Manufacturing Team Member II

Job Description Summary

The System Governance, Operations Associate is an integral member of Global Clinical Affairs in assisting in preparing Trial Master Files (TMF) for completeness and regulatory audit. A successful System Governance, Operations Associate will regularly demonstrate exceptional analytical and problem-solving skills to mitigate risk and deliver high quality results.  They possess a strong understanding of trial master file documents, clinical management systems and processes to perform TMF quality checks and ensure audit readiness.

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.

Trial Master File -

• Must be an expert in TMF documentation.

• IRB/EC

• Provide support and training to trial team members on the proper use of CA TMF repository system and Good Documentation Practices.

• Actively review and manage the status of trial documentation to ensure accuracy and completeness of TMFs.

• Continually enforce good documentation and system workflow practices while performing quality check reviews on TMF essential documents.

• Perform periodic audits of TMFs to ensure trial documentation is filed appropriately, in compliance with project and policy requirements as a proactive approach for regulatory inspection readiness.

Additional Operations

• Collaborates with all areas of GCA to ensure operational processes are followed

• Demonstrate effective time management in completing tasks on time, managing work tasks, prioritization of work, etc. Proven ability to prioritize multiple tasks in a business environment and work independently, at times with minimal supervision.

• Proactively maintain open lines of communication, and act as a liaison among several internal groups and services.

• Manage multiple activities and functions daily.

Minimum Requirement:

• High School or GED Equivalent Required. Degree level qualification; or equivalent combination of education and experience

• DIA reference model guide required

• TMF documentation experience required. Expert level preferred.

• IRB/EC strongly preferred.

• VEEVA Vault Experience preferred

For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

To learn more about BD visit https://bd.com/careers

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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PDN

Primary Work Location

USA AZ - Tempe Headquarters

Additional Locations

USA NJ - Franklin Lakes

Work Shift