- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine ... subsidiaries in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Data Science and Evidence (CDSE) Real World Evidence (RWE) team. Relationships The Senior Manager reports directly to a Senior Director within the ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new… more
- Merck & Co. (North Wales, PA)
- …Summary: This position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the ... cross-functional team.Job Responsibilities: Responsible for leading specific aspects of clinical /scientific execution of clinical protocol(s). This may… more
- Merck & Co. (Rahway, NJ)
- …executing end to end Data Management activities with the support and oversight of a Senior Clinical Data Manager (SCDM)/Lead Clinical Data Manager ... operational project assignments under the direction of an Operations Manager (OM). - Your Fellowship Project - - You...Fellowship - Mentoring & networking opportunities within and beyond Clinical Trial Operations Exposure to Senior level… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities ... the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's compliance… more
- Merck & Co. (North Wales, PA)
- …knowledge in Microsoft office or similar (Excel, PowerPoint, Word, Outlook, etc.) Education /Experience:Bachelor's Degree +5 years of pharmaceutical, clinical drug ... This position leads the operational planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Epidemiology OperationsSupport the Lead Epi Scientists by providing overall operational support for ... Operating Procedures (SOPs). Manages several complex activities and study types.Our Clinical Research and Pharmacovigilance team push the boundaries of global… more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately ... system#LI-HC1#IND-123Eisai Salary Transparency Language:The base salary range for the Senior Manager , Medical Writing is from :126,300-165,800Under current… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Quality Senior Specialist provides expertise in the coordination of resources and equipment pertaining to qualification/validation activities ... supporting the vaccine expansion facility. Primary Responsibilities: The Quality Senior Specialist will be responsible for comprehensive management of all activities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Executes statistical activities for low to ... analyses execution, quality control, and data derivation; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Interaction & Collaboration level: Requires interaction with vendors and key senior stakeholders at Sr manager and director level in ... other research areas centered around rare diseases and immune disorders. Summary: Manager , Sales Training and Development - Oncology serves as the training subject… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewBD Manager for Competitive Intelligence and commercial evaluation of Business Development ... information related to new product acquisitions or merger to senior managementIn-depth understanding of commercial forecasting, market access, pricing, launch… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... to support drug development processes and global submissions as required for clinical trials. These include developing and validating SAS programs for clinical… 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 ... developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process ... As a result, this role will need to partner closely with teams and senior leaders from across Regulatory Affairs, as well as cross-functional stakeholders (eg, RA… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …organization and will work regularly with all business areas (Sales, Marketing, Clinical , TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT, ... materials that pertain to training objectives for use at Senior Leadership meetings.Special Projects/Change ManagementAssist the Director in the implementation… more
- Novo Nordisk Inc. (Durham, NC)
- …technology & processes in accordance with relevant project plans & timelines. Relationships Senior Manager , Quality Control - OFP. Essential Functions Accuracy & ... of study from an accredited university required or an equivalent combination of education and experience May consider an Associate's degree in chemistry or relevant… more
- Novo Nordisk Inc. (Poughkeepsie, NY)
- …goals are being properly executed within territory. Relationships Reports to the Obesity Education Manager . Represents the organization as a prime contact for ... ready? The Position This position responsible for the delivery of Obesity education for relevant local stakeholders, to empower proactive, systematic and chronic… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader to ensure a high performing Clinical Sub-team and ... to drive the development and delivery of the clinical development plan in alignment with the product development strategy.Manages the team meetings including… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. Summary The Global Team Leader, is a senior , cross-functional leader in Daiichi Sankyo's Global R&D organization. At Daiichi Sankyo, ... have to lead a complex, global team in charge of a global clinical program designed to support registration and develop value-enhancing life-cycle strategy. The GTL… more
