- Merck & Co. (Rahway, NJ)
- …(Principal Scientist)has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines. ... Certified or Eligible in Oncology (and/or Hematology)Prior specific experience in clinical research and prior publication is desirable but not… more
- Novo Nordisk Inc. (San Antonio, TX)
- …a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research...role and responsibilities Drives recruitment and retention strategies to support clinical trial sites to meet country… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in the assigned therapeutic area. Relationships Reports to the Executive Director- Clinical Research & Development. Internal relationships include working with ... Assure timely initiation of studies; act as liaison with Regulatory , project teams, and investigators. Support recruitment...area experience in diabetes, CV or Obesity required Prior clinical research or related experience (eg monitoring… more
- Merck & Co. (Rockville, MD)
- …with the company's Research Laboratories divisions and most directly with Global Regulatory Affairs and Clinical Safety (GRACS) to define and implement a ... advocacy and internal implementation.Planning and managing GRPI interactions with our Research and Development Division's colleagues, regulatory liaison staff,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …A minimum of 5 years' experience required (Pharmaceutical industry, laboratory, or clinical research experience) An intermediate to advanced proficiency in ... About the Department The Clinical , Medical and Regulatory (CMR) department...ready to make a difference? The Position Provide proactive support and technical assistance to more experienced regulatory… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical ... team to ensure adequate and appropriate resourcing for the company's internal clinical trial portfolio.Partner with Clinical Research Organization (CRO)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Affairs, as well as cross-functional stakeholders (eg, RA CMC, R&D Excellence, Clinical Operations, IT).Responsibilities Operate within and in support of the ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of… more
- Merck & Co. (North Wales, PA)
- …by leading the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed products.Represents our ... Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Develops… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has ... vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … clinical trials improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research vendors). Manages ... About the Department The Clinical , Medical and Regulatory (CMR) department...support of the planning and quality delivery of clinical trials in line with established targets and metrics… 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)
- … questions related to filings and regulatory strategy related to pathology. Support industry presence for our company in clinical pathology at national ... Head of Clinical Imaging and Pathology, Pathology Leads, and other Clinical Pathology and ImagingScientists to provide support internally and externally, as… more
- Merck & Co. (North Wales, PA)
- …member in the Risk Management Safety Teams.- Lead and provide statistical support for related drug/vaccine projects in Clinical Safety StatisticsInteract with ... Safety Physicians, Safety Scientists, Clinical Trial Physicians , Regulatory , Early/Late Development Statistics, Statistical Programming, , and other company … more
- Merck & Co. (North Wales, PA)
- …processes related to the definition, use, maintenance and sharing of clinical data standards- Support department initiatives and participate in cross-functional ... Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide...to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a difference? The Position Drives the understanding & delivery of quality clinical research (patient safety, rights & wellbeing; data reliability; scientific ... Nordisk (eg, clinical trial site staff, IRBs, clinical research vendors). Manages relationships with multiple...regulatory requirements and ICH and GCP guidelines Provides support to prepare for and follow-up on audits and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, ... team through creation of briefing materials and meeting preparation Lead and/or support global filing activities for submissions Present regulatory strategies… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical Pharmacology) studies, support Phase 2/3 studies, represent function ... of PK-PD and Pop PK-PD concepts and analysis, phase 1-4 clinical studies, literature, regulatory guidelines, and physiological/pharmacological aspects of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …team in other DSI governance process (DRF, G-PAD, GROC, GRSC etc.) Interfaces with clinical & pre- clinical groups, Regulatory CM&C and other appropriate ... the company as needed.ResponsibilitiesManages, directs, and drives the strategy for all Regulatory activities associated with the registration and support of new… more
- Merck & Co. (Rahway, NJ)
- …of quality standards and governance data management deliverables and services in support of our company's research pipeline. Manages employee performance, career ... efficiency, and productivity across the organization. Keeps abreast of project management, clinical data standards, and regulatory requirements for clinical … more
- Merck & Co. (North Wales, PA)
- …experienceDegree in life sciences, preferred.Required experience and skills: Working knowledge of clinical research regulatory requirements (eg, GCP and ... with internal and external stakeholders (eg, country operations, committees, vendors) in support of clinical study objectives. Support development of site… more
