- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders.Summary This role is responsible for leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through direct and indirect line ... corporate initiatives, ensuring that DS is prepared to meet new or proposed global regulatory requirements and that DS has a voice in defining new requirements.… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the ... 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder minimal guidance of the Senior Director or Director , Business Development Execution, the primary function includes coordinating various ... GRACS functional areas, to ensure implementation and maintenance of regulatory activities associated with assigned Company Business Development (BD) Agreements.-… more
- Merck & Co. (Rahway, NJ)
- …(QCI) colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.) ... the global inspection tracking system that tracks all GCP Regulatory Health Authority inspections, findings, responses and Corrective Action and Preventive… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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 ... indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- Merck & Co. (Rahway, NJ)
- …placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible For:Evaluating 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
- Insmed Incorporated (Bridgewater, NJ)
- …DABT/DACVP certification preferred. Minimum of 15 years of experience as a regulatory toxicologist (study director /monitor and/or project lead) in the ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...New York™, and Best Workplaces for Millennials™ lists.OverviewOverview The Director , Toxicology, is a key member of the nonclinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis 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. (Basking Ridge, NJ)
- … interactions at a project level, and interacts with regional and global project team members, senior management, and outside vendors.ResponsibilitiesResponsible ... 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. (Basking Ridge, 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- Insmed Incorporated (Bridgewater, NJ)
- …lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of Pharmacovigilance QA serves as a strategic partner ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and… more
- Insmed Incorporated (Bridgewater, NJ)
- …the reinforcement and ongoing growth of our culture. This position will report to the Senior Director , HCP and Payer Lead. This position does not have any direct ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , HCP Marketing will be a key member of… more
- Merck & Co. (Rahway, NJ)
- …cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be ... Job DescriptionOur company is a global health care leader with a diversified portfolio...and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director in ensuring that appropriate Corporate… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDevice Development Principal Scientist - Device Development Lead ( Director Equivalent) Our company's Device Development (DD) Team designs, develops, ... products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional… more
- Merck & Co. (Rahway, NJ)
- …This position will focus on oncology products.Under the direction of a HEDS Senior Director , the Principal Scientist provides strategic development and use of ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
