- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the leadership team . Lead an enterprise cross-functional QA team to deliver state-of-the-art data -driven solutions.Design a fit-for-purpose organization ... technologies, and drives process improvements. Collaborating with the Global QMS eCompliance team , the director oversees QA plans, promotes data governance, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Data Review, Data Surveillance, targeted source document verification and targeted source data review. Lead the team to develop and implement metrics ... centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring)...activities.- Technical: Provides technical guidance in Quality by Design. Lead the team to define Critical to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: The Senior Director sits within Global Oncology Clinical Development, an organization dedicated ... UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable for the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for GDX global and regional projects requiring Validation services and Technical Lead assignments.ResponsibilitiesOversee and manage a team of Validation Leads ... around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …designated programs.Ensure proactive representation of Quality professionals at strategic non-project team and at MA strategic discussions. Lead the Quality ... other research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required Travel: Ability to ... an assay into clinical testing (before testing) and once data is ready for CDx submission (after testing)Serve as...gathering country/region specific CDx RA requirements from local RA team members (eg from Japan, China, Australia, Canada, Korea… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …productive work environment. This pivotal position will report directly to the Senior Director of Operations.Key Responsibilities Champion and lead the employee ... Biotech is seeking a Employee Engagement Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewJoin our dynamic team at Legend… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and ... on Project Teams.Responsibilities: Study Strategy: Provides the strategic direction to Biostatistics Data Management & Data Ops for EDC, edit checks, … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …matters, including performance reviews and departmental talent development.Line management and senior leadership accountabilities in CoELead a team of safety ... of Excellence (CoE), Global Medical Safety will oversee a team of safety physicians and scientists across various regions,...resources for key programs. The role will also provide senior safety leadership and guidance on complex issues across… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(USO) AI Center of Excellence. The individual will lead and manage a team of data scientists, including AI/ML experts and statisticians, and is tasked with ... and vision.Build and evolve the Data Science team to meet internal and market needs. Lead ...senior leaders to drive strategic analytics transformations.Partner with Data Strategy, AI Engineering, and IT teams to ensure… more
- Merck & Co. (Rahway, NJ)
- …direction of the Sr Principal Scientist Patient-Centered Endpoints & Strategy (PaCES) lead , the Senior Scientist has responsibility for coordinating global ... Senior Scientist will work closely with the PaCES lead to collaborate with individuals from Clinical Research, Regulatory...Team (CTT) meetings on behalf of the PaCES lead to facilitate alignment of the selection of an… more
- Tris Pharma (Monmouth Junction, NJ)
- …our proprietary science and technology.Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris' passion and ... a successful business and take pride in the company's success. Equally importance to each team member is how we interact with one another on a daily basis. We… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …mix. Provides mentoring to junior members of Market Access Insights & Analytics team in adopting advanced data engineering methods. Continues to assess product ... strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our… more
- Merck & Co. (Rahway, NJ)
- …to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within Research Laboratories is committed to rapidly delivering ... and engage with the scientific community to influence the field.As a Senior Principal Scientist, you will drive various strategic initiatives and translate… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director, Biologics to lead all Chemistry, Manufacturing, and Controls ... biologic products, ensuring alignment with company goals and global regulatory standards. Team Development Build and lead a high-performing CMC team… more
- Merck & Co. (Rahway, NJ)
- …company to save and improve lives. Within IT, the IT Strategy Realization (ITSR) team 's purpose is to lead value-driven outcomes and accelerate how we transform ... (FTE) and contingent workers, ensuring effective collaboration and performance across team members. Principal Responsibilities Change Management Lead Assess the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategies that enhance the overall customer experience across all touchpoints. This role will lead a skilled team of behaviour science experts to design and ... on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring...based on real-world results. We are building an intentional team culture that is made up of diverse skillsets,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and reporting Represent the Ethics & Compliance function in technology and data analytics discussions with senior leadership Physical Requirements 10-20% ... Nordisk, we're committed to building the best Ethics, Compliance & Privacy (ECP) team in the pharmaceutical industry. Operating at the highest ethical & privacy… more
- Formation Bio (New York, NY)
- …are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team ... and more efficiently.About the PositionWe are looking for a Senior Software Engineer, Applied AI to join our dynamic... Software Engineer, Applied AI to join our dynamic team at Formation Bio. As we continue to revolutionize… more
- Merck & Co. (Rahway, NJ)
- …Capable of tailoring communications to diverse audiences, including governance bodies, senior leadership, team members, and individuals with diverse ... target commercial product.-Leads the cross-functional DCT, critically assessing all team deliverables & fostering a learning and collaborative environment.… more
