- 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)
- 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
- Merck & Co. (North Wales, PA)
- …mentorship to other clinical scientists.Core Skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage ... the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position,...you will have the opportunity to demonstrate your leadership, technical skills, and scientific acumen as part of a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Company Core Data Sheet (CCDS), Risk Management Plan(s) (RMPs) - Contributes to regulatory authority requests or communication for assigned clinical studies - ... CTD submissions/Others - May support Common Technical Document (CTD) submissions by collaborating with ... Technical Document (CTD) submissions by collaborating with Clinical Safety Scientist Lead, Clinical Safety Physician(s),… more
- Merck & Co. (Rahway, NJ)
- …efficiency, and productivity across the organization. Keeps abreast of project management, clinical data standards, and regulatory requirements for clinical ... Job DescriptionPosition Description: Manager, Operations and Reference Data Management, Global Clinical Data Standards Working closely with the Global Clinical … more
- Novo Nordisk Inc. (San Antonio, TX)
- 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)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... other areas within NACD, CMR and global partners Demonstrates technical proficiency within responsible areas, stays up to date...of more recent years working as an employee in clinical , medical and/or regulatory in the pharmaceutical,… more
- Merck & Co. (North Wales, PA)
- …the clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study ... key strategic engagements. This includes the ability to:Apply strong knowledge of clinical research regulatory requirements (eg, GCP and ICH)Manage multiple… more
- Merck & Co. (North Wales, PA)
- …in life sciences, preferred.Required experience and skills: Working knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to ... the scientific planning and execution of one or more clinical trials in the lung cancer program. Assists the...you will have the opportunity to develop your leadership, technical skills, and scientific acumen as part of a… 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 ... you ready to make a difference? The Position Provide proactive support and technical assistance to more experienced regulatory personnel. Identify issues and… more
- BioAgilytix (Durham, NC)
- …complete and scientifically sound product submissionsPrepare pre-market submission reports / technical files / clinical trial applications per the requirements ... The Regulatory Affairs Manager is responsible for coordinating the regulatory activities for projects including new products and life cycle management. This… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and reporting capabilities, incl. creating reports and dashboards of key regulatory data/metrics from across systems, leveraging technical integrations and ... as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory … more
- Catalent (Manassas, VA)
- …8 + years within the Pharmaceutical or related industry ; 5+ years in regulatory role 5+ years of leadership Strong technical competencies and communication ... Associate Director, Regulatory Affairs Position Summary: Catalent is a global,...sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- 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 organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …clinical trials is required Demonstrates technical expertise within Clinical Development, Medical Affairs, and Regulatory Affairs (CMR), staying ... About the Department The Clinical Development, Medical and Regulatory (CMR)...SOPs, KPIs, internal processes; Track and measure specific CMR technical metrics. Work to accelerate innovation across CMR functions… more
- Merck & Co. (Ames, IA)
- …with primary responsibilities in (IA, SD, MN) and is responsible for providing technical support to Sales and Marketing for our Company's Animal Health products ... with a primary focus on the Dairy Industry. Responsibilities include providing technical support for Ruminant products and programs, including response to product… more
- Merck & Co. (North Wales, PA)
- …Writer is responsible for developing medical writing deliverables that support the clinical regulatory writing portfolio. With minimal oversight, the Senior ... Medical Writer:Demonstrates independence in preparing clinical regulatory documents (eg, protocols, clinical study reports, investigator's brochures, … more
- Merck & Co. (Rahway, NJ)
- …support for related drug/vaccine projects in Late Development Statistics.Interacts with Clinical , Regulatory , Statistical Programming, Data Management, and other ... that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs.Independently identifies and anticipates technical or… more
- Merck & Co. (Rahway, NJ)
- …related drug/vaccine projects in Late Development Statistics.Lead the interaction with Clinical , Regulatory , Statistical Programming, Data Management, and other ... that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs.Independently identifies and anticipates technical or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diverse external providers for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. The position will perform ... with the protocol, Policies, SOPs, external/internal standards, pertinent Good Clinical Practices (GCPs), applicable regulatory requirements, and other… more
