- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of data to ensure quality of results.- Service Provider Oversight and Management : Oversight of Data Request processing by Service Providers Training and ... of Daiichi Sankyo Pharmacovigilance Safety Systems, and fulfillment of data change requests.Responsibilities- Change Requests for PV Systems :Collaborate cross… more
- Genmab (Plainsboro, NJ)
- …essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be responsible for leading the development ... and maintenance of global labeling documents (eg, Core Data Sheet, USPI, EU SmPC and related patient information)...Regulatory Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …stakeholders and enhance and protect NNI's corporate reputation through digital community management and engagement. The Associate Director , Digital Content ... valued as we work together to change lives for the better. The Position The Associate Director , Digital Content Strategy & Production reports to the Dir, Content… more
- Genmab (Plainsboro, NJ)
- …Genmab products. Perform ongoing surveillance (including signal detection/evaluation) of safety data from Genmab clinical trials. Be the primary safety contact for ... Informed Consent, and Development Safety Update Reports. Establish and manage external Data monitoring Committees (DMCs) for early phase trials. Contribute to the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...internal stakeholders. In the execution of specific projects, the Associate Director , will be accountable for managing… more
- Genmab (Plainsboro, NJ)
- …be our best, and authentic is essential to fulfilling our purpose.The RoleThe Associate Director , US Marketing, Hematology will develop and implement brand ... first asset in hematology, EPKINLY. This critical role will report directly to the Director of EPKINLY HCP Marketing and be expected to work closely within the US… more
- Genmab (Plainsboro, NJ)
- …be our best, and authentic is essential to fulfilling our purpose.The Role & DepartmentThe Associate Director , Vendor Management , will play a pivotal role in ... for the vendors, across multiple trials, ensuring consistent communication and management .Manage MSAs for certain suppliers: own and manage the Master Service… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining ... internal stakeholders through the integration of primary market research and secondary data analytics. Incumbent must have the knowledge and technical skills to do… more
- Genmab (Plainsboro, NJ)
- …alignment, reporting, process optimization, data analysis and ongoing operations. The Associate Director of Field Operations works closely with internal and ... the leadership team specific to the business KPI's. The Associate Director of Field Operations will report... data inquiries, ensuring accurate reporting and CRM data management .Implements enabling technologies, such as field… more
- Genmab (Plainsboro, NJ)
- …implemented, and utilized at a pace never seen before. Join Genmab as an Associate Director , Solution Architecture and Engineering, R&D Digital Products as part ... systems and microservices.Experience with APIs (Applications and Programming Interfaces), integrations, Data Lake and federation, data management , full… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management , Biostatistics, Non-clinical, Medical Affairs, Marketing, Legal, ... to internal and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key internal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining ... us? The Position This role provides strategic and tactical support to the Director , Strategic Advisor & Supplier Diversity Lead within NNI Business Solutions (NBS).… more
- Genmab (Plainsboro, NJ)
- …will report to the Director , Programming, and work closely with Data Management , Clinical Programming, Statistics, Medical Writing, and other functions as ... our purpose.The Role & Department As a Senior Programming Associate or Programming Manager, you will be in the...and adherence to standards, and ensuring well-structured, high quality data summaries for internal decision making and reporting to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …improvements and seek agreement through consensus management . Relationships Reports to an Associate Director / Director within the NNI Procurement Team ... managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining… more
- Tris Pharma (Monmouth Junction, NJ)
- Associate Director / Director , Analytical Research and DevelopmentMonmouth Junction, NJ Analytical Development, R&DDescriptionTris Pharma, Inc. ... our Monmouth Junction, NJ headquarters has an immediate need for an experienced Associate Director / Director , Analytical Research & Development. Job Title… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …EEO Investigations role will work under the supervision of EEO Investigators and Associate Director EEO Investigations to assist with and conduct EEO ... Relationships The Senior Specialist, EEO Investigations role reports directly to the Associate Director EEO Investigations and assists with and conducts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Development on Project Teams. Responsibilities Study Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data ... of trial, clinical trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input on ICF creation;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as the principal functional expert and advisor for implementation and ongoing management and maintenance of the Company's global HRIS system (ie, SAP ... various downstream applications.Provide expertise on best practices, system integrations, data migrations, and technical configurations.Stay updated on industry trends,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …plans for specific categories under the direction of the head of category management , for the creation, execution, tracking of strategies. Includes working under a ... in managing multiple complex and competing priorities simultaneously. Proven project management and strategy skills. Is experienced in leading complex initiatives of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(ICFs), for assigned product(s)Authors or oversees the development of the Safety Management Plan for assigned product(s)Independently evaluates safety data of ... Investigator's Brochure, aggregate reports (DSUR/PLL), Prescribing information, Company Core Data Sheet (CCDS), Risk Management Plan(s) (RMPs)Collaborates with… more
