Sr. TMF Systems Specialist

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

Position Summary:

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 eTMF Veeva system SME and administrator

Essential Duties & Responsibilities:

1.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.
2.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.
3.Oversee eTMFs are ready for audit/inspection purposes by ensuring there is a study specific TMF plan.
4.Manage the 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.
5.Serve as main subject matter expert for the eTMF system and identifies areas for continuous improvement for the management of the system.
6.Provide input to departmental operating procedures, work instructions, training materials, systems, and tools.
7.Work with the Audit and Inspection Readiness team, as needed, with a focus on preparing and supporting study teams for GCP and pre-approval related inspections on the study TMF compliance and completeness.
8.Support the Associate Director of TMF Governance and Audit & Inspection Readiness in the management of departmental priorities and lead, direct, or conduct other projects/tasks as requested.

Qualifications

Education Required:

Bachelor degree in science or equivalent experience, with preference in a healthcare field, or equivalent is required.

Experience Required:
3-5+ years pharmaceutical industry experience with at least 2 years in trial master file/records management, inspection readiness, clinical operations, and/or related quality/compliance position.

Experience Preferred:

Study start-up and close-out.

Specialized or Technical Knowledge Licenses,

Functional Knowledge:

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

General Management

Reports To

In process of validation

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