Temp - Vendor Compliance Manager

Location
Basking Ridge, New Jersey
Posted
Jun 26, 2022
Ref
REGEA0026R12045
Required Education
Bachelors Degree
Position Type
Contract

Accountable for driving and managing TMF Health across Functional Areas and their vendors to ensure TMFs are always inspection ready. Ensuring Global Development (GD) leadership are informed, understand the impact of metrics and the required action plans for remediation.  Accountable for working with the Functional Areas to develop appropriate actions to improve TMF Health and resolve TMF documentation issues.  Advocates and promotes active TMFs to support decision-making with all internal and external functional area stakeholders, escalating as necessary.   Central point of contract for functional area vendors.

JOB DUTIES:  

  • Accountable for driving and managing TMF Health (quality, completeness and timeliness) across Functional Areas to ensure TMFs are always inspection ready.
  • Ensure GD leadership are informed and understand the impact of metrics and the required action plans for remediation.   
  • Point of Contact for TMF Forum members  and their functional service providers
  • Develop and promote actions for the functional areas to improve TMF Health and resolve TMF documentation issues.
  • Advocates and promotes active TMFs to support decision-making
  • Advocate and promote TMFs to be always inspection ready with all internal and external functional area stakeholders. 
  • Collect and escalate Functional Service Provider TMF issues as necessary to internal counterparts and work with them to resolve.
  • Effectively communicate and drive document management compliance, quality issues and TMF Health metrics to functional areas and their management.
  • Address general questions or training needs from the functional areas.
  • Verify TMF metrics are accurate across all reporting tools.

JOB REQUIREMENTS:

  • A demonstrated, deep understanding of the TMF Reference model and processing of documentation into the eTMF system.
  • Demonstrated ability to prioritize and manage multiple projects simultaneously
  • Must have strong presentation skills and be confident in presenting findings
  • Demonstrated ability to work effectively with many different types of personalities at all levels of the organization
  • Excellent interpersonal, collaboration and stakeholder management skills
  • Excellent communication skills (written/verbal)
  • Highly self-motivated, flexible, able to follow through in an ambiguous, fast-changing environment, and proven ability to meet deadlines under pressure
  • Highly organized and detail oriented, while also demonstrating the ability to synthesize information and demonstrate strategic thinking
  • Highly proactive, flexible, curious and resilient
  • Proficient in Microsoft Applications; Word, Excel, Project, and PowerPoint
  • Ability to travel (<10%)

Bachelor’s degree or equivalent and 5 years of experience required.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.