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Danaher Corporation Director Medical Affairs (m/f/d) in Amsterdam, Netherlands

We are currently looking for a Director Medical Affairs (m/f/d) to join our European Medical Affairs team. The ideal location can be anywhere in Europe working remotely with travel globally.

POSITION SUMMARY:

This post provides critical clinical insight, combined with deep experience in laboratory testing, to advise Cepheid on technologies and strategies in EMEA. As Director Medical Affairs (m/f/d) you will play a critical role in interfacing with Cepheid Global and EMEA marketing teams and directly with customers to help define the next generation of Cepheid products, and in design and managing clinical studies of current and incipient Cepheid products. You will work closely and interact regularly with the Cepheid Medical Affairs teams globally. You will present Cepheid technology in various formats (oral presentations, written Med/Sci Affairs documents, publications, webinars, videos, etc.) to all stakeholders, including internal groups such as Sales, Marketing, Tech Support, etc. and external groups such as regional, national, and international scientific meetings, KOLs, customers, and prospective customers.

ESSENTIAL JOB RESPONSIBILITIES:

  • Support Senior Directors in Medical Affairs by responding directly to customers regarding Patient Safety Board referrals, Technical Consults, and Med/Sci requests for off-label support

  • Membership of Medical Advisory Board, Complaint Review Board and Field Action Board

  • Support the set-up and monitoring of RUO and post launch studies of on and off label indications and support collaborators in presenting and publishing results

  • Prepare written materials such as Guidelines, Bulletins, letters, and training materials

  • Support Senior Directors in Medical Affairs in engaging with KOLs, arranging Scientific Advisory Board meetings and other opportunities to assess Voice of the Customer

  • Give presentations to both internal and external stakeholders at meetings or via webinar

  • Review documents for Quality or Regulatory submissions as needed to satisfy Regulatory body requirements

  • Support the development of a database of suitable publications and presentations for responses to off-label requests

  • Provide support to core and launch excellence teams for new products

  • Engage with international KOLs at local, regional, and international meetings to stay current with latest diagnostic and management trends

MINIMUM REQUIREMENTS:

Education or Experience (in years):

Bachelor’s degree with 12+ years of related work experience or Master’s degree in field with 8+ years of related work experience or a Doctoral degree in field with 5+ years of related work experience.

  • M.D. with Microbiology or Infectious Disease training strongly preferred.

  • Deep expertise in a range of relevant diagnostic areas

  • Fluent written and spoken English and at least one of French and/or German

  • Understanding of regulatory and compliance requirements in relation to all aspects of in vitro diagnostic devices

  • Ability to travel up to 40-50% time

  • Ability to develop and maintain professional relationships with a wide range of stakeholders including clinicians and laboratorians

  • Creativity, high level of motivation, ethical approach to all aspects of the role

Knowledge and skills:

  • Good understanding of regulatory requirements for in vitro devices

  • Proficient in computer skills including some knowledge of reference management tools

  • Excellent written and verbal communication skills

Other:

  • Teamwork, autonomy, availability, organizational and situational awareness.

  • Demonstrate excellent time management and organization, project management skills

  • Understanding of regulatory and compliance requirements in relation to all aspects of in vitro diagnostic devices

  • Operates with transparency and humility

  • Acts as a role model for high ethical standards and code of conduct

  • Self-motivated, independent and creative problem solving

  • Solid interpersonal and communication skills

  • Work independently and team orientated

  • Proficient in computer skills (Excel, Word, PowerPoint)

What we offer

  • An attractive remuneration package and flexible working hours

  • A friendly and nice working atmosphere on our Krefeld site with great colleagues

  • An exciting, holistic task within a global team and an opportunity to work with leading edge technology and high-end products

  • As part of the Danaher Group, continuous training, support and focus on your personal development is one of our key goals

  • We at Danaher and Cepheid recognize that creating a culture rooted in Diversity and Inclusion is an ongoing journey and became “Best Employer for Diversity”.

Are you interested to discover new opportunities in an innovative, collaborative environment? Do you feel that this could be your future position? Then do not hesitate to apply. We are looking forward to your application!

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

Operating Company: Cepheid

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