- Merck & Co. (Rahway, NJ)
- …(Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed Oncology medicines. ... about twenty (20) percent of the time to manage future or ongoing clinical research projects.Education:- MD or MD/Ph.D. or Ph.DRequired:Must have experience in… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Clinical Research Manager (aCRM) - Oncology With support of other Clinical Research Manager's (CRMs) ... 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 ... 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
- 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. (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. (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
- 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 ... and maintain applications (IND, NDA, Biologics, Devices) to government agencies in support of research and marketed products Create and maintain product/project… more
- Merck & Co. (Rahway, NJ)
- …imaging tools, and data analy sis. You would also contribute towards regulatory submissions to enable clinical trials. Your main responsibilities include: ... Job DescriptionThe Small Molecule Analytical Research and Development (SMAR&D) group has an exciting...of release, characterization, and stability assays for testing of clinical trial material and in support of… 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
- 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
- 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)
- …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
- 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
- Tris Pharma (Monmouth Junction, NJ)
- …during creation, execution and analysis of grant funded research (preclinical and clinical ). She/he may also be required support other clinical ... aspects of the development, oversight and execution of phase I to IV clinical research trials. Collaborating closely with Physicians, Clinical Leaders… more
- Eisai, Inc (NJ)
- …oversee and lead and support activities related to the outsourcing of clinical services to Clinical Research Organizations (CROs) and functional service ... 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
- Merck & Co. (North Wales, PA)
- …and medical teams to ensure that promotional practices are consistent with regulatory guidelines, our company's policies, and support business objectives.Serve ... and policies and business objectives.Actively- participate in labeling and global regulatory team meetings to ensure support for anticipated promotional… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, companion ... oncology pharmaceutical products. Provides innovative approaches to resolve complex regulatory issues and increase speed to patients.ResponsibilitiesCDx development: Provide… 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
- Catalent (St. Petersburg, FL)
- …and new material qualifications. AR&D interacts with clients to provide not only research and testing of products, but also support CMC development activities ... Associate Scientist II, Analytical Research & Development Position Summary Catalent is a...in support of client regulatory filings. Activities are performed in accordance with specifications,… more
