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Senior Manager Global RA Biomarker

Company: Merck KGaA
Location: Billerica
Posted on: June 7, 2021

Job Description:

A career with EMD Serono is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 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.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your role:

An exciting new opportunity to join the global regulatory affairs team for biomarkers and diagnostics as a manager/senior manager. As part of the regulatory team, this role supports the product teams in development of regulatory strategy for companion diagnostics (CDx) and other clinical biomarkers for use in clinical development. You would 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.

Who you are:

Minimum requirements:

  • Graduate degree in scientific discipline (or equivalent)
  • Several years (min. 2) of experience in CDx regulatory affairs or CDx development
  • Strong background in scientific principles of IVD technology and their development
  • Strong written and oral communication skills
  • Experience with prior health authority interactions
  • Ability to interact in matrix organization

Preferred Qualifications:

  • Experience in development of digital technologies would be a plus
  • Strong English skills required, German skills preferred

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

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 their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

Keywords: Merck KGaA, Billerica , Senior Manager Global RA Biomarker, Other , Billerica, Massachusetts

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