Practitioner (HCP), such as RN, PA, NP. Minimum Bachelor’s degree in a Science related field
• Certifications in clinical trial management from recognized training entities (is a plus)
• Minimum 5 years’ experience in human clinical trials (GCP experience preferred)
• Minimum 5 years’ experience in Program Management activities and in people management
• Minimum 3 years’ experience in Site Monitoring (preferred)

Knowledge and Skills:

• Excellent communication and presentation skills, proficiency in interacting productively with internal and external customers
• Ability to anticipate and resolve problems
• Ability to lead cross-functional efforts and teams
• Ability to work independently as well as collaboratively within a team setting
• Ability to write clearly and analytically; fluent in English

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.

Health and Well-being Benefits

• Medical coverage

• Health Savings Accounts

• Flexible Spending Accounts

• Dental coverage

• Vision coverage

• Hospital Care Insurance

• Critical Illness Insurance

• Accidental Injury Insurance

• Life and AD&D insurance

• Short-term disability coverage

• Long-term disability insurance

• Long-term care with life insurance

Other Well-being Resources

• Anxiety management program

• Wellness incentives

• Sleep improvement program

• Diabetes management program

• Virtual physical therapy

• Emotional/mental health support programs

• Weight management programs

• Gastrointestinal health program

• Substance use management program

• Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit

Retirement and Financial Well-being

• BD 401(k) Plan

• BD Deferred Compensation and Restoration Plan

• 529 College Savings Plan

• Financial counseling

• Baxter Credit Union (BCU)

• Daily Pay

• College financial aid and application guidance

Life Balance Programs

• Paid time off (PTO), including all required State leaves

• Educational assistance/tuition reimbursement

• MetLife Legal Plan

• Group auto and home insurance

• Pet insurance

• Commuter benefits

• Discounts on products and services

• Academic Achievement Scholarship

• Service Recognition Awards

• Employer matching donation

• Workplace accommodations

Other Life Balance Programs

• Adoptionassistance

• Backup day care and eldercare

• Support for neurodivergent adults, children, and caregivers

• Caregivingassistancefor elderly and special needs individuals

• Employee Assistance Program (EAP)

• Paid Parental Leave

• Support for fertility, birthing, postpartum, and age-related hormonal changes

Leave Programs

• Bereavement leaves

• Military leave

• Personal leave

• Family and Medical Leave (FML)

• Jury and Witness Duty Leave

Why Join Us?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.

Required Skills

Optional Skills

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Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You".

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role’s specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

$172,000.00 - $275,200.00 USD Annual