- Sun Pharmaceutical Industries, Inc. (Blawenburg, NJ)
- The Senior Director ( Global Regulatory Portfolio Leader), Global Regulatory Affairs (GRA), Specialty Business (Brands and Innovative Medicines), ... therapeutic areas and (potentially) develop a team of US and/or global regulatory leaders (as assigned). Where possible, and leveraging contemporary mechanisms,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(GRL Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, ... with other therapeutic area leaders and joint Alliance partners.Responsibilities:Lead a multidisciplinary Global Regulatory Team (GRT) to develop global … more
- Sun Pharmaceutical Industries, Inc. (Blawenburg, NJ)
- Senior Director , Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug ... individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway, interacting with … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC...team and serves as ad hoc member to the Global Project Team for late stage projects. This position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... define and oversee the translational strategy/plan for oncology therapeutic program/s in global R&D. The successful candidate will set goals and enumerate key… more
- Merck & Co. (Rahway, NJ)
- …monitoring, analysis, regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre-clinical ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist)...closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the benefit of patients and global human health. Responsibilities :Supervises a group of statisticians in Late Development Statistics.Provides biostatistical and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …accordance with 21CFR part 58 (Good Laboratory Practice (GLP), and other global regulatory authority requirements, and industry best practices.Ensure /support ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) ... closely collaborates with the key stakeholders and leaders across the Global Daiichi Sankyo R&D organization to achieve desired business results (short-term,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …interactions at a project level, and interacts with regional and global project team members, senior management, and outside vendors.Responsibilities:Responsible ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing Clinical ... hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and Pharmacometrics/… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical/oncology project development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Rahway, NJ)
- … Specialist, Environmental Sustainability, Global Safety & Environment The Senior Specialist will report to the Director , Environmental Sustainability Center ... and responds to evolving environmental sustainability trends, market conditions, regulatory requirements, etc. -Evaluates and integrates the information to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans,… more
- Merck & Co. (Rahway, NJ)
- …placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible ForEvaluating pre-clinical and ... company in the United States and Canada, is a global health care leader with a diversified portfolio of...and dedicated colleagues while developing and expanding your career.The Senior Director (Sr. Principal Scientist) has primary… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research ... forward momentum, and an inspiring mission to achieve new milestones in global healthcare. The Biologics and Biopharmaceutics team is responsible for the research… more
- Merck & Co. (Rahway, NJ)
- …placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible ForEvaluating pre-clinical and ... Job DescriptionOur company is a global health care leader with a diversified portfolio...and dedicated colleagues while developing and expanding your career.The Senior Director ( Senior Principal Scientist)… more
