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.
US employees must be fully vaccinated against COVID-19 prior to your start date unless an accommodation is granted by The Company. The Company uses the definition of "fully vaccinated" assigned by the Centers for Disease Control & Prevention for purposes of considering satisfaction of this requirement which is a condition of employment.
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.
Responsible for developing and leading Global regulatory strategies for submissions and approvals of clinical trials and original marketing authorization applications for devices or digital health tools within the Merck Group (EMD Serono) digital health and device portfolios. You will implement our wide Digital Health and Drug/Device combinations products regulatory strategy, in conjunction with technical, development, commercial, IP and business development teams by supporting projects and work streams according to agreed deliverables, timelines and budget.
• Provide and lead regulatory strategy for assigned products within the company's digital health and medical-device portfolios in both Clinical trials or commercialization
• Identify and execute on opportunities to build a relationship of trust, scientific credibility, and partnership with relevant internal and external stakeholders (such as health authorities) leading to early engagement to accelerate development
• Work effectively in the broader matrixed organization to deliver an aligned and successful regulatory strategy
• Ensure compliant and timely operational execution of all required regulatory updates, submissions, and reporting responsibilities
Who You Are:
- Degree in a Life Science or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)
- Over 10 years of experience in regulatory affairs of medical devices or digital healthcare with at least 3+ in regulatory strategy and submissions of digital health tools, Software as Medical Device (SaMD) globally and Combination products
- Detailed understanding of global regulatory requirements for drug-device combination products.
- Proven track record of effective collaboration with the regulatory authorities (US FDA in particular), demonstrated ability to act as a credible, influential, respected spokesperson during interactions
- Proven record of working in a device or a digital health tool regulatory team that is to be used along with medicinal product or as a part of drug development during a trial. Hands on experience working on human-factor studies related to drug/device combination products and engagement with health authorities on running such studies.
- Ability to negotiate within a highly matrixed environment to deliver complex messages and facilitate appropriate team decisions, insightful and forward thinking, ability to recognize, anticipate and proactively manage regulatory need
- Actively engages colleagues, interacting broadly with other members of GRA
What we offer:
- Demonstrated track record of success contributing in a globally oriented environment
- Skilled in presenting management with recommendations that reflect full consideration of available options and a strong business judgement on balance of risk
- Communicate with clarity, impact, and passion tailored to the audience
- Excellent written and spoken communication skills in English
- Good interpersonal skills
- Attention to details
- Ability to lead and work in teams
- Strong organizational and planning skill
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!Our Benefits -
Apply and find more information athttps://jobs.vibrantm.com
If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.
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.
Job Requisition ID: 232293
Career Level: D - Professional (4-9 years)
Working time model: full-time