- Novo Nordisk Inc. (Plainsboro, NJ)
- …Key Opinion Leaders (KOLs), Healthcare Professionals (HCPs), and other stakeholders. The Medical Director will also assist the Senior Medical Director in ... education and collecting data to support efficacy and new product development, CMR is involved. The one thing that...Area in certain instances, at the discretion of Executive Director of Medical Affairs. Assists the Senior … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Oversees management and performance of CRO. Occasional interactions with CRO senior leadership as needed; Participates in creation of developmental and regulatory ... strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and...representative or IST leader on study team; Responsible before senior management for the creation and execution of development… more
- Merck & Co. (Rahway, NJ)
- …including oversight of regional roadmaps for major inline and key new product launches.The Executive Director , Customer Marketing and Business Execution reports ... to veterinarians, channel partners, pet owners and influencers. The Executive Director , Customer Marketing and Business Execution is expected to drive innovation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, ... 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)
- …Sciences (RaDS) value team in Our Company's R&D IT brings together product management, engineering, and data science expertise to enable data and technology ... change the course of human health. In the RaDS value team, the Product organization is responsible for implementing technology products and associated services to… more
- Merck & Co. (Rahway, NJ)
- …solid-oral small molecules to peptides, pediatric formulations, and devices. The Executive Director , as a senior member of the Global Regulatory Affairs ... expanding your career.The Chemistry, Manufacturing & Controls (CMC) Pre-approval Pharm Executive Director is accountable for managing a team of CMC professionals 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....ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …direction and leadership for the investigations management system. Working closely with the Quality Senior Manager, this position will ensure alignment with all ... Conduct risk assessments to prioritize investigations based on potential impact on product quality , patient safety, and regulatory compliance. Address recurring… more
- Catalent (Harman, WV)
- Position Summary The Director , Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... raw materials release, and compiling, trending and reporting key quality metrics for Senior Management review, and...and the release of drug substance and/or final drug product to support Phase I/II clinical trialsWork with clients… more
- Merck & Co. (North Wales, PA)
- Job DescriptionUnder general supervision of an Executive Director / Senior Director , the Principal Scientist / Director is responsible for developing and ... and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance with domestic and international regulations and… 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)
- …to meet 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...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 and at GCP strategic discussions.Support the Head of RD QA with Quality Reviews of respective product profile to ensure appropriate management review ... QA at the Development Leadership teams, as appropriate and as neededInteract with senior Oncology Franchise leadership teams to ensure Quality is consistently… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Director , QA Operations as part of the Quality team based in Raritan, NJ. ... Role Overview The Director of Quality Operations , CAR-T is...product , QA shop floor oversight of manufacturing operations, Quality Assurance review and approval functions, and QC laboratory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …customers. Our passion for helping people live better lives and our award-winning product pipeline can only be as effective as our ability to provide life-changing ... activities for the portfolio of mature brands. Relationships Reports to Executive Director , Mature Business Unit - Head. Interacts frequently in collaboration with… more
- Merck & Co. (Durham, NC)
- …and embrace an empowered team culture including significant interaction with manufacturing, quality , IT, and engineering groups. - The Senior Specialist for ... Job DescriptionPosition Description: Senior Specialist, Manufacturing Automation The Senior ...system(s) to ensure a compliant, reliable supply of the product and on-time project execution. Provide production shop floor… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …NNI to support our Cardiometabolic ambitions. Relationships This role reports to the Senior Director - Data Strategy and is accountable for actively ... Are you ready to maximize your potential with us? The Position The Senior Manager - Cardiometabolic Data Partner is responsible for partnering with the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across various topics, such as clinical trial management, deviation handling, and product quality Develop, execute, and maintain sufficient training to support ... 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
- Novo Nordisk Inc. (Pittsburgh, PA)
- …coordination with his/er Field Director . Relationships Position reports to Field Director / Senior Field Director . Serves as organization spokesperson on ... 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
- 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
