- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position Manage and oversee all assigned projects/products/processes. Assist the Director/ Associate Director in assuring Novo Nordisk compliance with ... agencies. Supervise designated personnel. Relationships Report to the Director/ Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory … more
- Merck & Co. (Rahway, NJ)
- …to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on ... or Associate Vice President, Therapeutic Area Lead.Develops worldwide product regulatory strategy to optimize label and obtain shortest time to approval by… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …based on potential impact on product quality, patient safety, and regulatory compliance . Address recurring deviations and health authorities' observations ... in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of… more
- Aequor (Thousand Oaks, CA)
- …support of product development? Knowledge of protein and small molecule quality, compliance and regulatory requirements? Knowledge of analytical techniques used ... executive leadership, International Quality, Quality Control, Contract Manufacturing Quality, Regulatory , Process Development, Quality Assurance, and other functional areas… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Associate Director, Clinical Data Standards, is responsible for the development, ... and enforcement of data standards, demonstrated knowledge of industry standards related regulatory requirements (CDISC), FDA & ICH, PMDA, EU & ICH, CRP and… 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
- Aequor (Athens, GA)
- …functions in the Quality Control Department: Sample Life Cycle Management in compliance with procedures and regulatory requirements. Responsible as an approved ... ensure testing, release and support functions are consistent and within regulatory requirements. Functional knowledge of computer systems such as laboratory… more
- Insmed Incorporated (San Diego, CA)
- …lists.OverviewReporting to the Executive Director of Program Management, the Associate Director, Program Management supports the cross-functional drug development ... in accordance with the program strategy. In addition, the Associate Director of PM may be asked to lead...& objectives by ensuring program work is conducted in compliance with PMO processes and Company policies and leading… more
- Insmed Incorporated (Bridgewater, NJ)
- …to foster positive working relationships and drive team success.Work closely with legal, regulatory and compliance teams to ensure compliance with all ... and experienced individual to join our team as the Associate Director of Patient Marketing, focusing on email and...Marketing, focusing on email and performance marketing strategies. The Associate Director, Patient Marketing will be a key member… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …accuracy and consistency of the coded data, and adherence to regulatory authorities' requirements.Ensure compliance with the protocol, external/internal ... delivery of medical coding for clinical trials, clinical development, and regulatory submissions. Develops and proposes strategies for medical coding and coding… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the CMR training strategy Ensuring CMR employees receive training on regulatory compliance , quality standards, GxP requirements and industry-specific guidelines ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Aequor (Thousand Oaks, CA)
- …analysis for effective decision making in NA-TO Hub Manage and oversee Compliance related activities Develop strategic and tactical processes that increase the ... or Business experience preferably in the biotechnology or pharmaceutical industry OR Associate 's degree and 6 years of Life Science or Business experience preferably… more
- Insmed Incorporated (Bridgewater, NJ)
- …brand's HCP Agency of Record.Work closely with cross-functional partners including Legal, Regulatory , Compliance , and Medical Affairs, to align and compliantly ... Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director, HCP Marketing, Branded Strategy & Execution will be a key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical ... against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile… more
- Novo Nordisk Inc. (WA)
- …research (patient safety, rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance ) for monitoring and site management ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Associate Director, Global Clinical Operations (GCO) Procedural Ownership and Life ... guidelines, and policies, and meet applicable ICH and GCP standards. The Associate Director will also be responsible for the creation, management, and documentation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key ... Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …providing direction and execute oversight of vendor delivery, to ensure compliance with the protocol, external/internal standards, applicable regulatory ... awareness of best practices for reproducible data science, global regulatory requirements, internal guidelines and Standard Operating Procedures (SOPs)- Ensure… more
- Aequor (West Greenwich, RI)
- …PHD. Ideally looking for candidates with at least 2 years of an associate degree combined with 2 years of General lab experience/lab background, GDP/GMP experience ... as necessary. 6. Perform general laboratory housekeeping activities. 7. Maintain training compliance and proficiency. 8. At all times, comply with safety guidelines,… more
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