- Merck & Co. (Rahway, NJ)
- …to peptides, pediatric formulations, and devices. The Executive Director , as a senior member of the Global Regulatory Affairs and Clinical Safety: ... GRACS CMC Leadership Team. Their role is pivotal in fostering alignment and global execution across Regulatory Affairs, R&D, Manufacturing, and our Commercial… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The Director , Global eQMS Management QA GMP, reports to the Senior Director , Strategic GMP QA Operations. This individual is a member of the ... and regulatory requirements. Drive collaboration, alignment and awareness across Global Quality and GMP related functions (Supply Chain, Regulatory Affairs,… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to maximize your potential with us? The Position As the Senior Director Supply Chain Operations and North America Demand Planning, you will ... the opportunity to build a life-changing career in a global business environment. We encourage our employees to make...Supply Chain Operations. This position regularly interacts with the senior leadership in Pricing & Contracting, Regulatory ,… 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
- Merck & Co. (Rahway, NJ)
- …questions for optimizing model-based development-Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, ... chemical entities and biologics, and inform dose selection and go/no-go decisions. Senior Directors lead QP2 efforts to strengthen our pharmacometric capabilities on… 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)
- …drive revenue and productivity, thereby advancing our Company 's contribution to global medical innovation. Enterprise IT (EIT) is an essential component of the ... EIT SAP Platform Team is responsible for our Company's SAP Global Template asset, delivering enterprise-level capabilities through harmonized business processes and… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Key Opinion Leaders (KOLs), Healthcare Professionals (HCPs), and other stakeholders. The Medical Director will also assist the Senior Medical Director in ... Area in certain instances, at the discretion of Executive Director of Medical Affairs. Assists the Senior ...Core Medical Team, at the discretion of the Executive Director Represent NNI Medical Affairs on Global … 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
- 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
- Merck & Co. (Rahway, NJ)
- …or related areas of study.Required:Minimum of 10 years of experience in a senior role such as Marketing, Global meetings, events, experiential marketing or ... Job DescriptionDescription of PositionThe Global Commercial and Digital Experience (CDX) team is...for a dynamic and visionary Events and Experiential Marketing Director to develop and lead the vision for our… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.SummaryThe Senior Director of Clinical Operations will manage clinical operations ... and ensure ongoing collaboration and communication with internal stakeholders. Detailing The Senior Director will ensure a robust communication plan including… 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
- 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
- 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
- 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
