- Merck & Co. (Rahway, NJ)
- …to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on ... and solutions to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director of Materials and Biophysical Characterization is responsible for providing strategic and technical leadership for materials ... vaccines from discovery through development and commercial launch.The Executive Director reports to the Associate Vice President, Analytical Enabling Capabilities… more
- Merck & Co. (Rahway, NJ)
- …understanding of the regulatory environment, and a-vision to influence the regulatory environment.Nature and Scope of Position:The Director reports to the ... chemical and biochemical promcesses, parenteral, oral, and specialty dosage formulations.- The director should be well engaged with regulatory and industry… more
- Merck & Co. (Rahway, NJ)
- …to bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director selects, trains, and ... Job DescriptionThe Director of Biologics Potency in Analytical Research &...strong network internally and across the external academic and regulatory community is expected, as well as advancing a… more
- Merck & Co. (Rahway, NJ)
- …and implement robust SAP security policies, procedures, and controls.Ensure compliance with regulatory requirements and industry best practices.Manage ... and overall role administration. This role reports to Executive Director , SAP Platform Team. Primary Responsibilities: Leadership and StrategyProvide strategic… more
- Merck & Co. (Rahway, NJ)
- …requirements for solution design for planning, warehouse operations, distribution, ensuring compliance with market requirements as global regulatory requirements ... continue to evolve. Develops subject matter expertise within functional and technical teams in overall CTSM solutions and provides direction and guidance to drive ongoing configuration, enhancements, and integration effort. Service Management: Manage the total… more
- Merck & Co. (Rahway, NJ)
- …digital forensics lab, ensuring all activities are conducted efficiently and in compliance with legal and regulatory requirements. Manage and provide technical ... Job DescriptionAssociate Director - Digital Forensics Position Summary:-We are seeking...expert opinions or technical assistance as needed.Quality Assurance and Compliance :-Develop and implement protocols and procedures to ensure the… more
- Merck & Co. (Rahway, NJ)
- …with cross-functional development teams to enable pipeline decisions.- The Director , Biologics Analytical Research and Development (B-AR&D) is responsible for ... of candidates from the discovery interface, through first product registration.- -The Director will be directly responsible for a team of approximately 10-15… more
- Merck & Co. (Rahway, NJ)
- …Next) or other strategic frameworksGlobal experienceKnowledge of Company commercial, regulatory , and legal compliance policiesNOTICE FOR INTERNAL APPLICANTSIn ... Coordinate & facilitate upskilling to embed critical capabilities (to support the PPS director conduit from HHDDA) on behalf of Global Oncology dept. (ie-L3, PIE,… more
- Merck & Co. (Rahway, NJ)
- …and adhere to CFR, GMP, and data integrity regulations to ensure compliance with regulatory requirements.Develop and maintain SDLC documentation.Actively work in ... on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the BDC Pilot… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to… 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 ... educating end-users on compliance requirements. Additionally, you manage regulatory compliance activities, maintain accurate documentation, and evaluate new… more
- Eisai, Inc (Nutley, NJ)
- …customer journeys and strategies across target audiences as well as ensure regulatory /legal and compliance requirements are met.This role requires strong ... 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… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics ... communication/publication components of overall medical operating plan.The Sr Medical Director provides strategic development, planning, implementation, and oversight of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation ... of developmental and regulatory strategy; Drafts protocol profiles and sections of key...listings, SAP, DM plan, Reviews patient population and protocol compliance for consistency with study strategy, Develops biomarker strategy… 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, ... and enforcement of data standards, demonstrated knowledge of industry standards related regulatory requirements (CDISC), FDA & ICH, PMDA, EU & ICH, CRP and… 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, ... risk-based assessment for Distributors, co-partners, and affiliates. Liaise with Audit and Compliance team to ensure that GVP audits are planned, communicated and… more
- Merck & Co. (Rahway, NJ)
- …products.-- Providing labeling expertise and guidance to teams while ensuring compliance with applicable regulatory requirements- Serving as regulatory ... Affairs sub-teams to ensure delivery of labeling documents that meet quality and compliance standards and regulatory labeling requirements to support timely … more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Scientific Communications is a core member of Medical Strategy and ... implementation of global Medical Communications Strategy across regions. The Director will develop collaborative partnerships with the cross-functional Insmed team… more
