- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary This position works with the Director, Clinical Study Startup to establish the strategy driving global Clinical Study ... provides input on electronic data capture (EDC) Safety report outputs, reviews clinical study and post-marketing protocols and the Clinical Study Oversight Plan,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders.Summary Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the ... Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development, ... review. Acts as main statistical contact for the assigned studies and projects. Provides guidance to study ...closely with data manager to ensure high quality data.- Drug Development Strategy: Provides input to multiple aspects of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure high quality coding deliverables are on time to support drug development processes and global submissions. This position also partners with internal ... programs concurrently. This position will manage coding resources of assigned studies . This position requires a strong working knowledge of medical terminology… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …across the internal and external network. Manages Phase 1-3 studies (depending on assignment) with demonstrated decision-making capabilitiesProvides medical and ... scientific expertise to cross-functional DSI colleagues.Responsibilities: Medical Monitoring:For studies in which Medical Monitoring activities are conducted in-house:Provides… more
- Merck & Co. (Rahway, NJ)
- …scientific community. Scientific exchange does not include promotional claims about any drug , vaccine or biologic product. RMSDs provide to Scientific Leaders (SLs) ... Trials to enhance the understanding of the scientific foundations and goals of the study , support patient enrollment and retention efforts for a given study or… more
- Insmed Incorporated (San Diego, CA)
- …and scientific support to clinical development and operations, regulatory, medical affairs, drug safety, and quality assurance teams, as well as overall program ... in cross functional teams to develop and implement clinical studies within clinical program(s). Responsibilities include but are not limited… more
- Merck & Co. (North Wales, PA)
- …approved, in-development, and active Company-sponsored trials and/or investigator-sponsored research studies . The Regional Medical Scientific Director serves as a ... of interest-*Scientific exchange does not include promotional claims about any drug , vaccine, or biologic product.-- Regional Medical Scientific Director have no… more
- Merck & Co. (Rahway, NJ)
- … to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in internal and ... will manage the entire cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. Specifically,… more
- Merck & Co. (Rahway, NJ)
- … to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; and participating in internal ... Director will manage the entire cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. --… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …to join our in vivo pharmacology team responsible for conducting in vivo studies with mice and NHP to support pipeline development. This position will report ... extensive knowledge and hands-on experience in conducting in vivo Pharmacology studies , especially in conducting cell-therapy based studies . The candidate… more
- Merck & Co. (Rahway, NJ)
- … to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in internal and ... determination of appropriate disease indications to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and… more
- Aequor (Thousand Oaks, CA)
- …include: Participate in the planning, design, execution, and documentation of studies related to drug product formulation and process development ... currently seeking an external worker to join our Pivotal Drug Product Technologies Group as Process Development Senior Associate...in the automation team to coordinate, organize and execute studies Participate in team meetings by sharing study… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with therapeutically aligned global counterparts in Medical Science, Patient Focused Drug Development, Data Science and Global Evidence and Pricing Access. In ... patient focused research through development of rigorous qualitative and quantitative study research proposals, protocols, analysis plans and reports Serves as… more
- Merck & Co. (Rahway, NJ)
- …in the SAP system to establish a consolidated , visible forecast for all study product needs (Bulk Drug Product and Clinical Finished Goods). Responsible for ... for establishing the timelines for clinical supply needs per study and providing the signal for sourcing, manufacturing, packaging,...d evelopment and User Acceptance Testing (UAT) for assigned studies . Mentors new team members and supports staff… more
- Merck & Co. (North Wales, PA)
- …include:Collaborating cross-functionally in the development of Protocol and related study materials (eg, ICF documents / amendments); Partners with the ... Study Manager on study deliverables.Ensuring CRF design...presentation skillsExperienceBachelor's degree + 5 years of pharmaceutical, clinical drug development, project management, and/or medical field experienceMaster's +… more
- Aequor (South San Francisco, CA)
- …support the overall safety assessment for our Client therapeutics spanning drug discovery through clinical development and marketing. The group provides ... platforms / approaches to support toxicity testing for our drug discovery programs. This is an ideal position for...reports as appropriate. Adhering to departmental SOPs to ensure study integrity and quality. Conducting experiments with a high… more
- Merck & Co. (Rahway, NJ)
- …and active pharmaceutical ingredients (API), streamlining structure-activity relationship studies . The position is also accountable for successful transition ... chemistry, or related pharmaceutical science is required.Required:Five or more years of drug discovery or drug development experience and demonstrated ability in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical regulatory documents include, but are not limited to, clinical study reports, investigator brochures, regulatory briefing documents, and clinical and ... to strategic planning and provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced… more
- Aequor (Thousand Oaks, CA)
- …reports generated by the scientific staff in TS&BA and the Pharmacokinetic and Drug Metabolism (PKDM) groups. This role will provide oversight of nonclinical report ... staff to assure data integrity of regulatory documents against study reports, study reports (nonGLP and GLP)...candidate would benefit from prior experience in a nonclinical drug safety or pharmacokinetic lab environment and requires the… more
