- Novo Nordisk Inc. (Plainsboro, NJ)
- …the organization and contact volume grows. Relationships Reports to the Sr. Director , Patient Support Solution Quality /Safety Associate Director . Interacts ... Program Management team to ensure vendor compliance with all quality /safety requirements; educates on process requirements Partners with compliance and Program … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and proficient in creation of process maps preferredExperience working with Quality Management systems preferredExperience with requirements related to global ... Director , Development SOP Management Join a...Authorship and Review Maintain a close working relationship with Quality Assurance and participate in the Company Global SOP… more
- Genmab (NJ)
- …our best, and authentic is essential to fulfilling our purpose.The Role:An Associate Director , Data Management is operationally responsible for the oversight of ... Clinical Data Management activities related to the effective planning, and timely...quality and reliable clinical trial data. The Associate Director DM will provide oversight to ensure end-to-end data… more
- Merck & Co. (Rahway, NJ)
- …network to enable process and formulation development.- In this position the SMAR&D Director will set guidance, lead activities, and develop a team whose roles ... and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing...innovative ways to achieve results.Nature and Scope of Position:The Director reports to the Executive Director of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ensuring the quality of PM activities including: communication, planning and management of schedule, budget, scope, issue risk management , and quality ... and Corporate Functions. They are responsible for ensuring consistent and effective management of approved Global and Regional IT projects and optimized PM resource… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Merck & Co. (Rahway, NJ)
- …accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary Leads the development and management of DSI's local and global Strategic PV Partnerships and contracts including ... and proactively drive operational excellence and continuous improvement. Oversees the management of Global PV Regulatory Intelligence (PVRI) and dissemination across… more
- Merck & Co. (Millsboro, DE)
- …(USDA, DEA, DNREC, etc.) of animal facilities and program reviews is required.PurposeThis Associate Director will report to the Site Quality Head/ Director of ... compliance with all federal and state regulatory requirements for animal welfare, management of controlled substances, quality control testing according to GMP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …supporting documents and evidenceSupport with implementing and ensuring global DBMA quality standards for Change requests IT Vendor Oversight and ManagementManaging ... readiness, cutover planning and execution, and post-go-live supportAdvocate change management within CSPV department by assessing org impact, proactively… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a collaborative work culture, including direct partnership with the Operations Director (s) Stakeholder Management : Build strong internal and external ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- Merck & Co. (Rahway, NJ)
- …multiple sites, managing regulatory audits, internal quality and safety audits, quality notices, CAPA management as the business area representative, as well ... track internal compliance metrics and report the observed trends to senior management .Provide regulatory support by preparing or reviewing high- quality CMC… more
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.The RoleGenmab is searching for an experienced Director , Global Clinical Drug Supply to be part of Global Clinical Drug Supply ... ability to exercise their skills and knowledge on process management & improvement, strategic & risk management ...bringing medicines to cancer patients and other serious diseases. Director , Global Clinical Drug Supply will work in partnership… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring external-facing… more
- Merck & Co. (Lower Gwynedd, PA)
- …Metabolism, and Bioanalytics (PDMB) Regulated Bioanalytics Department is seeking a Senior Director to lead the Regulated Robotics & LIMS team within the Exploratory ... vaccines and enable late-stage clinical trials through the generation of timely, high- quality regulated bioanalytical data. As the AdVAnce facility will not be fully… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global Clinical Study ... study and post-marketing protocols and the Clinical Study Oversight Plan, day-to-day management of DS Safety Notification Letter (SNL) System and oversee TMF… more
- Tris Pharma (Monmouth Junction, NJ)
- …have an immediate opening for a Head, Medical Science Liaisons (MSLs) / Director , Medical Training for our Pain division. This is a field-based position that ... ability to travel over 50 %.Head, Medical Science Liaisons (MSLs) / Director , Medical Training, Pain therapeutic space is responsible for field leadership of… more
- Genmab (NJ)
- …of all aspects of clinical development) working closely with the Medical Director and other cross-functions to provide high- quality and timely ... of the clinical development plan (CDP) Author components with Medical Director and reviewer of clinical and regulatory documents and registration dossiers… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... difference? The Position The Associate Director , Research Partnerships (RP) is responsible for developing and...RWE generation and dissemination through research partnerships Ensure the quality and validity of real-world evidence and ensure that… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... difference? The Position The Senior Director of CMR Knowledge & Technical Advancement (KTA) Department...of CMR Learning Support Partners, technical trainers and knowledge management staff. Closely partners with line leaders, Global Development… more
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