- 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
- 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)
- …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. (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 ... strategy closely aligned with the business strategy within one or more Global Project Team(s) (GPT) within Oncology Development Franchises or Business Units. Provide… 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
- 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
- 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)
- …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 ... centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, and analytic support… more
- Insmed Incorporated (Bridgewater, NJ)
- …Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Director , Toxicology is a key member of the nonclinical ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...certification preferred.Minimum of 15 years of experience as a regulatory toxicologist (study director /monitor and/or project lead)… more
- Insmed Incorporated (Bridgewater, NJ)
- …discipline. DABT/DACVP certification preferred.Minimum of 10 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...certification preferred.Minimum of 10 years of experience as a regulatory toxicologist (study director /monitor and/or project lead)… 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
- 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
- Merck & Co. (Rahway, NJ)
- …LATAM and APAC. Leads site EHS leaders and influences site, region and global business partners to drive prioritization of regulatory compliance, continuous ... collaborative relationships with stakeholders.Demonstrated ability to successfully negotiate with regulatory agencies and senior operations leaders; escalates… more
- Merck & Co. (Rahway, NJ)
- …commercial input on such activities as: target product profile development, global regulatory filing strategy, labeling, launch readiness reviews, organized ... Job DescriptionWe are currently recruiting for a Director , Global Marketing for Women's Cancer...chain: basic science and biology, clinical development and innovation, regulatory processes, global launch dynamics, access and… 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research ... momentum, and an inspiring mission to achieve new milestones in global healthcare. Our company's Pharmaceutical Sciences & Clinical Supplies organization translates… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, ... and natural killer (NK) cell-based immunotherapy. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of… 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)
- …compliance councils. Key performance indicators range from quality and regulatory compliance, operational excellence, pipeline program support, financial, talent ... functional groups in development, quality, safety, facilities management, analytical, finance and regulatory .-FLEx was designed to be a facility that evolves to meet… more
