27 days old

Associate Manager TMF Governance

Teva Pharmaceuticals

West Chester, PA 19380

Apply Now

This job is brought to you by: CareerCast.com

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 Tevas 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.

Tevas 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.

Teva Pharmaceuticals

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

Job SeekersCreate a Resume

Get discovered by employers. Create your
job seeker profile and resume today!

Latest Jobs

About Our Partners

Employers have found us to be a cost effective resource to reach experienced, reliable temporary, part-time and seasonal workers and professionals and managers seeking project assignments.

RetailCareersNow.com. Post great jobs. Find great candidates. Now. Advanced features allow you to manage your job listings, candidate files and company profile data -- and track all associated activity concerning your job search securely. Take advantage of our expertise to connect with the thousands of highly qualified retail professionals who look to RetailCareersNow.com to make their next big move.

Looking for applicants with disabilities, including veterans? Look no further! RecruitDisability.org is your number one LINKAGE to this diverse talent pool. A program of The Sierra Group Foundation, we meet your training, accommodation & compliance needs for ADA and OFCCP.

Influential industry leaders and key decision-makers across many fields track Deadline many times a day and its postings regularly receive more reader comments than all of the entertainment industry news sites combined.

Our MISSION is to help reduce the already high unemployment rate among college grads with disabilities by uniting you with proactive employers. We will assist competitive career oriented college grads with disabilities in their search for employment in the entry level positions..

Recognized and respected throughout the world of show business, Variety is the premier source of entertainment news. Since 1905, the most influential leaders in the industry have turned to Variety for timely, credible and straightforward news and analysis — information vital to their professions.