- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …support the leader in the development and implementation of the Compliance Monitoring Program, specifically Federal healthcare laws, FDA promotional guidelines, and ... laws, guidelines, and regulations. This individual will partner with members of the Compliance team on critical projects and provide support; will be responsible for… more
- Merck & Co. (Rahway, NJ)
- …Code of Conduct and the Ethics Ambassador Program, developing ethics and compliance training workshops and communications, and managing other key initiatives in ... candidate's ability to work effectively with colleagues within the Ethics and Compliance Office (ECO) and across divisions, functions, and regions. This position… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director, ESQL is responsible for all activities at the External Entity (EE) site associated with the manufacturing of company products ... to all applicable regulatory requirements, regulatory filings and company policies.The Associate Director also ensures that effective and robust Quality systems are… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Principal Programmer leads the statistical programming activities for multiple and/or large/complex late stage drug/vaccine clinical ... of focus include (1) the assurance of deliverable quality and process compliance , (2) effective deliverable development utilizing global and TA standards that… more
- Merck & Co. (Rahway, NJ)
- …the Operations Specialist include the following:The Operations Specialist role at the Associate Specialist level will serve as a process team member supporting the ... and innovation.They will collaborate closely with the development engineers & chemists, compliance representatives, and other team members to ensure the quality and… more
- Merck & Co. (Rahway, NJ)
- …of the trial.Performs clinical study site management/monitoring activities in compliance with ICH-GCP,-Sponsor SOPs, Local Laws & Regulations, Protocol, Site ... site performance.Identifies, assesses and resolves site performance, quality or compliance problems and-escalates per defined CRA Escalation Pathway as appropriate… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Associate Director, Omnichannel Marketing and Media position reports to the Senior Director, Omnichannel ... Marketing (HCP and Patient). The associate director will also partner closely with key internal...across target audiences as well as ensure regulatory/legal and compliance requirements are met.This role requires strong marketing and… more
- Merck & Co. (Rahway, NJ)
- …forecastStrong partnership and alignment with EIT Finance and IT PMOEnsure compliance with IT financial controls and standardsQualifications, Skills & Experience: ... The ideal candidate will have strong analytical skills to conduct ad-hoc analysis and provide insights to support proactive planning of portfolio, operational budget and contract reviews, approvals and renewals.- The incumbent will be responsible for ensuring… more
- Merck & Co. (Rahway, NJ)
- …reliance on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the BDC ... and adhere to CFR, GMP, and data integrity regulations to ensure compliance with regulatory requirements.Develop and maintain SDLC documentation.Actively work in a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director, Global Oncology Clinical Development (GOCD) Functional Excellence supports ... management and implementation planning, for GOCD non-project related initiatives. The Associate Director, GOCD Functional Excellence must have excellent verbal and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction of the ... such as scientific symposium and medical congresses, within legal and compliance regulations.Collaborates across functions to support GMA MI&E activities in order… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at ... quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal...management of CROs and 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and adherence to… 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)
- …direction and execute oversight of vendor delivery, to ensure compliance with the protocol, external/internal standards, applicable regulatory guidelines, policies, ... SOPs, and other relevant guidelines- Engages, under supervision, in vendor selection and contracting, including review and negotiation of baseline budget and timelines- Oversees budget management activities across the project duration- May participate in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …management sciences, and risk management tools and resources.- Risk Management Compliance Inspection Readiness Champion. Serve as member of Risk Management office ... to ensure risk management activities allow for effective preparation for inspections/audits. Serve a key support during Risk Management Inspections.Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and ensures that material is fully released prior to shipment to siteEnsures compliance with all domestic and foreign regulatory requirements but may seek line ... management support when necessary. Basic knowledge of Import/export requirements to the extent that there is overall recognition of potential global issues as regards import license requirements, shipment delays and is able to communicate the issues and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …matter expert in meeting or teleconferences with Health Authorities. Ensure compliance with international regulations. Ensure inspections readiness as well as ... direction and execute oversight of vendor delivery, to ensure compliance with the protocol, external/internal standards, applicable regulatory guidelines, Policies,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Management:Manage 3rd party vendor interactions to ensure they are following compliance with all DSI requirements and meeting all service level agreements.Analyzing ... and FMV process to comply with DSI Legal and Compliance requirements. Work closely with HCP Engagements to manage...to track HCP Speaker trainings and other activities as required. Compliance and Policy Adherence:Primary point of contact for the… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Value Access & Pricing will both develop and ... strategies and pricing policies; in collaboration with key regions/markets Ensure compliance with legal requirements- Collaborate and provides input to Clinical on… more
