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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

Job Function:

R&D Operations

Job Sub** **Function:

Clinical/Medical Operations

Job Category:

Professional

All Job Posting Locations:

West Chester, Pennsylvania, United States of America

Job Description:

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/

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

Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics 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 https://www.jnj.com/medtech

This role will be based at West Chester, PA.

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

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

Leeds UK Requisition Number - R-010906

Zuchwil, Switzerland- Requisition Number - R-010890

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

\#Li-Hybrid

\#LI-RP1

The Sr. Manager, Scientific Operations provides leadership, motivation, and strategic direction for the general technical writing activities for the generation of Clinical Evaluation Reports/Plans (CER) and Summary of Safety and Clinical Performance Reports (SSCP) for their assigned therapeutic area within J&J Global MedTech. They also support broader initiatives and cross-platform activities to support the continuous process improvement activities of the Scientific Operations Team.

+ Provides strategic oversight and guidance to resources on compliant document execution and generation

+ Responsible for the effective optimization and harmonization of CER and SSCP processes within this space while aligning with the J&J Enterprise guidelines and regulatory requirements

+ Ensures the CER and SSCP processes are linked to appropriate Quality Systems and Regulatory Processes (e.g., Risk Management, PMS, etc.) to ensure information is accessible where needed and will develop, implement, and manage an effective communication model for CERs/SSCPs

+ Provides strategic oversight and guidance to all CER/SSCP resources on compliant document execution and generation

+ Manages relationships and contracting with external vendors for generation of documents supporting these processes

+ Develops strategic plans to ensure operating company CER timelines are met, and practices are being consistently deployed across the global organization

+ In conjunction with the Director, designs, develops and leads workshops to define processes globally and keeps abreast of regulatory requirements and industry trends / practices, ensuring that a proactive ongoing review of processes and procedures is in place to maintain a strong regulatory profile while continually improving process efficiencies

+ Develops and monitors metrics for CERs within his/her therapeutic space, providing visibility of issues and enable corrective and preventive action to be taken as needed

+ Accountable for assisting in the development and management of the Scientific Operations budget pertaining to the businesses within his/her scope of responsibility

+ Supports interactions with respective Notified Bodies and regulatory agencies regarding CERs and SSCPs

+ Supports audits and inspections pertaining to CER and SSCP processes and reports.

+ Actively partners with cross-functional business partners such as Clinical Affairs, Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs relating to the CER/SSCP process

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

+ Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

+ 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

EXPERIENCE AND EDUCATION

+ BA, BS, or BSN is required; advanced degree is preferred

+ Minimum of 7 years of related job experience with 3 years of people leadership experience is required

+ Experience within the medical device industry and knowledge of Clinical Evaluation Report regulatory requirements, evidence generation, and Clinical Evaluation Report (CER) document creation is required

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

+ Demonstrated knowledge and experience in clinical research, quality regulatory compliance, adverse event reporting is preferred

+ Previous experience developing and implementing system processes is preferred

+ Regulatory/Notified Body front room audit experience is preferred

+ Previous budgetary experience is preferred

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 ([email protected]) or contact AskGS to be directed to your accommodation resource.