- Eisai, Inc (Nutley, NJ)
- …and Business Relationships:Promotes awareness of standards related to security, regulatory , clinical , commercial, and manufacturing processes to establish ... 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, … more
- Eisai, Inc (Nutley, NJ)
- …in helping to shape and drive oncology pipeline advancement by coordinating with Clinical Development and Clinical Operations . Essential Functions Work with ... of the pharmaceutical marketplaceFDA regulations/ICH guidelines regarding conduct of clinical studies in relevant therapeutic area.Knowledge of regulatory … more
- Merck & Co. (Rahway, NJ)
- …monitoring, analysis, regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre- clinical ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has...closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical… more
- Merck & Co. (Rahway, NJ)
- …and solutions to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory ... Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Primary… 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 ... of 7 years of relevant experience. required Experience Qualifications Experience in clinical operations methods and processes in industry setting. required… more
- Merck & Co. (Rahway, NJ)
- …role of Associate Director . The team is part of the Global Clinical Development organization and has oversight over drug development aspects related to ... expectations for small molecules and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs),… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head ... study management and delivery for all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for ensuring the clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or several programs.Partner and collaborate with RD leaders in Clinical Operations , Biostatistics and Data Management, Regulatory Affairs, and other RD ... Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical ... Clinical Development, Asset & Portfolio Management, Global Clinical Operations , BDM and DLT membersHe/she will… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... decision-making at our company, this position offers an opportunity for the Director to drive pipeline impact and mentor/coach a talented group of… more
- Merck & Co. (Rahway, NJ)
- …innovative medicines that help people across the globe. Competitive Intelligence Director Individual will be responsible for providing Competitive Intelligence (CI) ... area capabilities. Partnering with key stakeholders, individual will benchmark competitor clinical data, business models and capabilities to develop insights and… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... at our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate Director … more
- Merck & Co. (Rahway, NJ)
- …on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the BDC Pilot ... to onboard new technologies, facilitate tech transfer, and ensure efficient operations . Communication, organization, and solid controls experience will be critical… more
- Merck & Co. (Rahway, NJ)
- …cancer patients globally.We are currently seeking an Oncology Competitive Intelligence Director specializing in Women's Cancers. This role is responsible for ... insights, benchmarking, and recommendations for commercialization strategies, portfolio prioritization, clinical development/research strategies, and Business Development initiatives.Partnering with discovery… more
- Merck & Co. (Rahway, NJ)
- …drug and vaccine programs.Interact with cross functional scientists including, Statistics, Clinical , Regulatory , QP2, CSRM, Data Management and Statistical ... Programming to plan for the statistical analysis and reporting of clinical drug and vaccine projects.Set direction for the analysis and reporting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The global head of regulated bioanalysis will also form strategic internal (DMPRL, Clinical Operations , Data Management, Scientific Operations etc) and ... position has extensive knowledge of regulated BA, DMPK, biological sciences, clinical pharmacology, BA strategic planning, regulatory guidance, and in-licensing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with… more
- Eisai, Inc (Nutley, NJ)
- …exceed sales objectives. This will be accomplished by conveying complex clinical information to customers and key stakeholders regarding FDA-approved indications of ... and Company regulations and guidelines; apply these standards across all business operations to ensure compliance with our company and industry policies (ie… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 collaboration with Global Regulatory Leads (GRLs). This position may serve as an...3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …MSA discussions of external vendors by engaging with key cross-functional stakeholders ( Clinical Operations , Clinical Biomarkers, Precision Medicine, etc.) ... diverse external providers for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. This position may propose… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with other functional areas such as biostatistics, data management, clinical operations , pharmacovigilance, regulatory affairs, etcQualifications: ... sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this workPossesses… more
