- Daiichi Sankyo, Inc. (Bernards, NJ)
- …from HAs. Contribute to providing timely feedback for Dx Partners to address regulatory questions from Global Health Authorizes (HAs) during review of device ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Eisai, Inc (Nutley, NJ)
- …and objectives of the Business Group for these programs as related to regulatory submissions and milestones including interactions with Health Authorities. This ... to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company...to hear from you. Job Summary The Executive Director, Regulatory Affairs will provide leadership and direction for the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …identifying areas of potential non-compliance or operational risks.Responsibilities:Maintain regulatory procedural documentation, in line with company-wide policy ... other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory… more
- Genmab (NJ)
- …portfolio of products. The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be within ... work instructions, templates, and associated documentsThis position may also support regulatory policy and/or intelligence deliverables:Monitor the regulatory… more
- Novo Nordisk Inc. (WA)
- …and gathering insights from other departments (Corporate Tax, MA, Comm'l BUs, Medical, Regulatory , Legal, etc) Assigned policy areas may include, but are not ... by creating an environment where innovation and chronic disease management drive optimal health outcomes. Are you ready to realize your potential? This role can sit… 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 healthcare 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 health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to experiment with us? The Position The Senior Manager Health Care Professional Marketing will be responsible for supporting the development and ... and finance teams to ensure alignment with business objectives and regulatory requirements. Essential Functions Brand/Therapy Area Management o Support the… more
- Genmab (NJ)
- …methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role ... analyses requiring advanced statistical methodologies/techniquesRepresent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various ... talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and other...three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days,… more
- Merck & Co. (North Wales, PA)
- …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 .This position supports statistical programming activities for multiple and/or late stage drug/vaccine clinical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …project portfolio and prioritize and drive projects from inception through regulatory approval to global implementation.Requirements BS required, Ph.D. preferred in ... network and drive change management process from inception through regulatory approval to global site implementation.Candidate must have extensive experience… more
- Genmab (NJ)
- …Manager to help us tell the story of our science through compelling clinical and regulatory documents. You'll be at the heart of a team that plays a critical role ... development of high-quality clinical documents to support operational, medical, and regulatory activities across the Genmab portfolio. You will help craft… more
- Eisai, Inc (Raleigh, NC)
- …healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking ... is responsible for executing core quality assurance functions, supporting regulatory inspections, and collaborating with internal and external stakeholders to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …understanding of pricing implications and downstream impact of the evolving public policy , government, regulatory landscape and other relevant trends Identifies ... of pricing implications and downstream impact of the evolving public policy , government, regulatory landscape and other relevant trends Continuously… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and collaborating with key stakeholders and functionsActively participates in all regulatory and internal audits of the facilityPartner and manage relationships with ... of work and compliance with all company policies and regulatory guidelinesHelps improve metric performance to drive team results...three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Market Access and Public Affairs (MAPA), Field Sales, Commercial Excellence, Regulatory Affairs, Integrated Customer Engagement, Global and other relevant NNI ... Oversee development and implementation of data, diagnostics, drug, device, and precision health focused strategy and execution for relevant TAs that aligns with Rare… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Customer Call Center, Enterprise Insights, Supply Chain, Procurement, Public Affairs, Public Policy , Regulatory , Legal, IT, Trade, Patient Safety and Compliance. ... as well as fostering relationships with both patients and health care professionals. Works closely with Enterprise Insights, Finance,...also offers time off pursuant to its sick time policy , flex-able vacation policy , and parental leave… more
- Eisai, Inc (Nutley, NJ)
- …healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking ... opinion leaders, advisors as well as US and EU regulatory bodies in order to conduct Phase I, Phase...equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …efficient utilization of the warehouse space. This individual will assist in regulatory inspections, perform safety and quality audits, and answer relevant questions ... optimization and efficient utilization of the warehouse space.Assist in regulatory inspections, perform safety and quality audits, and answer...three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days,… more