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Associate Director, Global Regulatory Affairs, Biomarkers & Diagnostics

Posted 25 May 2018

Billerica, Massachusetts - United States

Req Id 175493

Details

A career with EMD Serono is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.


Your Role:

As Associate Director you will be part of the global regulatory team within biomarkers and diagnostics. You will be supporting the product teams in development of regulatory strategy for companion diagnostics (CDx) and other clinical biomarkers supporting clinical drug development. You will be engaged in developing plans for companion diagnostics and their compliance with applicable global legislations and regulations with particular focus on US and EU in collaboration with internal and external stakeholders. Additional responsabilties include:

  • With a high level of self-sufficiency, preparing and coordinating the development of CDx regulatory milestones & documents independently and in collaboration with CDx external partners
  • Serving on global regulatory subteams as a subject matter expert
  • Conceptualizing and evaluating of regulatory strategies for CDx development
  • Reviewing and/or drafting content of regulatory submissions (e.g. Presubmissions, Investigational Device Exemptions, Premarket Approvals, and CE mark)
  • Leading strategy and executing regulatory agency interactions through document preparation, and coordination of rehearsal
  • Working with internal and external partners to deliver on program goals

Who You Are:

  • Graduate degree in a scientific discipline (or equivalent)
  • 5+ years of experience in IVD regulatory affairs or IVD development
  • Strong background in scientific principles of IVD technology and their development 
  • Experience in development of digital technologies would be a plus
  • Experience with prior health authority interactions
  • Ability to interact in matrix organization
  • Strong written and oral communication skills
  • Travel approximately 4-6 times a year

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at come2emd.com

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.

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