- Merck & Co. (Rahway, NJ)
- … risk management activities to ensure the delivery of high- quality products and efficient manufacturing processes. The role requires extensive collaboration ... within the Device Development team and with external partners.Understand and apply regulatory and compliance requirements relevant to device risk management… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential Functions… more
- Genmab (Plainsboro, NJ)
- …supplemental BLA submissions, tracking of progress of PMRs and PMCs, etc. Evaluate regulatory risk and recommend mitigation strategies to global regulatory ... authentic is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: This role is responsible for providing regulatory strategic and tactical leadership, and alignment to ways of working on ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting to the Director of Medical Device and Combination Product Quality Assurance, the Associate Director Quality Engineering & ... of a combination product.Review and approve Design Control and Device Risk Management documentation for regulatory filings, clinical supply, development,… 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 ... quality system integrity expected by the customer. The Quality Director is committed to relentlessly pursuing...part 820, 21 CFR part 4, and all associated regulatory requirements.Drive risk management in design, validation,… more
- Fidelity Investments (Boston, MA)
- …risks to assist management in improving their controls and processes.The PositionThe Director , Asset Management Risk , Cryptocurrencies and Digital Assets will ... Job Description:The TeamAsset Management Risk provides direction to management and business units...targeted data analysis to identify risks for management.Perform ad-hoc quality control reviews for presentations and reports built by… more
- Merck & Co. (Rahway, NJ)
- …multidisciplinary team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound ... of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …objectives. Implement and use efficient project management tools, eg, Communication Plan and Risk Based Quality Monitoring documents, such as Risk Assessment ... merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both...The Position We are looking to hire an Associate Director of Clinical Operations. This is a unique opportunity… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …external (especially regulatory , but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned ... as well as other research areas centered around rare diseases and immune disorders.SummaryThe Director , Clinical Safety, will be a product safety lead or part of a… more
- Merck & Co. (Rahway, NJ)
- …manufacturing and 10 years overall within biopharmaceuticals.Planning and facilitating high risk and highly complex Quality -related process reviews and/or ... compliance gaps and proactively leading the resolution of issues affecting quality and efficiency.Interpreting complex regulatory requirements for various… more
- Merck & Co. (Rahway, NJ)
- …CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing is essential.The successful ... and retaining diverse talent.Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to ... reconciliation reports, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements. Oversees the execution… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 ... and external stakeholders. Relationships This position will report to Executive Director - Safety Surveillance, US East Coast Development Hub. Key internal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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 ... internal and external stakeholders. Relationships This position will report to Senior Director or Executive Director Safety Surveillance, US East Coast… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …make a difference? The Position Reporting to the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Merck & Co. (Rahway, NJ)
- …will ensure products and processes are developed in accordance with applicable regulatory , quality , company, and customer requirements.-This position will lead ... tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position interacts extensively with… more
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.The RoleGenmab is searching for an experienced Director , Global Clinical Drug Supply to be part of Global Clinical Drug Supply ... skills and knowledge on process management & improvement, strategic & risk management planning, change management and stakeholder management. Leading and supporting… 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 ... internal and external stakeholders. Relationships This position will report to Executive Director of Global Safety US East Coast Development Hub. Key internal… more
