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Mgr, Clinical Supply Project Manager

Date: Nov 24, 2021

Location: Netanya, IL, 11111

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

 

Position Summary:
The primary responsibility of the Clinical supply PM is to design, plan and manage the supply fo all clinical trials from startup to closer in partnership with other functions.

 

Essential Duties & Responsibilities:

  • Participates in the review of the protocol, collects and communicates suggestions for a protocol change to responsible author on behalf of CSC
  • Manages and maintains collaboration with clinical study team in order to define study timelines, kit design and supply planning
  • Collaborates with Teva relevant parties to identify vendors (CMOs/CROs), perform selection and contracting, define the scope of work and R&R between Clinical CRO, CSC Third party vendors and Teva
  • Manages the study budget and ensures accurate and timely payment of invoices to the CRO and vendors
  • Plans drug product demand, sourcing of comparators as required and ensures timely delivery within the specification, quality and standards
  • Plans the secondary packaging and facilitates the process for final drug release
  • Initiates label generation and oversees approvals, label regulatory adaptation and translations activities in collaboration with CRO and 3rd party vendors
  • Design IRT (Interactive response technology) system, set-up, testing, and oversees maintenance
  • Manages and maintains the interaction with CROs, CMOs and other vendors in setting the business requirements of the CSC operational systems
  • Proactive and continuous risk management of the E2E clinical supply chain (back-up countries, inventories, shelf life, etc.)
  • Continuously manage and supervise CSC vendor's quality and delivery within timelines, scope and budget
  • Responsible for Accountability, Returns and Destruction of supplies
  • Ensues compliance of the clinical supply activities with the ICH GCP, GMP, GDP guidelines and Teva SOPs
  • Participates in review, development, and revision of department SOPs

Qualifications

Education Required:

  • College degree or higher, preferentially in pharmacy/engineering/sciences

Experience Required:

  • At least 4 years experience as a project manager, preferably in pharmaceutical industry.
  • Computer literate
  • Fluent in English

Job-Specific Competencies:

  • Strong communication and organizational skills
  • Strong project management and influencing skills
  • Experience to manage supply chain
  • Ability to flag issues in a timely manner and perform issue escalation
  • Flexible and able to work in a changing environment, multi-tasking and deadlines
  • Team player who can also operate independently
  • Solution-oriented and problem solving attitude
  • Vendor/CRO and budget management skills

Function

Project Management

Sub Function

RandD

Reports To

Sr. mgr, Clinical Supply Chain PM, Clinical Operations

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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.