- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , Clinical Project & Planning Management is a member of ... grid development.Must have experience managing a reporting/dashboard system.Extensive experience in clinical contracts administration , and clinical timeline… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study Team Leader for ... and immune disorders.SummaryThe incumbent will be responsible for ensuring execution of clinical studies across geographic regions, in adherence to Good Clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. SummaryThis new role is within R&D reporting into Global Clinical Operations (GCO) and the fundamental responsibility is dedicated to GCO. This ... the successful delivery of study diversity plans in adherence with Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug … more
- Insmed Incorporated (San Diego, CA)
- …lists.OverviewThe primary responsibilities are to manage all aspects of clinical operations including study planning, financial oversight, project deadlines and ... ensuring compliance with Good Clinical Practices as well as federal and local laws.ResponsibilitiesAdditional representative responsibilities will include, but not… more
- Eisai, Inc (Nutley, NJ)
- …to hear from you. As a vital member of the Americas CIO Office, the Director will also support the Global CIO Office leadership particularly in IT portfolio planning ... in computer science, information science, management information systems, or business administration or a related field or equivalent experience relevant to this… more
- Eisai, Inc (Nutley, NJ)
- …in designing, analyzing and collecting RWD using EMRs, patient charts, administrative claims datasets.Previous RWE experience in clinical /medical development, ... difference. If this is your profile, we want to hear from you. The Director is responsible for developing RWE strategies for assigned product(s) and execution of RWE… more
- Merck & Co. (North Wales, PA)
- …strategy, including field standard operating procedures (SOPs), Good Clinical Practice (GCP) guidelines, and administrative /operational ... to 50% travel required with some overnight.Role Summary The Regional Medical Scientific Director - GI Oncology is a credentialed (ie, PhD, PharmD, DNP, MD)… more
- Tris Pharma (Monmouth Junction, NJ)
- …the Pain therapeutic area to serve as Senior or Executive Medical Director . Title and salary commensurate with experience. The Executive/Senior Medical Director ... provides leadership, direction and medical expertise for company’s clinical development programs specifically focused on the treatment of Pain. The incumbent is… 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 ... of FMA throughout the US affiliate and globally if needed; responsible for administrative and management support of field-based FMA Program at Novo Nordisk Inc… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Identity key milestones at Study, Country, and Site Level to gauge clinical trial performance. Build and Maintain Metrics Catalog, Dashboards Catalog along with ... Degree bachelor's degree in computer science, Life Science, Engineering, Business Administration or related field or equivalent work experience required Experience… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you.The Associate Director , Strategic Content Development, Global Medical Affairs - Alzheimer's Disease, in the ... to the AD portfolio and continued support as a key partner to Clinical Development, Real World Evidence and Commercial Operations.The incumbent will provide disease… more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership for medical affairs strategy, planning and ... communication/publication components of overall medical operating plan. The Medical Director provides strategic development, planning, implementation and oversight of… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Medical Director will provide medical leadership for medical affairs strategy, planning and supportive ... tactics for assigned therapeutic area. Under the direction of the Senior Medical Director , this role will be responsible for working with key stakeholders to develop… more
- Merck & Co. (Rahway, NJ)
- …products across a variety of therapy areas and routes of administration including inhalation, implantation, and injection.-- This position will be responsible ... and risk management techniques to positively support and influence clinical and commercial combination product development and launches.Principal ResponsibilitiesLead… more
- Eisai, Inc (Nutley, NJ)
- …to hear from you. Job Summary: As the Americas IT Security and Compliance Director , you play a pivotal role in ensuring the organization's adherence to security, ... Business Relationships:Promotes awareness of standards related to security, regulatory, clinical , commercial, and manufacturing processes to establish a culture of… more
- Eisai, Inc (Nutley, NJ)
- …understanding of statistical methodologies and their application in the context of non- clinical studies and related projects in AD and other therapeutic areas as ... meet project deliverables and timelines within GV&A projects related to both clinical trial setting and observational studies.Serve as the lead statistician on… more
- Catalent (Philadelphia, PA)
- Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality function is to build, monitor, and sustain a robust and effective quality system ... good manufacturing practice/quality system requirements of the Food and Drug Administration , state boards of pharmacy, European, South American, Japanese, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Summary The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions in the West, in adherence ... to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …US, EU, Japan, and other global sites. These business functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory ... Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational… more
- Novo Nordisk Inc. (Minneapolis, MN)
- …This includes the execution of brand value propositions, including clinical , quality and health economics positioning and product specifications Direct/oversee ... against budget Establish, oversee implementation, and monitor adherence to administrative policies and procedures Evaluate appropriate use of resources to… more
