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Associate Manager TMF Governance

Date: Jan 16, 2021

Location: West Chester, Pennsylvania, US, 19380

Company: Teva Pharmaceuticals

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description

Responsible for ensuring that Teva studies have comprehensive and quality TMFs ready for audits and inspections according to Teva processes.  Support, consult, and coordinate with each study team for confirming the structure and plan for the TMF including but not limited to the set-up of the study structure in the eTMF, study team assignments within the eTMF, confirm QC content is completed according to plan, and oversee closure of the study eTMFs.  Act as the Teva eTMF system SME and administrator. 

 Support, consult and provide TMF guidance to the TMF accountable function(s) during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF.  Lead, as assigned, cross-functional TMF oversight through the life cycle (planning, set-up, oversight, closeout, archival) of the study TMF.

Ensure Teva’s cross-functional eTMF business process and operating model is followed for each study and determine differences from standard TMF structure is documented. 

Manage the Teva eTMF system as an administrator ensuring study TMFs are built according to the specific study architecture for inputs including: country and site objects; vendor and account objects; study team assignments; baseline milestones and baseline expected document lists.  

Support the department lead of TMF Governance in the management of departmental priorities and lead, direct, or conduct other projects/tasks as requested.

Qualifications

Bachelor degree required

2+ years pharmaceutical industry  

1-2 years in trial master file/records management, inspection readiness, clinical operations, and/or related quality/compliance position.  

Understanding of ICH/GCP requirements required. 

Working knowledge of GxP requirements and of clinical development and medical affairs is preferred

Function

Project Management

Sub Function

RandD

Reports To

Research & Development Project Leader

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.


Nearest Major Market: Philadelphia