- Merck & Co. (Durham, NC)
- Job Description- The Associate Director of Quality Systems provides leadership, focus, and governance to the Hilleman site in the following Quality ... Management, Annual Product Review Authoring, Quality Risk Management, and Quality Council), the Associate Director will be responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cross-functional team resources, issues, risks as well as achieving overall project level quality metrics. An ideal Associate Director , Program Management ... other research areas centered around rare diseases and immune disorders. Summary The Associate Director , Program Management is a senior position responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for ... Supplements (PAS, CBE-0, CBE-30), Annual reports, Lot Distribution Reports, Biological Product Deviation Reports, and Drug Listings. Ensures that CMC documentation… more
- Merck & Co. (North Wales, PA)
- …execution for successful delivery across various teams and vendor partners to meet product line objectives with high quality , timeliness, and within budget / ... drives results.Reporting to the HH IT US Data Services Product Line Leader, this role will be responsible for...data products. The role influences and ensures timely and high- quality value delivery across all aspects of the data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval ... for assigned project(s).Strategize and plan for FDA meetings for assigned product . Liaise, negotiate and orchestrate meetings with FDA. Prepare internal meeting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics ... vendor management relationship and governance. Responsible for Strategic Application product roadmaps to meet business objectives.Lead the definition of solutions… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to meet smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate ... or More Years Extensive experience in project management, process, product , and/or analytical development activities and pharmaceutical/oncology project development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position ... Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes Processes and Best Practices: Reinforces labeling best… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of statistical activities; collaborates closely with data manager to ensure high quality data.Drug Development Strategy: Provides input to multiple aspects of the ... sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight: Review CRO/vendor proposal and budget.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical programmer.Drug Development Strategy: ... sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight: Review CRO/vendor proposal and budget.… more
- Insmed Incorporated (San Diego, CA)
- …for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Associate Director , Quality Assurance - Analytical,GMP has ... approval of GMP analytical records. Will also provide QA support for GTx Quality Control laboratories. This position is onsite/hybrid and based in San Diego,… more
- Eisai, Inc (Nutley, NJ)
- …system environment, using technical tools and utilities, performing complex product customization, and developing implementation and verification procedures to ... root cause of issues creating the best solution for Eisai considering quality , cost, and speed requirements.Strong technical knowledge of systems and applications… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop new ... and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key internal stakeholders… 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)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, ... and inclusive work environment.Essential Knowledge, Duties & Responsibilities for the Director Include:Sterile drug product development concepts, tools, and… more
- Eisai, Inc (Raleigh, NC)
- …your profile, we want to hear from you. Essential Functions Overall leadership of the Product Quality QC Biologics team. US staff are both remote and based out ... to ensure creation and maintenance of reference standards to support product portfolio.Responsible for developing and maintaining strategic relationships with other… more
- Eisai, Inc (Nutley, NJ)
- …and make a difference. If this is your profile, we want to hear from you. Director , Global RWE & Data Science sought by a pharmaceutical company in Nutley, NJ. Assess ... that address issues such as payer challenges, impairments in quality of life and patient well-being, and gaps in...pharmaceutical industry experience in the job offered or as Associate Manager. Also requires 5 years of experience with/using… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …improvements and seek agreement through consensus management. Relationships Reports to an Associate Director / Director within the NNI Procurement ... and Strategic Sourcing activities. This position will ensure the acquisition of high- quality goods/services at the best possible prices by negotiating and monitoring… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for operational improvements and seek agreement through consensus management.RelationshipsReports to an Associate Director / Director within the NNI ... and Strategic Sourcing activities. This position will ensure the acquisition of high- quality goods/services at the best possible prices by negotiating and monitoring… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …operations, marketing and compliance. Relationships This role reports to the Associate Director -Patient CRM Product Owner. Collaborates cross-functionally ... Direct vendor engagement and collaboration, maintaining adherence to project objectives and quality benchmarks Curate, manage, and expedite the product backlog,… more
