- Merck & Co. (Rahway, NJ)
- …Associate Principal Scientist position available at its Kenilworth, New Jersey research facility.- The Associate Principal Scientist is a laboratory-based ... Job DescriptionOur Research Scientists are our Inventors. We identify and...of release, characterization, and stability assays for testing of clinical trial material and in support of product and… 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 at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Merck & Co. (North Wales, PA)
- … Clinical Safety StatisticsInteract with Safety Physicians, Safety Scientists, Clinical Trial Physicians , Regulatory , Early/Late Development Statistics, ... eg SAS and/or R.-Good project management skills. --Good understanding of worldwide regulatory requirements and clinical trial expertise .Strong oral and written… 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)
- …the Director/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and approval of all US ... promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to...promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates… more
- Catalent (St. Petersburg, FL)
- Associate Scientist II, Analytical Research & Development Position Summary Catalent is a global, high-growth, public company, and a leading partner for the ... services to solve difficult development and manufacturing challenges. The Analytical Research and Development (AR&D) laboratory that supports evaluation and testing… 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 ... position drives scientific planning, strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead, you will collaborate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Oversees typically… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary 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… more
- Insmed Incorporated (Bridgewater, NJ)
- …purchase orders, payment tracking and process for external parties.Strong knowledge of clinical research process, including working knowledge of all functional ... experience in a Clinical Operations Experience considered relevant includes clinical and/or basic research in a bio/pharmaceutical company, Academic … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical ... and our company's guidelines and SOPs.Required Experience:5+ years of work experience in pre- clinical and/or clinical research to include minimum 2 years'… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …payment schedules) Advanced knowledge of regulatory and compliance requirements for clinical research , ICH GCP Principles and the application of those ... 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
- Merck & Co. (North Wales, PA)
- …datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing ... of statistical databases that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.The position is… 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 ... or More Years with Bachelor of Science required- Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ResponsibilitiesProvide outstanding leadership skills based on a sound knowledge of clinical research standards and GCP.Develop operational strategies for ... program. This position will require line management responsibility of Directors, Associate Directors, Clinical Study Managers, who are primarily responsibility… more
- Merck & Co. (North Wales, PA)
- …includes integrating strategic and tactical input from diverse disciplines (eg, clinical , regulatory , market access, manufacturing, CMC, commercial, and other ... Job DescriptionGlobal Project and Alliance Management (GPAM) sits in the Research & Division organization of our company. GPAM comprises several distinct groups,… more
- Merck & Co. (Boston, MA)
- …Medicine (TMed) Immunology strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.-The AVP provides strategic ... Job DescriptionThe Associate Vice President (AVP)/Therapeutic Area Head, Immunology Translational...network of key cross-functional partners both within TMed, Discovery Research , and Global Clinical Development.-The candidate will… more
- Merck & Co. (North Wales, PA)
- …resources, professional development, and performance management Core Skills Strong knowledge of clinical research regulatory requirements (eg, GCP and ... the operational planning and execution of one or more clinical trials. In this position, you will have the...collaboration with external stakeholders, such as customer-facing commercial, or research -based roles, will be expected to comply not only… more
- Merck & Co. (North Wales, PA)
- …datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing ... of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation. The position… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary The Technology ... gaps at the manufacturing sites.- Conduct scouting activities and recommend CDMOs for clinical and launch site selection from Tech Mgmt. (mAb, Drug Substance, Drug… more
