Manager, Lifecycle Management - Johnson and Johnson

Johnson and Johnson is currently seeking a Manager, Lifecycle Management located in Raynham, MA or Palm Garden Beach, FL.

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ .

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

This Manager will Handle the operational function in medical affairs to achieve organizational objectives. Provides life cycle management of the marketed product. This role will provide expertise in support of the Medical Strategy in concert with business unit Medical Leaders. Provides strategic medical support for cross-platform Orthopedics.

DUTIES & RESPONSIBILITIES

• Provide consultation in analysis, review, and conclusions for Clinical Evaluation Reports (CER) and related documents (i.e.: SOA; CEP; Literature Review, SSCP, PMCF).

• Provide Lifecycle Management for marketed products including labelling updates, medical support and accountability for technical files and documents and medical support to Quality groups.

• Collaborate closely with the Medical Directors in support of business responsibilities.

• Research, prepare and document responses to Medical Information Requests from Healthcare providers.

• Review and approve medical content in Copy Approval process; consults with Medical Director when needed.

• Provide medical oversight of publication strategy for selected marketed products in close collaboration with the Medical Affairs team.

• Prepare and/or manage preparation of presentations and manuscripts around clinical data as well as medical and scientific information, this includes hands on management of publications and maintenance of timelines.

• Contribute to value dossiers for marketed products.

• Assess work volumes, effectively prioritize business needs to meet the demand, and escalate workload constraints according to leadership strategy. Act as a team member supporting and collaborating with the other LCM managers.

• Responsible for communicating business related issues or opportunities to next management level.

• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

• Performs other duties assigned as needed. Requirements

• A minimum of 5 years of clinical, engineering or life science experience is required.

• Relevant degree is preferred (PhD, RN, PA-C, BSc, etc.).

• Some direct patient contact is preferred.

• Clinical experience with medical devices and knowledge of clinical trial design, evidence generation, adverse event reporting, surgical practices/principles is preferred.

• Demonstrated knowledge and experience in quality compliance, regulatory compliance, and healthcare compliance is preferred.

• Operating room experience is preferred.

• Verbal and written communication skills, problem solving, critical reading skills, knowledge of medical and anatomical terminology.

• Proficiency with standard office suites such as Outlook, Word, Excel.

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
  - Work, Personal and Family Time - up to 40 hours per calendar year

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 .

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

Eligible for benefits to include medical, dental, vision and time off as well as any others as provided for in the applicable Collective Bargaining Agreement.

For additional general information on company benefits, please go to: - https://www.careers.jnj.com/employee-benefits