- Novo Nordisk Inc. (WA)
- …optimal health outcomes. Are you ready to realize your potential? The Position The Senior Director works on complex issues that require an in-depth knowledge of ... other Market Access & Public Affairs teams, Finance, Medical, Legal, Compliance , Communications and other key stakeholders locally and globally. External… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and coach cross functional team staff in areas such as quality , compliance , safety, project planning, process development, technology development.Communicate ... Position SummaryThe Sr. Director of Technical Transfer is responsible for activities...using Microsoft Office programs.Ability to design processes that ensure compliance to sound scientific Quality by Design… more
- Merck & Co. (Rahway, NJ)
- …leader to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be an experienced pharmacometrician with a ... QP2 efforts to strengthen our pharmacometrics capabilities on a continuous basis. The Senior Director will be accountable for directing a team of… 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 ... CMR employee on-boarding, cultural engagement, technical/role-specific training and GxP/Regulatory compliance across CMR functions. Position will serve as an… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …execute and deliver clinical studies/programs on time with a focus on budget, compliance and quality . Leads strong and effective communication to global and ... 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. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… 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 ... customer and the quality system integrity expected by the customer. The Quality Director is committed to relentlessly pursuing zero defect manufacturing and… more
- Merck & Co. (Millsboro, DE)
- …(USDA, DEA, DNREC, etc.) of animal facilities and program reviews is required.PurposeThis Associate Director will report to the Site Quality Head/ Director of ... Job DescriptionOur company seeks to add an Associate Director . Veterinarian Services at our Millsboro, Delaware location. This position will have overall… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …future strategies. Establish key performance indicators (KPIs) and track progress toward quality objectives. Prepare and present reports to senior leadership on ... areas centered around rare diseases and immune disorders. JOB SUMMARYThe Associate Director , GMP QA Process Excellence is accountable to collect information, analyze… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …regulatory agencies to drive product approvals and maintain correspondence relating to compliance efficiently and with utmost professionalism. The Director of ... Quality , Facilities, Engineering to support their initiatives. The Director of Regulatory Affairswill supervise a team of regulatory...position initially reports to the CEO or to another senior executive, with the potential to grow into Vice… more
- Merck & Co. (South San Francisco, CA)
- …to the Vice President of Cardiometabolic Research t he Executive Director of Cardiovascular will be responsible for overseeing and facilitating research ... at a new state-of-the-art center in South San Francisco, CA. The Executive Director will contribute to the design, prioritization, and execution of the strategic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Responsibilities:Operational Strategy:Align with the Head of Clinical Development Operations or Senior Director , Clinical Operations on plans for successful ... budget, so both can be managed appropriately.Provide oversight of the CRO to ensure compliance with Daiichi Sankyo's quality measures. Leads the creation of the… more
- Merck & Co. (Rahway, NJ)
- …tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position interacts extensively with ... and processes are developed in accordance with applicable regulatory, quality , company, and customer requirements.-This position will lead cross-functional… 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 ... 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)
- …position is responsible for implementation and oversight of the Risk Based Quality Management (RBQM) principles that support the Company's vision including elements ... to achieve a Quality by Design (QbD) and Risk-Based Quality ...activities for Daiichi Sankyo Portfolio of Studies: Serve as senior level technical RBQM SME and oversee and mentor… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Establish strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential ... 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 Associate Director , Regulatory Affairs - Advertising & Promotion will provide… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …sites to ensure all trial deliverables are met according to timelines, budget, quality standards and in compliance . Proactively track, monitor and report trial ... 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
- Tris Pharma (Monmouth Junction, NJ)
- …have an immediate opening for a Head, Medical Science Liaisons (MSLs) / Director , Medical Training for our Pain division. This is a field-based position that ... ability to travel over 50 %.Head, Medical Science Liaisons (MSLs) / Director , Medical Training, Pain therapeutic space is responsible for field leadership of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop ... difference? The Position We are looking to hire a Senior Clinical Project Manager (CPM). This is a unique...from protocol finalization through closeout. Relationships Reports to: Associate Director or Director of Clinical Operations. Essential… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the oversight, performance, and management of CRO(s) and 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and adherence to scope of ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key… more
