- 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)
- …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)
- …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)
- …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)
- …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)
- …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)
- …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)
- …Are you ready to maximize your potential with us? The Position The Associate Director will be the lead who is responsible for ensuring that all aspects of ... the organization and contact volume grows. Relationships Reports to the Sr. Director , Patient Support Solution Quality/Safety Associate Director . Interacts with… more
- Genmab (Plainsboro, NJ)
- …and growing organization? At Genmab, we're seeking a Senior Director , Strategic Planning & Effectiveness to drive cross-functional communication, alignment ... enhance efficiency and productivity across the organization.Collaborate with legal and compliance teams to ensure adherence to all regulatory requirements and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the appropriate use of data across the enterprise, in partnership with Legal, Compliance , Privacy and other critical functions. The Director will help integrate ... maximize your potential with us? The Position The Associate Director , Data & Analytics Governance is responsible for the...drive data and analytics governance Ensure data privacy and compliance , working closely with Legal, Compliance and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Access), Brand Marketing, Training, Market Access & Public Affairs, Trade, Legal, Compliance , Finance, HEOR, and Market Research. The position has high exposure to ... in order to accomplish objectives. Relationships Reports to the Executive Director , Patient Support Solutions. Key internal relationships include brand marketing,… 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
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.The RoleGenmab is searching for an experienced Director , Global Clinical Drug Supply to be part of Global Clinical Drug Supply ... forefront of bringing medicines to cancer patients and other serious diseases. Director , Global Clinical Drug Supply will work in partnership with several internal… more
