Manager, Scientific Operations (Technical & Medical Writing) - Medical Device Business Services, Inc

Description

Johnson & Johnson MedTech, a member of Johnson & Johnson family of companies, is recruiting for a Manager, Scientific Operations Technical & Medical Writing. The preferred location for this position is Raritan, NJ or Irvine, CA however remote options within the United States 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 Scientific Operations (SciOps) Technical & Medical Writing Manager, will provide strategic oversight and governance ensuring compliance in Sci Ops functions charged with delivery of key regulatory and medical documents. You will lead a diverse Sci Ops team based globally and will ensure the identification and retention of high potential individuals through active engagement, motivation, employee development, and promotion.

Specifically, the Manager will lead the execution of Clinical Evaluations and Summaries of Safety and Clinical Performance (SSCP) for multiple MedTech franchises. Additionally, the manager would support the review of Literature Reviews and Periodic Safety Updates in compliance with the EU MDR. The manager will provide leadership and maintain relationships through extensive interdependent partnering, benchmarking, and forming strategic alliances with cross functional business partners to drive key business goals and objectives. Furthermore, the manager will lead interactions with the Notified Body and the drafting and alignment on response strategy and execution.

Primary Responsibilities

Lead a team of medically proficient scientists and technical writers across the various J&J Med Tech franchises to compile and analyze product related safety and performance data, collaborate on strategy, draft reports and coordinate approvals. Be responsible for the effective optimization and harmonization of CER and SSCP processes within MedTech while aligning with available guidelines. Ensure the CER and SSCP processes are linked to appropriate Quality Systems and Regulatory Processes to ensure information is accessible where needed and will develop, implement and be responsible for an effective communication model. Generate materials, lead workshops, and deliver training to ensure adequate implementation of guidelines and contribute to the professional development of employees. Develop and supervise performance and compliance metrics providing visibility of issues and enabling risk mitigation, corrective and preventive action to be taken as needed. Partner with R&D, Medical Affairs, Clinical, and Regulatory in the establishment of appropriate routes of conformity for clinical evaluations for new products introductions and product design changes. Track and trend Notified Body questions and observations across applicable MedTech franchises to improve processes and enhance compliance. Translate insights into viable process and solutions that create value.

The base pay range for this position is $115,000 to $175,000 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

Required Qualifications

Minimum of a Bachelor’s degree is required; Advanced Degree strongly preferred. Life Sciences field of study is desired. Minimum of 8+ years of related experience in a regulated environment required. 5+ years of medical device experience in the field of technical or medical writing, post market surveillance, clinical trials, or product risk management strongly preferred. 2+ years people leadership (Project or FTE) experience required. Experience in a highly compliant environment. Proven knowledge and experience in quality, regulatory, post market surveillance, post market quality, adverse event reporting, clinical trial design, or clinical trial. Experience building relationships and managing globally across a multi-business environment. Project Management/Six Sigma training or certifications highly desired.

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 4/29/2024. 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.