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 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.
This role can be based in Washington, DC or Billerica, MA
The purpose of this US Director of Global Regulatory and Scientific Policy is to lead the tracking, monitoring, evaluating, analyzing and communicating of regulatory intelligence of impact to EMD Serono to inform product strategies. Actively engage externally (as directed) to shape the regulatory policy environment in line with EMD Serono Research and Development goals and objectives. Coordinate overall R&D engagement with Trade Associations, Health Authorities and other key stakeholders to drive US Regulatory reform. Coordinate EMD Serono Scientific positions/responses into the global pharmaceutical commenting system.
- Understand U.S. Regulatory environment/trends and define/articulate available regulatory options
- Conduct analysis of regulations/guidance/precedent and how applicable to project.
- Lead regulatory science projects, conduct competitive regulatory intelligence and benchmarks to inform product strategies.
- Coordinate and deliver cross-functional communication/education to convey complex regulatory policy issues, impact to the business.
- Help maintain strategic Regulatory Science Advisory Network with the aim to ensure best use of regulatory opportunities in the global environment, supporting a positive regulatory contribution to development programs.
- Support the development of EMD Serono regional regulatory and scientific policy priorities (inclusive of R&D strategy) and advocacy agenda by coordinating with GRASP team and executive management as directed.
- Respond to regional regulatory/legislative policy issues that impact R&D and lifecycle management of EMD Serono products.
- US lead for any formal commenting by EMD Serono to Health Authorities, Trade Associations etc.
- Lead and coordinate cross-functional R&D engagement in trade associations, consortia etc to drive company priorities. Support executive management in trade association leadership roles with Science and Regulatory positioning.
- Engage thought leaders on project level to ensure optimal scientific input.
- Identify and liaise with internal subject matter experts to ensure robust responses/advocacy to external stakeholders.
Who You Are:
- Bachelor Level education in healthcare related field
- Fluent in English
- 5 years of experience in drug development/regulatory in the biotech/pharmaceutical industry
- Knowledge of drug development process/FDA/ICH regulations and processes
- Understanding/experience in policy development and implementation
- Experience with Trade Associations
- Ability to work effectively with government officials and thought leaders
- Position requires both domestic and international travel up to 15% of time
- Experience with multi-stakeholder advocacy initiatives
- Demonstrated leadership (internal and external)
- Understanding of relvant regional legislative processes and intersection with regulatory requirements.
- Demonstrated ability to work cross-functionally and obtain results from individuals who have no reporting relationship.
- Ability to work in intense, fast paced, matrixed, multinational work environment
- Strong oral and written communication skills
- 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.