- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation, ... electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with lead CDx RA representative(s) and represent Global CDx Regulatory position and provide input and updates within internal cross-functional teams (eg, ... an assay into clinical testing (before testing) and once data is ready for CDx submission (after testing)Serve as...device company HA meetings as appropriateIn collaboration with therapeutic Regulatory leads and CDx lead develop key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulatory requirements, and other relevant guidelines.- Accountable for Data Management deliverables meeting/exceeding study team expectations regarding quality ... centered around rare diseases and immune disorders. Summar y : The Manager, Data Management is accountable for end-to-end delivery of clinical data management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global data management strategy across regions and across studies/programs. Lead DM resource model internalization for both strategy and implementation in terms ... data review and cleaning, database lock), to ensure data quality/integrity and regulatory complianceEnsures that Data Management Plans are consistent and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs the Product Security Lead Designer, you will play a pivotal role in shaping the security landscape of our organization. Your primary ... responsibilities will include:Designing Security Controls: Lead the design and implementation of innovative and robust security controls across various domains… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …from clinical trials or post-marketing for completeness, accuracy, expectedness and relatedness. Lead internal and external (especially regulatory , but also ... Disease/Specialty Medicine portfolio. SummaryThe Director, Clinical Safety, will be a product safety lead or part of a product safety team, and be responsible for… more
- Merck & Co. (Rahway, NJ)
- …solid knowledge of statistical methodology, experimental design, computing software and data management; a general understanding of worldwide regulatory ... to designing and analyzing clinical trials in support of worldwide regulatory submissions.This position involves interaction with Medical, Data Coordination,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Specialty Medicine portfolios, in alignment with the business strategy Lead the DSG inspection management activities by ensuring continued submission, compliance ... and inspection preparedness for the respective MA inspections in alignment with regulatory and company strategy. Act as management representative for all key health… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …be responsible for driving customer impact by overseeing 5D efforts including Data , Diagnostics, Drug, Device, and Digital strategy and execution for relevant TAs, ... Market Access and Public Affairs (MAPA), Field Sales, Commercial Excellence, Regulatory Affairs, Integrated Customer Engagement, Global and other relevant NNI… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Review, Data Surveillance, targeted source document verification and targeted source data review. Lead the team to develop and implement metrics including ... position requires strong knowledge about RBQM, and related processes, policies, regulatory requirements and ICH guidance. This position requires excellent project… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the Novo Nordisk US Operations (USO) AI Center of Excellence. The individual will lead and manage a team of data scientists, including AI/ML experts and ... evolve the Data Science team to meet internal and market needs. Lead a high-performing, collaborative team environment.Core member of the AI Center of Excellence,… more
- Merck & Co. (Rahway, NJ)
- …and ability to comprehend statistical analysis methods and clinical data management conceptsAbility to anticipate stakeholder and regulatory ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... on Project Teams.Responsibilities: Study Strategy: Provides the strategic direction to Biostatistics Data Management & Data Ops for EDC, edit checks, … more
- Merck & Co. (Rahway, NJ)
- …cell bank and working cell bank) manufacturing operationsStrong understanding of regulatory requirementsAbility to lead without authority, build trust, and ... Reporting directly to the Biologics Drug Substance Commercialization Leader, you will lead the Cell Banking working groups and drive innovation in biologics DS… more
- Merck & Co. (Rahway, NJ)
- …DescriptionOur Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new ... Distinguished Scientist (Executive Director) and Product Development Team (PDT) lead , Oncology Global Clinical Development, has primary responsibility for the… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... Director will perform job duties independently with minimal supervision and/or lead QP2 efforts on drug/vaccine development programs, and author or co-author… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …reviews CPI/KPI/GPI where applicableParticipates in the development of calibration data sheets, metrology job plans and associated master plansParticipates in ... and collaborating with key stakeholders and functionsActively participates in all regulatory and internal audits of the facilityPartner and manage relationships with… more
- Merck & Co. (Rahway, NJ)
- … Data Analysis, Hematology, Intellectual Curiosity, Medical Research, Oncology, Regulatory Affairs Compliance, Regulatory Reporting, Regulatory ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be responsible… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... offers an opportunity for the Pharmacometrics leader to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be… more
- Merck & Co. (Rahway, NJ)
- …supply programs. They independently perform routine audits of batch documentation, data , information, procedures, equipment and systems, and/or facilities to ensure ... and our Company procedures. They will also collaborate with the Quality Program Lead to issue reports summarizing results, works with area to ensure resolution of… more
