- 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
- 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 ... areas centered around rare diseases and immune disorders. Summary The Associate Director , Program Management is a senior position responsible for effectively… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Associate Director , Global Medical Affairs (GMA) Oncology- Medical Content ... is responsible for execution of global scientific and training deliverables. The Associate Director develops and executes Medical Content and Training plans… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible for ... producing scientifically accurate, high- quality clinical regulatory documents while adhering to regulatory guidelines....and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess… 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 ... that CMC documentation is complete, well organized, scientifically sound, of a high quality , aligned with the current regulations, and presented in a manner that… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Associate Director of ERP Applications is responsible for overseeing and ... from all Daiichi Sankyo regions in scope.- Responsible for developing high quality solutions based on Functional Design documents. Perform system customization and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of ... projects are delivered on time, within budget, and meet high- quality standards. Ensure effective communication and issue resolution.Communication and Collaboration:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for ... Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before… 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: ... Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight: Review… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes Processes and Best Practices: Reinforces labeling best ... practices at cross-functional meetings. Assists in the development of Standard Operating Procedures (SOPs) and process improvements. Follows agreements with external partners.Department Coordination: Builds cross-functional and cross-regional… 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 ... development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight: Review CRO/vendor proposal and budget. Establishes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsibilities. Leads complex supplier negotiations and commercial contracts for quality and value creation. Enhances the procurement capability by helping ... to develop and deliver processes, training, procurement technology and knowledge management tools. Closely partners with senior Business stakeholders to design optimal processes and sourcing solutions that meet the business' objectives and produce synergies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics ... Services, Project Management and Operational Management. Develop a strong, positive strategic business partnership with the global R&D business and Global IT functions of Daiichi Sankyo. As a trusted partner, provide oversight of technical and solutions… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior ... CMC Lead regarding the activity status and potential critical issues, or to the governance bodies. Responsibilities - Accountability to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case no Sr CMC Lead is established, take… 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 ... of pharmaceutical applications for the company's growth, thereby accomplishing corporate goals.ResponsibilitiesDevelop and implement US regulatory strategy for assigned project(s).Strategize and plan for FDA meetings for assigned product. Liaise, negotiate and… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Omnichannel Customer Engagement Strategy Associate Director will be responsible for partnering with key areas within our Company to help shape ... to healthcare professionals and consumers. The Omnichannel Customer Engagement Strategy Associate Director reports into the US Oncology Omnichannel Strategy… more
- Merck & Co. (Rahway, NJ)
- …Dosage (Non-Sterile) team at the FLEx Center in Rahway is looking for an Associate Director - Process Engineer to lead clinical supply manufacturing, scientific ... will:Lead and strategically plan on-the-floor batch manufacturing to ensure safety and quality of clinical supplies to augment and accelerate our products.Manage a… more
- Merck & Co. (North Wales, PA)
- Job DescriptionLead and develops the necessary processes to ensure high quality individual case and aggregate safety reporting. Interpret PV regulations related to ... of safety database.Provide expert guidance on policies and procedures related to quality and compliance of expedited and periodic reports.Interpret FDA and EU… more
- Novo Nordisk Inc. (Boulder, CO)
- …are driving change. Are you ready to make a difference? The Position The Associate Director , Process Chemistry will be responsible for the design, development ... development and scaling of small molecules, oligonucleotide intermediates and API's. The Associate Director is expected to implement novel strategies towards… more
- Merck & Co. (North Wales, PA)
- …data capabilities and data products. The role influences and ensures timely and high- quality value delivery across all aspects of the data value chain including but ... Data Mastering, Data Governance including but not limited to Data Marketplace, Data Quality , Data Risk Management c) Value Realization with use of these Data… more
