- Sanofi Group (Morristown, NJ)
- …an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and ... possible. Ready to get started? **Main Responsibilities:** + Develop CMC regulatory strategies and assess associated risks for development projects and/or registered… more
- Sanofi Group (Morristown, NJ)
- …+ PhD in Mathematical Statistics, Biostatistics or other quantitative science discipline with advanced expertise in biostatistics. + A minimum of 12 ... senior leadership. + Expertise in emerging technologies in data science and AI/ML. + Knowledge of regulatory ...data science and AI/ML. + Knowledge of regulatory requirements and guidelines related to statistical analyses in… more
- Sanofi Group (Morristown, NJ)
- …leading and overseeing all statistical work for clinical development and regulatory submissions, leading a team focused on clinical development strategies, ... Head partners closely with clinical teams, Clinical Sciences & Operations (CSO), regulatory experts, and key stakeholders to accelerate the delivery of medicines to… more
- Sanofi Group (Morristown, NJ)
- …who has an extensive experience with the preparation of clinical documents and regulatory dossiers and has demonstrated leadership skills as submission lead. As an ... company with one purpose: to chase the miracles of science to improve people's lives. We're also a company...for study start, conduct and completion, as well as regulatory submissions according to company standards and procedures with… more
- Merck (Rahway, NJ)
- …+ PhD in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with eight (8) years relevant experience ... development and technology teams, supply chain, operations, quality, analytical, regulatory , and project leaders. The successful candidate will demonstrate ownership… more
- Merck (Rahway, NJ)
- …+ PhD in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with eight (8) years relevant experience ... substance and drug product container closure systems including mold qualification and regulatory compliance. To act as master data stewards and support enterprise… more
- Merck (Rahway, NJ)
- …mitigates risks across all factors that may impact technical, operational & regulatory success or timelines. Analyzes and develops innovative solutions to unforeseen ... circumstances. + Responsible to ensure the best science and most robust processes are used, working closely with DCRC. As the Product TPL takes ownership for the… more
- Merck (Rahway, NJ)
- …for MQSA. **Education Minimum Requirement and Experience:** + Bachelor of Science (BS) Degree in Microbiology, Biology, Medical Technology, Pharmacy, Microbiology, ... Chemical Engineering, or related science discipline with ten (10) years' experience in sterile...(8) years' experience in sterile pharmaceutical industry. **OR** + PhD in Microbiology, Biology, Medical Technology, Pharmacy, Microbiology, Chemical… more
- Sanofi Group (Morristown, NJ)
- …an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and ... manuscripts; clinical pharmacology or ECET components of investigator brochures, regulatory documents. + Interact effectively with managers from various disciplines;… more
- Merck (Rahway, NJ)
- …**OR** + PhD in packaging, mechanical, chemical, biochemical engineering, pharmaceutical science or chemistry or related fields with eight (8) years of relevant ... and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make… more