- Merck & Co. (Rahway, NJ)
- …Development (BAR&D) seeks a driven leader to advance and commercialize complex biotherapeutics.The Director of Compliance , reporting to the Senior Director ... inspections.Address audit findings and identify trends to enhance laboratory compliance .Conduct laboratory investigations and collaborate with stakeholders to implement… 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)
- …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)
- …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)
- …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
- Merck & Co. (Rahway, NJ)
- …breakthrough science that radically changes the way we approach serious diseases. --The Director will report to an Associate Vice President in the Oncology Clinical ... Research Group. Under the guidance of a supervisor, the Director has primary responsibility for the planning and directing of clinical research activities involving… 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 DescriptionDirector, Discovery Process Chemistry, RahwayDescriptionThe Director , Discovery Process Chemistry is responsible for managing a portfolio of projects ... API supply during this period.-Nature and Scope of PositionThe Director reports to the Executive Director of...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:Reporting to a Technology Director or Associate Director in Global Engineering Solutions (GES), the Associate Director ... of Large Molecule, Small Molecule, and Animal Health work.The Associate Director participates in project activities ranging from business case development through… more
- Merck & Co. (Rahway, NJ)
- Job Description Director of Customer Knowledge Capability & Patient Insights Engine (PIE) We are seeking a Director of Customer Knowledge Capability in the ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs the Director /Principal Scientist in Devices and Drug-Device Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the ... Director of Device Regulatory Affairs for Autoinjector Development Programs....regulatory activities for Devices and Drug-Device Combinations (DDDC), ensuring compliance with domestic and international regulations and guidance. This… more
- Merck & Co. (Rahway, NJ)
- …network to enable process and formulation development.- In this position the SMAR&D Director will set guidance, lead activities, and develop a team whose roles ... and solving problems in innovative ways to achieve results.Nature and Scope of Position:The Director reports to the Executive Director of SMAR&D and will lead a… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Overview:-We are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in supporting ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
