Experienced Business Coordinator, Medical Analytics and Safety Surveillance (MASS)

Johnson & Johnson is hiring a Business Coordinator Medical Analytics and Safety Surveillance (MASS) to be located in Titusville, NJ.

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/.

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 Business Coordinator will support and facilitate the efficient and effective operations of Medical Analytics and Safety Surveillance (MASS). The coordinator will be responsible for organizing and coordinating various tasks and projects, as well as administrative tasks, ensuring smooth communication and collaboration among team members. Some may involve exposure to confidential and time-sensitive materials requiring discretion and judgement. Performs independent analysis of project and administrative responsibilities selecting the best course of action while prioritizing demands. This role will be responsible for providing administrative support to the VP, MASS, archiving system, Inspection/CAPA support, coordination of project updates and MASS metrics. This position reports to the VP of MASS.

Key Responsibilities:

Project Coordination:

• Monitor and track project progress, identifying and addressing any potential issues.
• Assist in the preparation of presentations, reports, and other relevant documents.
• Act as a central point of contact for team members, facilitating communication and information sharing.
• Create and publish metrics for MASS
• Contract Management project coordination; Create and manage purchase orders/invoicing and other agreements.
• Ad hoc tasks as assigned by the supervisor.
• Coordinate tracking of contracts across the organization; processing statements of work, as needed.

Records Coordination and facilitation

• Responsible for the compliant archiving and retrieval of all documents and artifacts in line with current J&J records retention requirements and legal holds
• Advising on retention
• Procedure documentation revision
• Document updates of versions and interface with controlled document group
• Documentation support in Docspace/TruVault
• Preservation of records for audits and inspections
• Serve as the primary point of contact for all records inquiries

CAPA/Inspection Support

• CAPA management support, timelines, submissions
• Enter CAPA documents in COMET.
• Inspection support such as keeping track of timelines, schedules, etc.
• Ensure compliance related to inspection/CAPA requests
• Act as primary point of contact between MASS and Quality organization.

Administrative Support

• Direct support for the VP, MASS including calendar management, travel coordination, and processing expense reports.
• Support for MASS, including complex travel and expenses and coordination of team meetings (logistics, technology, catering, etc.).
• Coordinate recruiting activities, candidate communications, interview schedules, and onboarding of new team members.
• Management of team office supplies/equipment