- Novo Nordisk Inc. (Plainsboro, NJ)
- …FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....of the resources within NACD. Relationships Reports to Snr Director of Clinical Strategy and Business Operations within Operational… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and productivity.Key Responsibilities Co-Lead Deviation Investigations: Collaborate closely with the Quality Associate Director to co-lead the deviation ... in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, 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. (Basking Ridge, NJ)
- …of statistical activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides input to multiple aspects of the ... scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.- CRO / Vendor Oversight: Review CRO/vendor proposal and… more
- Merck & Co. (Rahway, NJ)
- Job Description Associate Director , Engineering, Development and Integration - Rahway, NJ :Own and manage the product feature through the duration of the ... product lifecycle.Define the overall product feature vision and strategy, with a keen focus on value, business outcomes, and user experience.Make product … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …FDA reportability. Serve as the back-up Pharmacovigilance responsible person for NNI. PRODUCT COMPLAINTS: Ensures high quality medical and technical product ... education and collecting data to support efficacy and new product development, CMR is involved. The one thing that...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Rahway, NJ)
- …diverse and inclusive work environment.Knowledge, Duties & Responsibilities for the Director Include:Oral drug product development concepts, tools, and ... and scaling up the formulation, device, and manufacturing process. Driving drug product design from the bench top to the Good Manufacturing Practice (GMP)… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Shared Services Marketing Operations Director is responsible for driving operational excellence of APEX shared services. This role will create ... engagements and moderating speaker events. It is the responsibility of the Director of Shared Services Marketing Operations to adapt and expand these services… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- Insmed Incorporated (Bridgewater, NJ)
- …the development and communication of HEOR evidence to demonstrate the value of Insmed's product (s). The Associate Director will work closely with HEOR team ... in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , HEOR is a significant contributor to… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director of Biostatistics is responsible for the statistical ... aspects for complex clinical trial(s) or indication product line. This role leads the protocol statistical section...and reporting of clinicals.Manage the timelines and oversee the quality of statistical analyses by CRO or internal teams.Undertake… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of research and strategic partnership contracting agreements. In collaboration with the Associate Director , the Associate Manager will support CMR's ... across internal and external stakeholders Relationships This position reports to an Associate Director overseeing the contract management function of the CMR… more
- Merck & Co. (Durham, NC)
- …, and daily operations;Ensure that Shift(s) objectives are achieved while reliably supplying quality product at a competitive cost consistent with our Company, ... and business plan; receives guidance and oversight from Operations Associate Director and Director ;Interprets client...Support Tier.- Exercise judgment and decision making to ensure quality product is reliably produced while managing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position Manage and oversee all assigned projects/products/processes. Assist the Director / Associate Director in assuring Novo Nordisk compliance ... regulatory agencies. Supervise designated personnel. Relationships Report to the Director / Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Canada), and escalating quality concerns. Relationships This position reports to the Associate Director of GXP Oversight and/or Head of GXP Support. Multiple ... across various topics, such as clinical trial management, deviation handling, and product quality Develop, execute, and maintain sufficient training to support… more
- Merck & Co. (Durham, NC)
- …to have the safest and most compliant operation around the network.EMSS has an Associate Director opening for the Teknika maintenance and Engineering team. The ... human resources activities while ensuring a safe work environment with optimized product quality and manufacturing processes and regulatory compliance. GENERAL… more
- Merck & Co. (Durham, NC)
- …support for business area applications. Working Relationships Reports to the Associate Director Manufacturing Automation Frequent interaction with employees from ... embrace an empowered team culture including significant interaction with manufacturing, quality , IT, and engineering groups. - The Senior Specialist for… more
