AddressDescription
Medical Device Business Services, part of the Johnson & Johnson family of companies, is currently hiring for a Senior Manager, Scientific Operations to support our DePuy Synthes Joint Reconstruction business. The preferred location for this role is Warsaw, IN however remote options will be considered on a case by case basis.
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/.
The Sr. Manager, Scientific Operations provides leadership, motivation, and strategic direction for the general technical writing activities for the generation of Clinical Evaluation Reports (CER) and Summary of Safety and Clinical Performance Reports (SSCP) for their assigned therapeutic area within J&J Global R&D Medical Device sector. They also support broader initiatives and cross-platform activities to support the continuous process improvement activities of the Scientific Operations Team.
PRIMARY RESPONSIBILITIES:
· Provides strategic oversight and guidance to all CER 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 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 ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
· Performs other duties assigned as needed.
The base pay range for this position is $140,000 to $220,000 based on experience . The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus. 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 may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.
https://www.careers.jnj.com/employee-benefits
Qualifications
EXPERIENCE AND EDUCATION REQUIREMENTS:
· Minimum of a Bachelor’s Degree is required ; Advanced Degree is strongly preferred .
· Minimum of 7+ years of relevant related experience required .
· At Least 3+ years of people leadership experience 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 .
· 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 .
· Position can be performed remotely. Work onsite is preferred .
· Up to 10% Domestic and International Travel may be required .
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 .
This job posting is anticipated to close on 3/5/2024. 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.
