- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Clinical Research Manager (aCRM) - Oncology With support of other Clinical Research Manager 's ... oversight and supervision of the TA-Head or CRD.Requires understanding of local regulatory environment.Scientific and clinical research knowledge is… more
- Novo Nordisk Inc. (Atlanta, GA)
- …a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... About the Department The Clinical , Medical and Regulatory (CMR) department...and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Supervise designated personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. Develop ... About the Department The Clinical , Medical and Regulatory (CMR) department...Essential Functions Compile and submit responses to FDA communications. MANAGER , THERAPEUTIC AREA: Compile, submit and maintain applications (IND,… more
- Merck & Co. (Rahway, NJ)
- …quality standards and adverse event reporting requirements internally and externally.Our Clinical Research and Pharmacovigilance team push the boundaries of ... Clinical Trial Research Agreements (CTRA).Oversees and tracks clinical research -related payments. Payment reconciliation at study closeout. Oversees… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory ... to facilitate consistency and quality of data across key Daiichi Sankyo regulatory systems. This includes defining regulatory data standards, data quality… more
- Aequor (Thousand Oaks, CA)
- FULLY REMOTE Regulatory Writing Senior Manager ln this vital role role you will serve as the functional area lead on product teams, lead writing activities for ... Key responsibilities include: Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures,… more
- Merck & Co. (North Wales, PA)
- …Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Develops ... Services Agreement content review and approval to facilitate initial approval by regulatory agencies for conduct of clinical trials.Participates in regulatory… more
- Piper Companies (Bethesda, MD)
- …Insurance, 401k Contributions, PTO (Paid Time Off), Paid Holidays Keywords:Project manager , clinical project manager , regulatory project manager , PM, ... Piper Health & Sciences is seeking a Clinical Project Manager to support a... to support a leading consulting to support various clinical research , biotechnology, and pharmaceutical organizations. *Hybrid… more
- Tris Pharma (Monmouth Junction, NJ)
- …resolution, risk mitigation and continuous improvement through strategic partnerships with Clinical Research Organizations (CROs) and vendors across all phases ... and/or Clinical Trial Management experience in a pharmaceutical, biotechnology, clinical research or related industry in positions of increasing technical… 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...management systems and archiving systems. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in ... Experience Qualifications1 or More Years with BS. preferredExperience considered relevant includes clinical or basic research in a Pharmaceutical company, a… more
- Eisai, Inc (Nutley, NJ)
- …is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, ... want to hear from you. Job Summary The Senior Manager , Translational Science Biostatistics will be expected to work...across programs, as well as the study statistician for clinical studies. As the statistical lead for biomarker development,… more
- Eisai, Inc (Nutley, NJ)
- …to assure the procedures and agreed implementation meet respective goals and regulatory responsibilities. 20% Requirements Application of clinical medicine to ... is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in clinical trials analysis- Provide programming support to prepare regulatory requested analyses and help submission team in quick turnaround in response ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary The purpose of… more
- Eisai, Inc (NJ)
- …to obtain all applicable source materialCollaborate with cross functional teams like Clinical Research , Biostatistics, Statistical programming, Clin Ops. etc. to ... related industry OR equivalent combination of education and experienceExperience writing/reviewing clinical regulatory documents and submissions for own area of… 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. (Ames, IA)
- …and adverse reports in accordance with internal, FDA, CFIA and USDA regulatory policies.- The position will require developing trial protocols, monitoring and ... summarizing clinical and marketing support trials specific to Ruminant animal...Ruminant industry meetings where needed by communicating non-proprietary company research and representing our Company's Animal Health Division as… more
- Tris Pharma (Monmouth Junction, NJ)
- …and other strategic initiatives. This includes, but is not limited to: Research , Product Development, Clinical Development, Regulatory Affairs, CMC, ... in our Monmouth Junction, NJ facility for a Senior Manager , Business Development.The primary role of the Senior ...provide input on deal terms and creation of relevant clinical , regulatory , and commercial scenarios Prepare clear… more
- Eisai, Inc (Nutley, NJ)
- …is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, ... difference. If this is your profile, we want to hear from you.Senior Manager , US Alzheimer's Strategy and Lifecycle Planning Marketing will assist with the… 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
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