A career with EMD Serono is an ongoing journey of discovery: our 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. 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.
Key accountabilities of the Head of US Regulatory and Scientific Policy are to help drive the global, strategic development of EMD Serono R&D policy agenda and execution by providing key regional input. Support development of the portfolio and maximize lifecycle management by identifying US scientific and regulatory policy issues/trends that have the potential to impact our products and ensure information is utilized with key internal stakeholders to optimize product strategies, standardize global approach and ultimately enhance asset probability of success. Support regional regulatory affairs and product development with focused regulatory intelligence support.
- Actively engage externally to shape the US regulatory policy environment in line with EMD Serono R&D goals and objectives. Partner with key functions and relevant subject matter experts to set policy agenda, engage in regional regulatory advocacy relating to regulatory healthcare policies and actively engage in US Trade Association initiatives, authority policy meetings and consultation on draft guidance.
- Analyze and interpret new or changed regulatory guidance, legislation, or policies from health authorities in collaboration with relevant stakeholders to determine impact on company’s business and working practices
- Participate or coordinate participation in external industry/health authority working groups to influence changes in regulatory guidance, legislation, or policies
- Provide regulatory policy interpretation regarding therapeutic areas and products
- Guide the US Global Regulatory and Scientific Policy team in all of the above
- Manage direct reports; manage 3rd party vendors for outsourced work; manage internal cross-functional teams without direct reporting relationship; manage relationships with key senior leadership responsible for R&D priorities. Cross-functionally provide technical guidance on policy related matters.
- Support the internal development of Global Scientific/Regulatory Policy Agenda in close partnership/cooperation with other
- lobal Regulatory and R&D functions and Commercial. Drive regional execution/advocacy strategy and facilitate delivery via relevant functions/individuals.
- Lead the development of regional priorities and agenda and ensure alignment with global R&D positions
- Build mutually beneficial relationships with external key regional stakeholders (e.g. health authority leadership, thought leaders, trade associations etc.) in order to advance R&D agenda.
- Negotiate with relevant external leadership to advance regional regulatory reform.
Who You Are:
- Bachelors Degree
- 13+ years of experience in drug development/regulatory in the biotech/pharmaceutical industry, with a minimum of 2 years supervisory/management experience
- Externally recognized as regional regulatory policy thought leader; lead coalition development and advocacy strategies with key stakeholders; lead trade association policy advocacy.
- In depth knowledge of drug development process/FDA/ICH regulations and processes and demonstrated capabilities in policy agenda/advocacy strategy setting.
- In-depth experience with Trade Associations, advising senior leadership as well as strong oral and written communication skills. In depth knowledge and experience with Trade Associations
- Experience advising senior leadership
- Fluent in English
- Ability to work in a fast paced, matrixed, multinational work environment
- Ability to work effectively as part of a global organization with internal executives, government officials and association executives
- Position requires both domestic and international travel up to 20% of time
- Master Level Education (M.S., MBA, or PharmD) preferred
- Strong oral and written communication skills
- Ability to lead across functions and drive to common agenda
- Teamwork orientation and interpersonal astuteness
- Personal adaptability and initiative
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 https://jobs.vibrantm.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 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.