- 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)
- …other research areas centered around rare diseases and immune disorders. Summary The Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the ... Senior Director , GMA Oncology ADC (Global Medical Affairs team lead...as scientific symposium and medical congresses, within legal and compliance regulations.Collaborates across functions to support GMA MI&E activities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …quality listings, SAP, DM plan, Reviews patient population and protocol compliance for consistency with study strategy, develops biomarker strategy in collaboration ... with TMCP, collaborates with external KOLs to refine study plans; Prepares and participate in regulatory agency meetings, if applicable.Study planning and execution: As CSL for Phase 2 studies: Provides input on major milestones of trial, clinical trial plan… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary: The Associate Director , Regional Marketing Conventions & Field Programs will be responsible for ... more, while ensuring adherence to DS policies and procedures. The Associate Director , Regional Marketing Conventions & Field Programs is responsible for managing the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Associate Director FP&A position is an integral part of the finance team supporting ... any variances and implications on business performance. Works with Director of FP&A to streamline and improve reporting to...as well as Actuals reporting and analysis while ensuring compliance with alliance policies and procedures. Act as Alliance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical Affairs' ... collaborative studies. Ensure projects align with strategic goals and compliance standards from initiation through completion.Operational Strategy: Develop and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for assigned compound under the supervision and leadership of the Executive Director of Medical Research and Strategy, US Oncology Medical Affairs (USOMA). Develops ... communications and medical information response documents within legal and compliance regulations. Leads internal stakeholder medical education activities related to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, ... regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US, International… 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)
- …to build a phase appropriate quality system that supports quality and compliance of Good Clinical Laboratory Practices and Good Laboratory Practices. Proactively ... identifies compliance risks impacting research unit across DSG, and assures...medic, and other local authorities as necessary to address compliance relevant matters and lead any remediation efforts. ResponsibilitiesLeads… 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)
- …responses submitted to health authorities globally with respect to data standards, compliance , etc. May represents the function at health authority meetings. Reviews ... practice, especially with respect to oversight of vendor performance. Oversees compliance with standard procedures and processes. Leads the development and… 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)
- …quality listings, SAP, DM plan, Reviews patient population and protocol compliance for consistency with study strategy, Develops biomarker strategy in collaboration ... with TMCP, Collaborates with external KOLs to refine study plans; Prepares and participate in regulatory agency meetings, if applicableStudy planning and execution: As CSL for Phase 2 studies: Provides input on major milestones of trial, clinical trial plan… 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)
- …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)
- Job DescriptionThe Clinical Director (Principal Scientist) has primary responsibility for planning and directing clinical research activities involving ... compounds in Immunology. With a focus on late-stage development, the Clinical Director will manage the entire cycle of clinical development, including study design,… more
- Merck & Co. (Rahway, NJ)
- Job Description Position Description: Associate Director , Lab Management Our team in Rahway, New Jersey, is seeking a strong leader who is passionate about lab ... management and operation support. The Associate Director of Biologics Process Research and Development (BPR&D) is...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Rahway, NJ)
- …Investigations in our OGC (Office of General Counsel) organization, the Director , Global Investigations responsibilities include acting as a confidential and ... Europe.Preferred candidates will have a strong working knowledge of regulatory and compliance laws, including the US Foreign Corruption Practices Act (FCPA) and… more
- Merck & Co. (Rahway, NJ)
- …advancing our company's contribution to global medical innovation. Job Description: The Associate Director , IT SOX Program Manager plays a key role within the IT ... Risk & Compliance Programs function. Responsible for the end-to-end oversight of...and execution for one of our company's most critical compliance programs. The individual partners cross-functionally with divisions across… more
