Manager, Medical Affairs Lifecycle Management

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Affairs Marketed Products

Job Category:

Scientific/Technology

All Job Posting Locations:

Cleveland Ohio United States Columbus Ohio United States Dayton Ohio United States Palm Beach Gardens Florida United States of America Raynham Massachusetts United States of America Warsaw Indiana United States of America West Chester Pennsylvania United States of America

Job Description:

We are searching for a Manager Medical Affairs Lifecycle Management to join our DePuy Synthes Team. Remote work options may be considered on a case-by-case basis and if approved by the Company

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Are you passionate about improving and expanding the possibilities of Orthopedics Ready to join a team thats reimagining how we heal Our Orthopedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports extremities and elective foot and ankle; spine; and robotics and digital surgery.

Your unique talents will help patients on their journey to wellness. Learn more at & Johnson announced plans to separate our Orthopaedics business to establish a standalone Orthopaedics company operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months subject to legal requirements including consultation with works councils and other employee representative bodies as may be required regulatory approvals and other customary conditions and approvals.

Should you accept this position it is anticipated that following conclusion of the transaction you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes programs policies and benefit that case details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Purpose: The Manager of Medical Affairs LCM provides medical writing support at a clinical trial level and delivers training with regards to study procedures and protocol criteria and ensures adherence to protocol requirements and quality management practices as applicable. Interacts with the external clients internal team members key opinion leaders and physician consultants/contracted reviewers around the development of required clinical trial documents.

You will:

• Provide Lifecycle Management for marketed products including labelling updates medical support and accountability for technical files and documents and medical support to Quality groups.
• Support literature review analysis and conclusions for Clinical Evaluation Reports (CERs) and related documents (i.e.: SOA; CEP; Literature Review SSCP PMCF) and provide final review of CERs and related documents.
• Research prepare and document responses to Medical Information Requests from Healthcare providers.
• Review and approve medical content in Copy Approval process; consult with Clinical Medical Directors when needed.
• Collaborate closely with the Clinical Medical Directors in support of business responsibilities.
• 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 others ensure 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.
• Perform other duties assigned as needed including internal process insight management and business development and evidence generation support.
• Guide junior colleagues through consultation and mentoring in techniques and processes and provides functional (matrix) supervision.

Qualifications:

• Relevant health-related degree (MD DO DPM PhD RN PA-C etc.) required.
• Minimum of 5 years of experience in clinical patient care (preferably Orthopaedics) and 5 years of relevant experience in pharmaceutical or medical device lifecycle management is required.
• Knowledge of Orthopaedics conditions and devices used in the diagnosis and management of Orthopaedics conditions including knowledge of medical alternatives treatment standards and technology is required.
• Knowledge of clinical trial design evidence generation adverse event reporting surgical practices/principles is required.
• Demonstrated knowledge and experience in quality compliance regulatory compliance and healthcare compliance is required.
• Operating room experience is preferred.
• People management 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 and similar applications.

Johnson & Johnson is an 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 disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource

Required Skills:

Preferred Skills:

Clinical Operations Clinical Trials Medical Affairs Product Lifecycle Management (PLM) Project Management Life Cycle (PMLC)

The anticipated base pay range for this position is :

$137000-$230000. California Bay Area: $168000-$230000

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees and/or eligible dependents are 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. Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Companys long-term incentive program. Subject to the terms of their respective policies and date of hire Employees are eligible for the following time off benefits: Vacation 120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year Holiday pay including Floating Holidays 13 days per calendar year Work Personal and Family Time - up to 40 hours per calendar year Parental Leave 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave 10 days Volunteer Leave 4 days Military Spouse Time-Off 80 hours Additional information can be found through the link below. Experience:

Manager