- Eisai, Inc (NJ)
- …this is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities related to ... Salary Transparency Language:The base salary range for the Associate Director , Clinical Outsourcing is from :157,200-206,300Under current guidelines,… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. JOB SUMMARYThe Director , Clinical Project Management will manage assigned project (s), including program's ... with agreed to development plans and corporate objectives. Advanced understanding of clinical research and the clinical drug development process Advanced… 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
- 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
- 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 ... time throughout the annual performance cycle. Relationships Reports to Executive Director or Vice President Medical Affairs. Has direct supervisory responsibility… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics ... communication/publication components of overall medical operating plan.The Sr Medical Director provides strategic development, planning, implementation, and oversight of… more
- Merck & Co. (Rahway, NJ)
- …enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training ... pilot plant. The Facility Lead position reports to the Director of Operations/Head of SSO Pilot Plant and the...members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of the processes, and… 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
- 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
- Eisai, Inc (Exton, PA)
- …through phase 3, knowledge of the regulatory requirements at each stage of clinical development is essential.This position will have a direct impact on the success ... Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment… more
- Eisai, Inc (Nutley, NJ)
- …describe complex disease processes to understand and evaluate the implications of clinical trials and real-world data; demonstrate the value of interventions beyond ... Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment… more
- Tris Pharma (Monmouth Junction, NJ)
- …success.We have an immediate opening in our Monmouth Junction, NJ facility for a Director , Drug Safety. The Director , Drug Safety is responsible for planning, ... management planning. The incumbent works cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs, Manufacturing, Quality, etc. to identify,… 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)
- …disorders. Summary The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence to Good ... Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food...(GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …accredited college or university)- Bachelor's Degree required- Master's Degree Business Administration or Life Sciences preferred Experience- 7 or More Years ... Outsourcing, health sciences or related field ( clinical trials) required- 7 or More Years Deep experience in pharma procurement & category management required- CRO… more
- Eisai, Inc (NJ)
- …Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle ... obtain all applicable source materialCollaborate with cross functional teams like Clinical Research, Biostatistics, Statistical programming, Clin Ops. etc. to ensure… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and resource strategies for a VP Function of the Clinical Development, Medical & Regulatory Affairs (CMR) Business Unit....of best practices. Relationships The Manager, reports to the Director , CMR Business Planning & Strategy. The incumbent works… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …be part of the Compliance organization and will report directly to the Director , Compliance Training, Policy & Communications. This position will be responsible for ... organization and will work regularly with all business areas (Sales, Marketing, Clinical , TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT,… more
