- Merck & Co. (Rahway, NJ)
- …Lab Lead will be expected to exhibit a mindset of safety and quality compliance, which will include following current Good Manufacturing Practices (cGMPs), and ... internal resources and academic or industrial partnerships.- In partnership with the Director of Chemical Engineering R&D, the Crystallization Lab Lead also plays 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 ... 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)
- …lives for a living. Are you ready to make a difference? The Position The Senior Director of CMR Knowledge & Technical Advancement (KTA) Department will serve to ... education and collecting data to support efficacy and new product development, CMR is involved. The one thing that...strategy they will provide valuable support and consultation to Senior Leaders in the Line of Business. In this… 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
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe Quality Director is the senior leader and decision maker for the Quality Department and Quality Management System. This position ... is ultimately responsible for the product quality received by the customer and...quality system integrity expected by the customer. The Quality Director is committed to relentlessly pursuing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …organization. Relationships The Director -Patient Centered Outcomes Research reports directly to a Senior Director within the CDSE RWE team. This is a US ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....to support optimization of access & reimbursement, clinical practice, product development and registration. The Director serves… 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....Are you ready to make a difference? The Position Senior , Clinical Informatics leads the functions in the Clinical… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …R&D, Quality , Facilities, Engineering to support their initiatives. The Director of Regulatory Affairswill supervise a team of regulatory personnel in authoring, ... Position Summary The Director of Regulatory Affairsis a strategic leader responsible...the FDA, EMEA, and other regulatory agencies to drive product approvals and maintain correspondence relating to compliance efficiently… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe Sr. Director of Technical Transfer is responsible for activities related to technology transfer from external and internal customers. This ... packaging and labeling. This position will interface with Operations, Regulatory, Quality Assurance, Finance, R&D, Project Management and Quality Control… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Establish strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential ... 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. (Bernards, NJ)
- …support; meet aggressive deadlines to ensure that FDA receives timely and quality submissions, shortening the review process and leading to successful approval of ... for regulatory filings.Strategize and plan for FDA meetings for assigned product . Liaise, negotiate and orchestrate meetings with FDA. Prepare internal meeting… more
- Merck & Co. (Rahway, NJ)
- …needs. The role is also accountable of all sourcing strategies of any product , comparator or components needed in the clinical supply chain. The role oversees ... service activities to ensure supply continuity that meets our quality , compliance, and regulatory standards.Strategic collaboration with Procurement and finance… 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
- 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
- Merck & Co. (North Wales, PA)
- …Human Health stakeholders, driving the human health digital and data transformation.The Senior Specialist will report to the Associate Director , Knowledge ... Job DescriptionAs a Senior Specialist in Knowledge Management, you will play...learning.Developing Knowledge Assets for Core Capabilities: Construct and refine high- quality knowledge products that support our essential enabling and… more
- Merck & Co. (Rahway, NJ)
- …program(s). The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie ... human health), and balancing needs of patients & ensuring stable supply of product . -Primary activities include, but are not limited to:--Interacts closely with key… more
- Tris Pharma (Monmouth Junction, NJ)
- …inquires, disseminate scientific information and report Adverse Events (AEs) and Product Quality Complaints (PQCs)Collaborates with VP/Medical Affairs to ... opening for a Head, Medical Science Liaisons (MSLs) / Director , Medical Training for our Pain division. This is...development of medical strategic and tactical plan; Collaborates with Senior Leadership and MSL team members in development of… more
- Merck & Co. (Rahway, NJ)
- …and applying rigorous scientific and ethical standards.-The Distinguished Scientist (Executive Director ) and Product Development Team (PDT) lead, Oncology Global ... areas regarding clinical issues related to oncology compounds.-The Executive Director /PDT lead may:-Manage Directors and/or Senior Directors responsible… 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 ... 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
- 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....you ready to make a difference? The Position The Senior Manager, Site Engagement is responsible for the management… more
