Booz Allen Hamilton has been at the forefront of strategy and technology for more than 100 years Today, the firm provides management and technology consulting and engineering services to leading Fortune 500 corporations, governments, and not-for-profits across the globe. Booz Allen partners with public and private sector clients to solve their most difficult challenges through a combination of consulting, analytics, mission operations, technology, systems delivery, cybersecurity, engineering and innovation expertise.Regulatory Scientist
Work with cross-functional teams to develop and execute complex regulatory initiatives and business development strategies across multiple health-related markets. Manage and deliver health programmatic and analytics projects. Integrate regulatory expertise throughout the medical product life cycle with aspects of effective management and strategy development. Support regulatory science project teams in the analysis of client business needs, manage stakeholder relations, and play a significant role in staff and business development. This position is located in Rockville, MD.
-Experience with qualitative and quantitative safety and efficacy data sets
-Knowledge of regulatory health
-Knowledge of FDA regulatory requirements
-BA or BS degree
-5+ years of experience with project management
-5+ years of experience with business development in the government, biotechnology, pharmaceutical, or life science sectors
-Experience with product surveillance and safety pharmacovigilance
-Experience with consulting
-Knowledge of CDISC data standards
-BS degree in a life sciences field
-Regulatory Affairs Certification (RAC)
Integrating a full range of consulting capabilities, Booz Allen is the one firm that helps clients solve their toughest problems. by their side to help them achieve their missions. Booz Allen is committed to delivering results that endure.
We are proud of our diverse environment, EOE, M/F/Disability/Vet.