- Merck & Co. (North Wales, PA)
- …to lead the coordination and execution of major change projects across Global Clinical Trial Operations. The role will also assist with Program Management Office ... and adapt plans based on evolving needs to ensure on-time, high- quality delivery in accordance with the stated project goals.Ensure cross-initiative alignment… more
- Merck & Co. (North Wales, PA)
- … standards.- Preferred Capabilities: Understanding of pharmacovigilance, medical affairs, clinical operations and product quality complaints processes and ... Signaling, Analytics & Reporting. Reporting into Product Line Lead Patient Safety, Quality & Compliance, this position will be responsible for managing the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population… more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities ... development.#LI-TS1Eisai Salary Transparency Language:The base salary range for the Associate Director , Clinical Outsourcing is from :157,200-206,300Under… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.SummaryThe Senior Director of Clinical Operations will manage clinical operations ... program. This position will require line management responsibility of Directors, Associate Directors, Clinical Study Managers, who are primarily responsibility… 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 ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submission requirement, review study submission data package and ensure its quality and integrity.- Provide hands-on statistical programming support to regulatory ... to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes Processes and Best Practices: Reinforces labeling best… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... of statistical activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides input to multiple aspects of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables on time and within budget to support drug development ... and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position… more
- Merck & Co. (Rahway, NJ)
- …new milestones in global healthcare. Our company's Pharmaceutical Sciences & Clinical Supplies organization translates molecules to medicines, working from the ... a range of modalities including small molecules and peptides.- Within OFS, the Director will influence the strategy, lead activities, and develop a team whose roles… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... of statistical activities; collaborates closely with data manager to ensure high quality data.Drug Development Strategy: Provides input to multiple aspects of the… more
- Merck & Co. (Rahway, NJ)
- …modalities and designing corresponding patient centric drug products through Phase 3 clinical development and line of sight to process validation and commercial ... launch.- This role reports to the Associate Vice President, Sterile Products Development, and supervise 3-4 directors and supervise a staff of approximately 40-50… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , HEOR is a significant contributor to the development ... and communication of HEOR evidence to demonstrate the value of Insmed's product(s). The Associate Director will work closely with HEOR team members and others… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director of Biostatistics is responsible for the statistical ... aspects for complex clinical trial(s) or indication product line. This role leads...and reporting of clinicals.Manage the timelines and oversee the quality of statistical analyses by CRO or internal teams.Undertake… more
- Catalent (San Diego, CA)
- …and external audits.Lead or support client audits along with the Director and Associate Director of Quality AssuranceManage a direct report and train the ... Job Title: Quality Assurance Associate , Analytical City: San...sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of research and strategic partnership contracting agreements. In collaboration with the Associate Director , the Associate Manager will support CMR's ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and external stakeholders Relationships This position reports to an Associate Director overseeing the contract management function… more
- Merck & Co. (Rahway, NJ)
- …a fast-paced job that provides both technical and project management responsibility. The Associate Specialist - Engineering Auto Eng position will report to the ... Director , Engineering, Automation Lead position and will be a...non-capital improvement projects, and the automation systems spanning various clinical manufacturing facilities. In this role, you will be… more
- Merck & Co. (Rahway, NJ)
- …fast-paced job that provides both technical and project management responsibility. The Associate Specialist - Manufacturing Automation position will report to the ... Director , Engineering, Automation Lead position and will be a...production, utility systems and associated infrastructure.- Responsibilities of the Associate Specialist - Manufacturing Automation include the following: Small… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affiliate, and/or in collaboration with global colleagues. Relationships Reports to the Associate Director Product Quality . Regularly interfaces with ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
