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Manager LCM - 2406196440W

Description

Johnson & Johnson is currently seeking a Manager LCM to join our Medical Device Business Services, Inc. located in West Chester, PA.

There is an internal pre-identified candidate for consideration. However, all applications will still be reviewed.

Remote work options may be considered on a case-by-case basis and if approved by the Company.

About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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.

Job Summary

Manages 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 Operating Entity Medical Leaders. Provides Strategic Medical support for cross-platform Orthopaedics.

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.

Qualifications

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

• Relevant degree is preferred (PhD, RN, 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

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 .

Primary Location NA-US-Pennsylvania-West Chester

Organization Medical Device Business Services, Inc (6029)

Job Function Medical Affairs & Marketed Products

Req ID: 2406196440W