- Merck & Co. (Rahway, NJ)
- Job Description Job Description: The Rahway based Senior Specialist, Global Development Quality Operations - API, is responsible for independent review and ... compliance activities such as site readiness, audits, inspections, and CAPAs. Support quality risk management activities as facilitator, project lead and/or … more
- Merck & Co. (South San Francisco, CA)
- …company's Research Laboratories in South San Francisco is seeking a Senior Scientist with experience in cell-based model and assay development, mechanistic ... pharmacology, and lead discovery support to join our Quantitative Biosciences (Pharmacology)...and implement best experimental practices to improve assay operation, quality , and overall productivity.Identify, evaluate, and champion new enabling… 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 ... matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing… more
- Merck & Co. (South San Francisco, CA)
- …as mechanistic experimentation to advance drug discovery from target concept through lead optimization. The candidate will also work closely with therapeutic area ... immuno-metabolic, and cardiovascular diseases to enable a robust drug discovery pipelineDrive hit/ lead finding and lead optimization plans in collaboration with… more
- Insmed Incorporated (San Diego, CA)
- …for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.QualificationsThe Senior Scientist will be a part of a multidisciplinary team of ... Support all CMC characterization LC/MS related method development and product quality attribute characterization is authored into IND(a) and BLA submissions for… more
- 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 the ... enables broader PA Team and NNI business to leverage these positions. They lead and manage individual contributors in the Policy team, actively participate with the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …& Leadership:Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key… more
- Merck & Co. (Rahway, NJ)
- …RaDS IT Research Infrastructure Product Line (RIPL) engineering team is seeking a Senior Specialist - Research Automation OT Infrastructure. This position will be a ... and Plant) within RIPL. -As Sr. OT Infrastructure Specialist, you will lead the definition and implementation of high-level requirements, principles and models that… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …across organizational lines to ensure delivery of projects within cost, time and quality requirements. As a leader in GPM&L this position is also responsible for ... organizational efficiency and decision making.Responsibilities: Project ResponsibilitiesIndependently manage or lead strategy development for high complexity drug development projects/programs.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Academia. L ine management responsibility of Director/Associate Director Global Safety Lead , Senior Global Safety Scientist(s)/Global Safety Scientist(s) within ... us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop new… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Information team. The Senior Manager will also serve as the onboarding lead for the Medical Information team. Relationships Position reports to the head of ... 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 of Medical Information Operations Excellence supports development,… more
- Merck & Co. (Rahway, NJ)
- …offers an opportunity for the Pharmacometrics leader to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to ... efforts to strengthen our pharmacometrics capabilities on a continuous basis. The Senior Director will be accountable for directing a team of pharmacometricians with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the product owner for pertinent solutions and as the Compliance and Legal lead to uphold integrity across PSS programs. This role also involves establishing ... tools, and processes to achieve and maintain operational excellence across PSS. Lead and manage projects within Patient Support Solutions to drive operational… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …packaging and labeling. This position will interface with Operations, Regulatory, Quality Assurance, Finance, R&D, Project Management and Quality Control ... to complete the technology transfer for customers. This position will lead , mentor and grow the Technical Service Department.Job ResponsibilitiesFunction as the… more
- Merck & Co. (Rahway, NJ)
- …medical device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- ... products and processes are developed in accordance with applicable regulatory, quality , company, and customer requirements.-This position will lead … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Rare Disease products. Relationships The position reports directly to a Lead in Strategic Pricing and Contracting and provides analytical support to their ... and financial analysis Assists with the development of presentations for senior management regarding contracting and pricing strategies Supports business and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Administrative Assistant to provide comprehensive support to leaders and members of GMP Quality Assurance team and will serve as the primary point of contact for ... decisions and overcomes challenges using experience and resourcefulness and may lead lower levels in prioritizing and distributing workResponsibilities for the role… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and new product commercialization assets (3 years prior to launch). They will lead the development and implementation of brand plans, development of capabilities to ... functions that drive success. They will be empowered to make strategic decisions and lead the development and roll-out of tactics that pull through the strategy and… more
- Genmab (Plainsboro, NJ)
- …essential to fulfilling our purpose.The Role & DepartmentGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join our Global Clinical Drug Supply ... Operations team.As Senior Clinical Drug Supply Manager you will play a...a pivotal role in ensuring the timely delivery of high- quality clinical trial supplies for both early and late-stage… more
- Aequor (Thousand Oaks, CA)
- …(SCPM) will translate product variation strategy as determined by the Variation Lead for reportable changes for Global Distribution control. May also translate ... product launch/variation strategy as determined by the Regional Operations Lead to an executable implementation plan for launch/variation changes for Customer Facing… more
