Johnson & Johnson's Medical Device Business Services is recruiting for a Technical Writing Manager, located anywhere in United States.

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.

The 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.

Primary Responsibilities:

• Provides strategic oversight and guidance to all CER 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 and, if applicable, Sr. Manager, 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.

• 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

Minimum Requirements:

• Minimum of a Bachelor's Degree is required; Advanced Degree strongly preferred.

• Minimum of 5+ years of relevant job 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.

• Able to understand and interpret statistical results of clinical studies and understands good data management practices.

• Strong oral communication, presentation, project management and prioritization skills

• Excellent interpersonal relationships.

• Position can be performed remotely. Work onsite is preferred.

• Up to 10% Domestic and International Travel may be required.

This job posting is anticipated to close on 8/14/2024. 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.

The anticipated base pay range for this position is 113000 to 195500. California Bay Area - The anticipated base pay range for this position is 139000 to 224825.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. 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 and/or eligible dependents may be 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.

Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

Vacation - up to 120 hours per calendar year

Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year

Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market."

#LI-RP1