1+ months

Project Manager/Project Leadership- Biosimilar

West Chester, PA 19380

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!

We offer a competitive benefits package including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee Stock Purchase Plan and Tuition Assistance. For more information on Teva, check us out at www.tevapharm.com or www.tevausa.com

The Project Leader has overall responsibility for leading the global development of their products; ultimately to maximize the products potential. They will lead the cross-functional project teams for high value, high cost drug development programs. In specialty The Poject Leader may work in partnership with a more Senior Project Leader to establish, maintain and deliver the priority product plan for both early and late stage. specialty Project Leader will also lead establish projects alone and based on experience and expertise early stage programs as well. The Project Leader may also act as a deputy of director and Sr director in Project Leadership.

 

  • Project Leader will be responsible for delivering both  Gx & specialty a product development strategy approved by governance and securing investment for the development program. They are accountable for leading delivery of the approved programs to time, cost and quality and in accordance with Teva strategy and priorities. 
  • Lead the overall Biosimilar development strategy of the product. This includes integrating cross-functional strategic plans such as commercial leadership of the target product profile, clinical leadership of the clinical development plan and CMC leadership of the pharmaceutical development plan. 
  • Lead the cross-functional team to secure approval and funding for the overall product development plan.
  • Lead the cross-functional project team through the strategic planning and delivery of the development program, proactively identifying and managing issues and risks and ensuring decisions are made at the appropriate levels and with the appropriate cross-functional input.
  • Lead cross-functional delivery to the agreed development budget and timeline collaborating with the cross-functional team members to track and manage issues in budget and timelines and bringing significant variations to PAC/PRC for approval based on agreed trashold
  • Collaborate with function leads to ensure their teams are fully resourced and skilled appropriately to deliver, working expeditiously to highlight any resource gaps that impact the program delivery or quality.
  • Collaborate with all relevant functions to ensure the right level of expertise and quality is built into the programs including clinical, commercial, regulatory, CMC, operations, pre-clinical, bio PK, IP, TPO etc.  Participate in sub-team leadership. 
  • Work with Sr Project Leader ensure the team has a high quality risk management plan and that significant risks to the programs have planned mitigations and are flagged in terms of likelihood and impact, to the relevant leadership.
  • Develop and manage end to end product development plans in MS Project / Planisware to accurately reflect the tactical plan/timeline and interrelated functional. For specialty early & late stage program work on project timeline with Sr Project Leader
  • Ensure all relevant documentation is accurate, current, and approved by respective leadership.
  • Provide strong leadership to the cross-functional project team .ensure that expert input from all key functions is incorporated into the plans.
  • Represent the Director and Senior Director Project Leadership on committees, special projects or initiatives and/or may assume responsibility on a periodic or interim basis. 

Overall Experience:

  • 5 plus years of experience in the pharmaceutical industry and at least 3plus years leading development projects (Generic/specialty) through to registration and launch
  • Solid understanding of drug development, industry guidelines, and regulatory and submissions processes globally
  • Experience leading a cross-functional project team through all stages of development
  • Established track record of effective and influential oral presentations including presenting investment opportunities to senior executive teams

Preferred:Experience:

  • Delivering MAA/NDA/BLA/JNDAs as well as sNDAs and proven track record of delivery lifecycle management programs
  • Experience delivering ANDA approval

Specialized or Technical Knowledge Licenses, Certifications needed:

  • Project Management Professional (PMP) preferred
  • Excellent computer software skills, specifically Planisware / Microsoft Project, SharePoint, PowerPoint, Word, Excel and Outlook

Functional Knowledge:

  • In-depth knowledge of the drug development process in Generic/specialty

Education:

Bachelors level degree in scientific fieldPreferred: Advanced scientific degree (M.D., D.O., Ph.D.)

Travel Requirements:
Willingness and ability to routinely travel domestically and abroad.

Categories

Posted: 2020-11-23 Expires: 2021-03-24

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.

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Project Manager/Project Leadership- Biosimilar

Teva Pharmaceuticals
West Chester, PA 19380

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