- Novo Nordisk Inc. (Plainsboro, NJ)
- …affiliate, and/or in collaboration with global colleagues. Relationships Reports to the Associate Director Product Quality . Regularly interfaces ... Sample Operations with their Must Win Battles and key business decisions Product Quality : Evaluates, and dispositions temperature excursions of sample … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe incumbent will be responsible for serving as the quality representative for, and providing quality oversight of, contractors performing ... activities supporting the production of clinical supplies with focus on drug product . Additionally, experience in medical device and/or combination products would be… more
- Catalent (Manassas, VA)
- Associate Director , Regulatory Affairs Position Summary: Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry ... committed to a Patient First culture through excellence in quality and compliance, and to the safety of every...consumer and Catalent employee. The primary duty of the Associate Director , Regulatory Affairs is to support… more
- Merck & Co. (Rahway, NJ)
- …This position will be responsible for applying their knowledge of product and process development in the (bio)pharmaceutical and/or medical device industries ... tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position interacts extensively with… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Associate Director , Global Strategy & Investigations Owner/Lead as part of the ... and investigations lead / owner for a best-in-class high volume marketed CAR-T product as part of a multi-site global manufacturing network. This individual is… 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 ... 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Aequor (Newbury Park, CA)
- …in what we do. Detail oriented, to be able to monitor data quality . Comfortable learning new systems/processes. Someone who is able to follow instructions/guides, ... understands the importance of details, since we work so much with monitoring Data Quality and someone who is able to communicate clearly with internal and external… 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)
- …improvements and seeks 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
