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Senior Manager, Global Medical Affairs

Date: Mar 15, 2019

Location: Amsterdam, NL, 1019 BR

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

A new exciting opportunity has arisen for a Senior Manager, Global Medical Affairs to join us in Amsterdam. In this role you will be a global strategic partner across Teva’s therapeutic areas supporting Global Launch Management, Medical Processes, GMA Operational Excellence. You will oversee the processes associated with and the governance of the management of GMA lead clinical studies, compassionate use programs and global ISS coordination and governance.

As a Senior Manager, Global Medical Affairs you will interact directly with internal and external stakeholders in order to ensure the timely execution of medical activities on time and on budget. You will be also responsible for maintaining policies and SOPs essential for compliance.

Key responsibilities:

 

Global Medical Launch Management:

  • Supporting Global and Regional Medical Affairs teams with the execution of Medical launch plans including but not limited to Ajovy, Austedo and fasinumab.
  • Timely execution of launch plan by aligning monthly with medical functions to manage and update the medical launch plan.
  • Risk identification and mitigation planning; working with medical functions to identify risks, develop mitigation plans and maintain risk register.
  • Working closely with medical functions to update KPIs to measure team’s success.

 

Medical Affairs Excellence:

  • Development of various SOPs and Work Instructions related to Excellence and Compliance in the execution of Global Medical Affairs led activities, in alignment with the Specialty R&D Systems and Standards team, Specialty Clinical Development and Global Medical Affairs.
  • Budget support for Therapeutic Areas:
    • Summarize monthly spend reports from Finance.
    • Schedule and facilitate monthly budget meetings with stakeholders from GMA and GCO.
    • Collate Global HQ AOP budgets and medical plan presentations for submission to Sr. Leadership.

 

Evidence Generation:

  • Governance and global study oversight responsibility for CSS, ISS and compassionate use and expanded access programs (CUP/EAPs).
    • Governance, oversight and coordination of Medical Affairs sponsored studies, and support for MARC meetings as needed.
    • Governance, oversight and coordination of the Investigator Sponsored Studies, support for IRC meetings including partner with compliance and legal as needed regarding appropriate ISS program oversight.
    • Tracking of EAPs and CUPs across TAs.
  • Developing and aligning stakeholders regarding data generation planning for:
    • Inclusion in the Medical Plan (and Launch plan, where applicable).
    • Guidance for medical teams late phase study design and execution.
    • Dovetailing with clinical development plans for fully lifecycle evidence generation of assets.
  • Assisting with study start up activities in partnership with GCO and Procurement; e.g. SDC/protocol development, vendor selection, convene study team, MARC presentation.
  • Development and refinement of relevant policies, SOP and Work Instructions.
  • Working with internal stakeholders across regions, TAs and departments to facility successful processes for data generation including late phase study development and launch as well as Investigator Sponsored Studies programs.

Qualifications

  • Bachelor's degree, ideally in a job-related field.
  • Significant Medical Affairs experience, ideally with an international/global exposure.
  • Previous pharmaceutical/biotechnology/academic/governmental agency experience (or related).
  • Proven track record of working collaboratively across different cross-functional teams such as commercial, R&D, health outcomes, regulatory, pharmacovigilance and compliance/legal.
  • Ability to build strong working relationships with key stakeholders (internal and external business partners).
  • Ability to work in a changing and flexible environment in an adaptive way with a “can-do” positive attitude.
  • Proven track record of working in a matrix set up, facilitating desired outcomes by integrating business partners from various regions with different personal background.
  • Excellent English in speaking and writing.
  • Willingness to travel internationally – 10-15%


Experience preferred:

  • Experience in relevant Teva therapeutic areas would be a plus.
  • Previous Clinical Trials experience would be beneficial.

Function

Medical Affairs

Sub Function

Medical Affairs

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.