Manager, Scientific Operations

Description:

The J&J MedTech Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.

Johnson & Johnson MedTech, a member of Johnson & Johnson family of companies, is recruiting for a Manager, Scientific Operations & Clinical Evaluations. This position can be located remotely with preferred locations in Raritan, NJ or Irvine, CA.

The Manager, Scientific Operations & Clinical Evaluations, will provide strategic oversight and governance ensuring compliance in Sci Ops functions charged with delivery of key regulatory and medical documents. You will lead a diverse Sci Ops team based globally and will ensure the identification and retention of high potential individuals through active engagement, motivation, employee development, and promotion.

Specifically, the Manager will lead the execution of Clinical Evaluations, State of the Art Reports, Literature Reports, Safety Surveillance Assessments, and Summaries of Safety and Clinical Performance (SSCP) for multiple MedTech portfolios with a focus on Electrophysiology, Neurovascular Care, and/or Aesthetic Reconstruction. The manager will provide leadership and maintain relationships through extensive interdependent partnering, benchmarking, and forming strategic alliances with cross functional business partners to drive key business goals and objectives. Furthermore, the manager will lead interactions with the Notified Body and the drafting and alignment on response strategy and execution.

Responsibilities:

• Lead a team of medically proficient scientists and technical writers across the various J&J Med Tech franchises to compile and analyze product related safety and performance data, collaborate on strategy, draft reports and coordinate approvals.
• Be responsible for the effective optimization and harmonization of Scientific Operations processes within MedTech while aligning with available guidelines.
• Ensure the CER and SSCP processes are linked to appropriate Quality Systems and Regulatory Processes to ensure information is accessible where needed and will develop, implement and be responsible for an effective communication model.
• Generate materials, lead workshops, and deliver training to ensure adequate implementation of guidelines and contribute to the professional development of employees.
• Develop and supervise performance and compliance metrics providing visibility of issues and enabling risk mitigation, corrective and preventive action to be taken as needed.
• Partner with R&D, Medical Affairs, Clinical, and Regulatory in the establishment of appropriate routes of conformity for clinical evaluations for new products introductions and product design changes.
• Track and trend Notified Body questions and observations across applicable MedTech franchises to improve processes and enhance compliance. Translate insights into viable process and solutions that create value.
• Manage budget and business cycles.
• Oversees administrative tasks including tracking, follow-up, filing, and reviewing documentation.
• Coaches and trains junior colleagues in techniques, processes, and responsibilities.
• Integrates Johnson & Johnson’s Credo and Leadership Imperatives into team goals and decision making.
  
  

Qualifications:

Required:

• Minimum of a Bachelor’s degree (University Degree) in Life Sciences, Engineering or related subject area
• Minimum of 8 years of related experience in a regulated environment (medical devices, pharmaceuticals, in vitro diagnostics, or other)
• Minimum of 5 years of medical device experience in the field of technical or medical writing, post market safety surveillance, clinical evaluations, clinical trials, or product risk management
• Minimum of 2 years people/interpersonal leadership experience
• Experience building relationships and managing globally across a multi-business environment
  
  

Preferred:

• An advanced degree, MBA, MS, or MD
• Project Management/Six Sigma training or certifications
  
  

This job posting is anticipated to close on February 14, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

The anticipated base pay range for this position is 115000 to 197800. California Bay Area - The anticipated base pay range for this position is 141000 to 227700.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Employees are eligible for the following time off benefits:
• Vacation – up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
• Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
  
  

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market."