- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in ... on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking...teams and tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance… more
- Catalent (St. Petersburg, FL)
- …of process controls in all applicable areas of the manufacturing operation. The Senior QA Specialist will assist in organizing and prioritizing the activities and ... is responsible for actively identifying compliance enhancements/improvements and leading project to deliver solutions. Furthermore, this position will participate in… more
- Aequor (Thousand Oaks, CA)
- …remote schedule and be available at the committed times. Qualities/characteristics the hiring manager is looking for in candidates to work best with their team: ... Proactive, go-getter, detailed oriented, customer service oriented Things the hiring manager is looking for when reviewing resumes that stand out among the right… more
- 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
- 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)
- …PowerPoint, Word, Outlook, etc.)Education/ExperienceBachelor's Degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical ... field experienceOR Master's Degree +3 years of pharmaceutical, clinical drug development, project management, and/or medical field experienceOR PhD/PharmD… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Cardiometabolic Our Clinical Research and Pharmacovigilance team push the boundaries of global ... healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and...initiation, interim and close out visitsExperience as a CRA Manager , Lead CRA or Project ManagerRare disease… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …coordination. This position collaborates within global CSPV and cross-functional teams. As a project manager this position is responsible for working with the ... for planning, managing, and coordinating projects within DSI CSPV and global clinical safety and epidemiology function. Deliver the project according to… more
- Merck & Co. (North Wales, PA)
- …Outcomes Research, V&I GMSA, BARDS HEDS, and others as determined by senior leadership by providing overall operational support for research conducted in compliance ... to Suppliers and communicate with internal cross-functional teams to share project status and mitigations.Track timelines/deliverables and follow up on action items… 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
- Novo Nordisk Inc. (Irvine, CA)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …manage a lower complexity or regional project or be partnered with a more senior project manager in support of a larger, more complex drug development ... of these objectives. This position will report to the Sr . Director, Group Leader, GPM&L. Responsibilities Project ...of more complex projects in collaboration with a more senior project manager . Establishes and… more
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you. Senior Manager , US Alzheimer's Strategy and Lifecycle Planning Marketing will assist with ... business partners and external agenciesPotentially Lead or Co-lead cross-functional project teams involving Marketing, Sales, Managed Markets/Market Access, Legal,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …designated personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/ Sr . Manager Regulatory Affairs. Develop and maintain ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...Essential Functions Compile and submit responses to FDA communications. MANAGER , THERAPEUTIC AREA: Compile, submit and maintain applications (IND,… 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)
- …of studies within the clinical trial portfolio. Relationships Reports to a Senior Manager (or above) within North America Clinical Development (NACD). ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...across NACD by assuring training plans (NACD level & project level) are developed & deployed within a staff… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …access strategy for the assigned oncology asset(s). This person will report to the Sr Director, Global Oncology Value Pricing & Access, and will be responsible for ... and support the PRA strategies and tactics of additional indications. With manager oversight, the individual will lead global pricing strategy development, access… 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, ... etc., under the direction of Director, Compliance Policy, Training and Communications. Project manage various teams to build creative training programs from… 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)
- …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, ... the engine of development is the cross functional, empowered and agile Global Project Team (GPT), directly accountable to global Development governance. In this key… more
