- Eisai, Inc (Nutley, NJ)
- …a difference. 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 partners to deliver omnichannel and… more
- Merck & Co. (Rahway, NJ)
- …are seeking a highly skilled and experienced professional to join our team as an Associate Director for our Digital Forensics Lab. The Associate Director ... forensics lab, ensuring all activities are conducted efficiently and in compliance with legal and regulatory requirements. Manage and provide technical guidance… more
- Merck & Co. (Rahway, NJ)
- …that provides a high degree of technical and project management responsibility. The Associate Director - Process/Facility Engineering position will report to the ... infrastructure.- Responsibilities include the following:The process/facility engineer role at the Associate Director level will serve as a technical mentor… more
- Merck & Co. (Rahway, NJ)
- …to lead and support facility operations, process development activities, compliance investigations/change management, authoring of GMP documentation, and lead other ... overall success of the pilot plant. The Facility Lead position reports to the Director of Operations/Head of SSO Pilot Plant and the successful candidate will be an… more
- Merck & Co. (Rahway, NJ)
- …Coordinate & facilitate upskilling to embed critical capabilities (to support the PPS director conduit from HHDDA) on behalf of Global Oncology dept. (ie-L3, PIE, ... prioritization, new asset, portfolio considerations to support the PPS director /PRT LT partnership &-prioritization-- Support PPS team on facilitation of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder minimal guidance of the Senior Director or Director , Business Development Execution, the primary function includes coordinating various ... GRACS contractual obligations and commitments are met while maintaining regulatory compliance .Work closely with the Corporate Business Development, our Research &… 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 ... 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)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Value Access & Pricing will both develop ... for the assigned oncology asset(s). This person will report to the Sr Director , Global Oncology Value Pricing & Access, and will be responsible for providing… 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)
- …research 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)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director , Global Oncology Clinical Development (GOCD) Functional Excellence ... management and implementation planning, for GOCD non-project related initiatives. The Associate Director , GOCD Functional Excellence must have excellent verbal… more
- Merck & Co. (Rahway, NJ)
- …to GRACS.Primary activities include, but are not limited to:Reports to Executive Director or Associate Vice President, Therapeutic Area Lead.Develops worldwide ... the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and ... quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with...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)
- …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)
- …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)
- …research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head RDPVQA, ... and oversees multiple levels of direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global PV Quality teams located in… 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
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , Commercial Learning & Development, will be a key ... to understand training needs and translate into actionable and enriching associate learning curricula and fostering connections among commercial associates. This… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review study submission data package and ... ensure its quality and integrity.- Provide hands-on statistical programming support to regulatory submission and help submission team in quick turnaround in response to regulatory agencies. Responsibilities include: develop programming submission strategy,… more
