- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the ... Technical Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide… more
- Eisai, Inc (Nutley, NJ)
- …we want to hear from you. Job Summary: As the Americas IT Security and Compliance Director , you play a pivotal role in ensuring the organization's adherence to ... security, regulatory, and compliance standards. Collaborating with business and EIT stakeholders, you...stakeholders, you promote awareness of best practices and strengthen compliance with GDPR, HIPAA, CSL, and other relevant security… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …part of the Compliance organization and will report directly to the Director , Compliance Training, Policy & Communications. This position will be responsible ... for developing unique themes, imagery, etc., under the direction of Director , Compliance Policy, Training and Communications.Project manage various teams… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …role that is responsible for QA GMP activities pertinent to the overall compliance state of DS drug substance, drug product and packaging manufacturing sites of ... of internal and external GMP manufacturing organizations.Ensures a satisfactory regulatory compliance level for these organizations for local and global markets.… more
- Merck & Co. (Rahway, NJ)
- …and our neighbors are not impacted.This role, reporting to the Executive Director of Environmental Compliance , Sustainability & Stewardship CoE will manage ... Job DescriptionPosition Description: Director , Product Stewardship Our Global Safety & Environment...our company while driving improvements and alignment for regulatory compliance worldwide.Responsibilities: Manage and provide leadership to a team… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Clinical Operations (GCO) Procedural Ownership and Life Cycle ... and policies, and meet applicable ICH and GCP standards. The Associate Director will also be responsible for the creation, management, and documentation of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary Director , Global Medical Affairs Oncology Publications works with Cross Functional Team ... authorship agreements, financial disclosures and author approvalsEnsures documentation of compliance with authorship and publication guidelines as stipulated by the… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, 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. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. Summary: The Associate Director , Field Medical Training will be responsible for the development, implementation, ... Workers requiring therapeutic knowledge of the Daiichi Sankyo portfolio. The Associate Director , Field Medical Training will have a variety of responsibilities that… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Director , Global Clinical Operations (GCO) Clinical Trial Operational Risk & Oversight ... selection process.Ensures appropriate oversight from a clinical trial risk and compliance standpoint and establishes a comprehensive interface for risk and issue… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction of the Senior ... Director , GMA Oncology (Global Medical Affairs team lead for...as scientific symposium and medical congresses, within legal and compliance regulations.Collaborates across functions to support GMA MI&E activities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …writing of global standard operating procedures; Monitors and enforces compliance of standard procedures and processes.People Management: Has administrative ... responsibilities for recruiting, retaining, developing, and managing employees. Identifies training needs of staff, not limited to direct reports, and implement the trainings. Leverages manpower and talents across Regions to maximize efficiency. Mentors or… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, NJ)
- …authorities. Represents DS in key interactions with Health Authorities. Ensures compliance of DS programs with regulatory requirements for diagnostics and ... devices.Provide strategic input on key development documents, clinical protocols, study reports, IBs, INDs, CTAs, IDEs, SRDs, PMAs and labeling for drug and diagnostic products. Provides guidance on planning, writing, review of key dossier documents for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the development, maintenance, ... (ex: Biomarker Data, Medical Devices Data, etc.) are effectively developed in compliance with CDISC / SDTM industry standards for diverse DS Programs operating… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, NJ)
- …site contacts and on-site visits to monitor study sites protocol execution and compliance to applicable DS SOPS and procedures -Enable ways for GPTs and Study ... Management Teams to have conscious inclusion trainings, and tools for investigative sites to support their efforts in reaching diverse communitiesPeople Management: May manage staff which would include oversight, training and mentoring of employee and/or… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary:The Director , Global Medical Affairs (GMA), Gyn Oncology, under the direction of the ... Senior Director , GMA Oncology (Global Medical Affairs team lead for...decks, and other internal training resources, within legal and compliance regulations. Provides training or communication of emerging data… more
