- Direct Counsel (Washington, DC)
- …York, or Chicago (hybrid work schedule available) Direct Counsel is seeking a Junior Healthcare Regulatory Associate to join a nationally recognized Am Law 100 ... Qualifications: JD from an accredited law school 2-3 years of relevant healthcare regulatory experience, ideally from an Am Law 100 firm Licensed to practice… more
- Merck & Co. (Rahway, NJ)
- …experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement experience ... System Associate for the Labeling Operations area within the GRACS Regulatory Innovation & Information Management organization.Primary area of responsibilities will… more
- Merck & Co. (Upper Gwynedd, PA)
- …Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance ... assigned development products. -Primary responsibilities include, but are not limited to: Regulatory Responsibilities: Serve as a CMC Product Lead for assigned… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:The Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory ... strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.Contributing to the continuous improvement of the… more
- Eisai, Inc (Nutley, NJ)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... to hear from you. Job Summary The Executive Director, Regulatory Affairs will provide leadership and direction for the...Affairs will provide leadership and direction for the global regulatory aspects of Eisai's products under development and post… more
- Merck & Co. (Durham, NC)
- …and techniques as they relate to laboratory testing start-up, regulatory requirements for new assay development/validation, project timelines and budgeting.Build ... team goalsUnderstand and apply cGMP/GLP, Compendial, and other applicable regulatory requirements toward analytical testingCapability to function effectively within… more
- Merck & Co. (Rahway, NJ)
- …momentum, and an inspiring mission to achieve new milestones in global healthcare . The Biologics and Biopharmaceutics team is responsible for the research and ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Merck & Co. (Rahway, NJ)
- …teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing ... clinical development, including study design, initiation, execution,- monitoring, analysis, regulatory reporting, publication, and presentation at national and international… more
- Merck & Co. (Rahway, NJ)
- …in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination products.The incumbent must be able to lead ... full integration of the device development activities with the clinical, regulatory , formulation, commercial and other key company functions.Lead the Device… more
- Merck & Co. (Rahway, NJ)
- …from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position will interact ... ensure they are developed and manufactured in accordance with regulatory , company, and customer requirements.- -Principal ResponsibilitiesLead/contribute to device… more
- Merck & Co. (North Wales, PA)
- …design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/ ... designing and analyzing clinical trials in support of worldwide regulatory submissions.This position involves interaction with Medical, Data Coordination,… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... and quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development projects.… more
- Merck & Co. (Rahway, NJ)
- …with the company's business goals, and quality and regulatory compliance.-Essential Duties and Responsibilities:Strategic Leadership and Project Management:Provide ... with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality.Provide Voice of Manufacturing input to early development teams… more
- GE HealthCare (Madison, WI)
- …of contact for internal teams, senior leadership, and external partners (eg, healthcare providers, regulatory bodies), providing regular updates on program ... global regulatory requirements (eg, FDA, CE Mark) and GE Healthcare 's quality standards. Continuous Improvement : Drive process improvements, leveraging lean… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the most diverse and collaborative groups within the organization. From healthcare provider interactions and developing and implementing regulatory strategies ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the most diverse and collaborative groups within the organization. From healthcare provider interactions and developing and implementing regulatory strategies ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... under supervision in Late Development Statistics. --Interacts with Clinical, Regulatory , Statistical Programming, Data Management and other company Research… more
- Merck & Co. (Rahway, NJ)
- …of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be responsible ... closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects;… more
- Merck & Co. (Durham, NC)
- …The Durham EHS Lead influences site leadership ensuring compliance with regulatory requirements, corporate standards, policies, and procedures related to EHS as ... of required reports to site, divisional and/or corporate management and regulatory agencies.Manage budgetary & capital needs to support EHS initiatives, projects… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the most diverse and collaborative groups within the organization. From healthcare provider interactions and developing and implementing regulatory strategies ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...for all our job applicants. We're not your typical healthcare company. In a modern world of quick fixes,… more
