- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global Clinical Study ... decisions where appropriate and escalate any complex problems to the Director , Clinical Study Startup.This position requires strong organization and interpersonal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Director , Development SOP Management Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative ... centered around rare diseases and immune disorders. Job Summary: The Director , Development SOP Management is responsible for providing strategic direction, planning,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global Pharmacovigilance (PV) service ... and aggregate reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …operations and activities for all US (multi-state) and Canada regions, ensuring compliance with company policies and statutory regulations. This position will be ... and liaise with Human Resources, Finance & Accounting, Tax, Compliance and Legal team members to ensure compliance... Compliance and Legal team members to ensure compliance with all relevant regulatory, accounting, tax and internal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …business teams introducing improved systems experience, cost savings, and compliance . - Stakeholder CollaborationAdvocate for the Global HRIS and collaborate ... with respective regional leads to align and incorporate system maintenance controls.Collaborate across each functional area of HR working with COEs, HR and Business leaders to understand their specific requirements building strong relationships based on trust,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by managing labeling development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to Core Data Sheets for ... as well as for the review of country labeling deviations.Ensure Compliance with Labeling Regulations and Guidance: Researches applicable Health Authority labeling… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration ... with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)Study Planning and Execution: Provides input on major milestones of trial, clinical trial plan and contingency planning; Analyzes and updates management on potential risks to study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with all applicable Health Authority (HA) regulations and guidelines, ... may manage assigned staff, partnering with the Global Labeling Operations & Compliance group and across the cross-functional and cross- regional representatives on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems and architecture. Advocates for good architecture and design practices and compliance in all relevant areas. Assists IT and business leadership in ... projects. Performs regular solution/code reviews with technical teams to ensure compliance with standards. Leads in process improvement and develops procedures to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with all applicable Health Authority (HA) regulations and guidelines, ... may manage assigned staff, partnering with the Global Labeling Operations & Compliance group and across the cross-functional and cross- regional representatives on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as usual.Leads or assists in the tracking and investigation of quality and compliance issues OtherReview and update of DMA ProceduresMaintain compliance with ... relevant policies and proceduresSupport the investigation and resolution of complex, cross-functional issues using strong problem-solving abilities Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execution, closely with the Business and other cross functional teams (eg Legal, Compliance , IT, etc.) for both US and Global engagements. Partners closely with ... Japan and Europe on sourcing strategies, contract negotiations for terms and conditions as well as pricing for optimal leverage and synergies- Act as the Subject Matter Expert for Strategic Sourcing's e-Procurement suite of tools (eg iSource, iRisk, iAnalyze… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Department At Novo Nordisk, we're committed to building the best Ethics, Compliance & Privacy (ECP) team in the pharmaceutical industry. Operating at the highest ... on new procedures, to auditing against local and corporate policies, to reporting compliance -related issues, ECP keeps us accountable every step of the way as we… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring external-facing ... budgeting guidance. Collaborating with cross-functional teams to ensure contractual compliance and driving continuous improvement. Works closely with suppliers to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and therapeutic areas (TA), under the guidance of the Associate Director , GOMA Scientific Engagement.Contribute to the management and execution of activities ... community to enable flow of information from/to medical community. Assists Associate Director , GOMA SE in developing Scientific Engagement strategies for the TA, in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a Publications Systems and Operations Intern to work closely with the Director of Publications Operations to optimize department resources for delivery of ... will be responsible for auditing the system, running metrics, and ensuring compliance with SOP and good publications practices. They should be technologically savvy… more
- Merck & Co. (Rahway, NJ)
- …dedicated colleagues while developing and expanding your career. - The Senior Director (Senior Principal Scientist) has primary responsibility for the planning and ... particular focus on obesity and obesity-related metabolic disorders. - The Senior Director will manage the entire cycle of clinical development, including study… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... as well as advancing a culture of scientific excellence, GMP and compliance mindset and collaboration with various partners and stakeholders in development.The … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Description Director -QP2-IO We are seeking an experienced talented scientist to join the - Quantitative Pharmacology and Pharmacometrics - - ... Immune/Oncology - (QP2-IO) - team in the role of Director . QP2-IO team is part of the Global Clinical...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director , Value & Implementation (V&I), Global Medical and Scientific Affairs (GMSA) is accountable for the development and execution of ... TA dedicated global and regional directors and associate directors. The Executive Director , Value & Implementation (referred to as EDMA) engages with global… more
