- Eisai, Inc (Baltimore, MD)
- …generation, and when necessary, the re-engineering of Eisai "Best Practices" related to global submission management and dossier development in pursuit of ... want to hear from you. The Associate Director of Global Submission Management (GSM) is responsible for...requirements, and data standards (eg, CDISC).Extensive experience with Regulatory Information Management (RIM) systems and Document … more
- Insmed Incorporated (NJ)
- … for assigned programs. This role will provide regulatory input to global cross-functional project teams throughout product development and submission ... be determined upon evaluation of credentials and experience.What You'll Do: Lead development and execution of global regulatory strategies for clinical,… more
- Eisai, Inc (Nutley, NJ)
- …labeling repository within Eisai's electronic document management system for all global labels at various stages of development , review and approval. Manage ... for all employee-related activities throughout the year, including performance management and development .Maintain expertise regarding key labeling requirements… more
- Merck & Co. (North Wales, PA)
- …overall category management for the packaging category led by the global COE's, either directly (for local managed categories) or indirectly through strong ... and mentors his/her teams as needed.Required Skills: Direct Materials, Global Category Management , Indirect Materials, Leadership, Negotiation, People… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …establishment processes in collaboration with GMP Quality System function. Supports the development and implementation of key global /regional QA GMP Standards, ... capacitation program for GMP QA Auditors. Interacts with local, regional and global stakeholders sharing reports and related information about audits,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Global QA Strategy and Operations to ensure alignment and execution of global initiatives. The incumbent will oversee the development and promotion of the ... future team, while developing talent through mentoring and high expectations.Develop, Execution and Management of Global R＆D PV QA Mid-Term Strategy and Business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Marketing, Supply Chain, Finance, Market Access, Medical Affairs, and Clinical Development .Lead alignment efforts across global and regional stakeholders on ... management , understanding, anticipating, and fulfilling their insight/ analytical information requirementsAbility to influence stakeholders Daiichi Sankyo, Inc. is… more
- Eisai, Inc (Nutley, NJ)
- … development and execution of regulatory strategies for products under development , post-approval activities, and life-cycle management , with a particular ... and post-approval applications. Essential Functions Provide strategic leadership in the development , registration, and life-cycle management of products in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and Global harmonization of the supplier qualification program, including management of the electronic systems for this program.Work with External Quality and ... Legend Biotech is a global biotechnology company dedicated to treating, and one...harmonization and alignment across all functions and sites.Support the development of the GMP Compliance program related to clinical/… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Leadership:As a member of the Talent Acquisition Leadership Team, contribute to the development of the Global Talent Acquisition strategy, policies and processes ... and manage the budget and human resources in the Global Experience Hire Early Careers TA teamProgram Development...DS' employer brand in the marketCollaborate with Head of Global Talent Acquisition and Human Resource Information … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical affairs projects within a specific compound or indication.ResponsibilitiesLeads the development of the Global Medical Affairs strategy and execution ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Eisai, Inc (Nutley, NJ)
- …analytic background, desiring more exposure to reimbursement and value strategy development . Essential Functions Key deliverables development : Global economic ... and oncology, with a strong emphasis on research and development . Our history includes the development of...your profile, we want to hear from you. The Global Associate Director, will lead projects and contribute to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director, Technical Operations within Global Clinical Supply (GCS) is responsible for technical leadership in support of GCS global facilities ... equipment-based challenges when required.- The technical lead may also manage global infrastructure projects to establish, upgrade, and improve the GCS packaging,… more
- Merck & Co. (North Wales, PA)
- …the entire product lifecycle.- Primary Activities: Effective analysis and report programming development and validation utilizing global and TA standards and ... Management , Data Modeling, Numerical Analysis, Outcomes Research, Project Management , Project Planning, SAS Macros, Software Development , Stakeholder… more
- Merck & Co. (Rahway, NJ)
- …Strategic Business Consulting, Strategic CollaborationsPreferred Skills: Business Development , Commercial Awareness, Industry Knowledge, Innovation, Portfolio ... Job Description Director, Commercial Strategy Development The Enterprise Strategy Office (ESO) develops, implements, and drives enterprise strategy in support of our… more
- Insmed Incorporated (NJ)
- …have an MD, DO, or foreign equivalent along with 10+ years of global experience in neurology clinical development within the pharmaceutical/biotech industry. ... across multiple phases of clinical research (Phases 1-3).5+ years of management experience within clinical development .Prior Gene Therapy experience.Clinical… more
- Insmed Incorporated (NJ)
- …the Senior Director, Program Management , you'll utilize best-in-class program management and drug development expertise to provide executional oversight and ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...development plan. The role involves both hands-on program management and a strategic mindset to drive the execution… more
- Insmed Incorporated (NJ)
- …in. Are you?About the Role:We're looking for a Senior Manager, Supplier Relationship Management on the Global Supply Chain & Logistics - Supplier Relationship ... patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare… more
- Insmed Incorporated (NJ)
- …future of science, we're in. Are you?About the Role:We're looking for a Quality Management System (QMS) Specialist on the Analytical Development team to help us ... patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare… more
- Insmed Incorporated (NJ)
- …diseases. In this role, you'll be reporting to the Sr Director, Information Technology Program Management .The Insmed Summer Internship Program is designed ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...pursuing a Bachelor's, Master's, or advanced level degree in Information Systems, Business Administration , Management ,… more
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