- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … study (-ies) utilizing Microsoft Project or equivalent.Lead the creation of the cross- functional Clinical Study Oversight Plan (CSOP) under the guidance of the ... Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction...The Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution ... review, tracking of milestones as per contract). Ensure the global clinical operations systems for management of...study activities with other relevant GOMA functions and the Global Medical Affairs Team. Regional and Functional … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilitiesSummaryThe Associate Director, Global Oncology Clinical Development (GOCD) Functional ... strong presentation skills and be comfortable interacting with many different global functional groups, external vendors, as well as leadersResponsibilities… more
- Merck & Co. (Rahway, NJ)
- …alignment with the goals, purpose and mission of our Company Research Labs, Global Clinical Development (GCD) and GCTO.Ability to identify problems, conflicts ... Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed. Performs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with Clinical Safety Scientist Product Lead, Product Safety Lead (PSL), Clinical Safety Physician(s), and cross- functional team(s) in support of benefit risk ... with Clinical Safety Scientist Product Lead, Product Safety Lead (PSL), Clinical Safety Physician(s), and cross- functional team(s) in support of benefit risk… more
- Merck & Co. (Rahway, NJ)
- …forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug ... Job DescriptionOur Company is a global health care leader with a diversified portfolio...Substance, Drug Product, Analytical Development, and Clinical Supply across all modalities. We are interdependent across… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...support and may manage day to day functional excellence activities to include, but not limited to,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …is filed/archived according to applicable Daiichi Sankyo and regulatory requirements. Functional Expertise:Reviews/approves clinical study related documents (eg, ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (North Wales, PA)
- … studies.-Under the direction of the Program Lead, you will collaborate with global , cross- functional team-members including clinical directors and study ... the clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …As a project manager this position is accountable for partnering with the Global Team and Global Clinical leader to ensure effective team operations ... project or be partnered with a more senior project manager in support of a larger, more complex drug...complex or regional projects (within the scope of the Global Development Process and Functional Procedures) or… more
- Merck & Co. (Rahway, NJ)
- …CRA/CRA and/or CRA Manager , acts as primary site contact and site manager -throughout all phases of a clinical research study, taking responsibility of ... research, phases of clinical -trials, current GCP/ICH & country clinical research law & guidelines.-Good understanding of Global , Country/Regional CRA… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, ... teams and senior leaders from across Regulatory Affairs, as well as cross- functional stakeholders (eg, RA CMC, R&D Excellence, Clinical Operations,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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. ... Global Team Leaders.Responsibilities- Creating and leading a high performing, cross- functional global project team composed of representative of asset… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant… more
- Aequor (NJ)
- …Medical Affairs (MA), Regulatory, CMC, QA, Packaging Vendors, CRO's, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ensure all ... 100 % remote Manager prefers local candidates (will consider non local...cross- functional teams. Proactively defining, planning, and communicating clinical supply strategy in support of global … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and support the PRA strategies and tactics of additional indications. With manager oversight, the individual will lead global pricing strategy development, ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical ... reviews and MSA discussions of External Vendors by engaging with key cross- functional stakeholders ( Clinical Operations, Clinical Biomarkers, QCP, etc.)… more
- Novo Nordisk Inc. (Cincinnati, OH)
- …same. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal ... development. Are you ready to realize your potential? The Position The Manager - Pharmacy Execution will work with Regional Business Directors (RBDs) and Trade… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... Client interface, Lab Investigations, Deviations, Complaints, etc. The focus of each QA Manager may be dependent upon the needs of the business and structure of… more
- Eisai, Inc (NJ)
- … areas to obtain all applicable source materialCollaborate with cross functional teams like Clinical Research, Biostatistics, Statistical programming, Clin ... want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical...incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the… more
