- Taiho Oncology (New York, NY)
- …with a dynamic and growing Medical Affairs Department. Position Summary: The Senior Medical Science Liaison ( Sr . MSL) is a field-facing representative ... Sr . Medical Science Liaison New Jersey, USA New...product(s) and compounds to ensure awareness and understanding. Provides high- quality scientific information to HCPs. Serves as a conduit… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical trial performance and quality metrics and share with study team, Operations Program Lead, and Sr . Director for the compound, on regular basis and ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and focus to agreed strategy; Coordinates clinical activities across the project ; Represents IPT to Sr . ManagementAdditional non-study related activities: ... and immune disorders.SummaryOversees a number of trials of a multinational program in a specific indication, ie, multiple multinational phase II/III clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …language for IB; Documents ongoing MM review of data for safety (with CSPV) and quality at project levelStudy Strategy: For Phase 2 and Phase 3 registrational ... coordination and focus to agreed strategy; Coordinates clinical activities across the project ; Represents IPT to Sr . ManagementPeople Management: Leads large… more
- Aequor (Raleigh, NC)
- …more high-level, complex non-technical projects within the constraints of scope, quality , time, and cost, to deliver specified requirements, including: Developing ... processes and find innovative solutions to drive efficiencies. Collaborating with SP&O Sr Manager to support function wide initiatives including crafting and running… more
- Novo Nordisk Inc. (Boulder, CO)
- …to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our ... are driving change. Are you ready to make a difference? The Position The Senior Manager of Specialty Raw Materials Manufacturing is responsible for ensuring a steady… 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 3-4 ... As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the… more
- Catalent (Harman, WV)
- Senior Director, Supply Chain Position Summary: The Senior Director, Supply Chain is responsible for leading the supply chain organization for Catalent Maryland. ... online.Reporting to the Vice President and General Manager, the Senior Director Supply Chain directs all facets of supply...committed to a Patient First culture through excellence in quality and compliance, and to the safety of every… more
- Merck & Co. (Rahway, NJ)
- …without formal authority; ability to influence and present ideas to senior leadershipExcellent communication, presentation, negotiation, project management, and ... tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position interacts extensively with… more
- Merck & Co. (North Wales, PA)
- …safety evaluation. The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with ... timely and high quality deliverables. For assigned projects the position serves as...departmental SOPs and good programming practices.Maintain and manage a project plan including resource forecasting.-Coordinate the activities of a… more
- Merck & Co. (South San Francisco, CA)
- …motivated, and curious scientist for our Modeling and Informatics group. As a Senior Scientist (R3), you will be part of a multidisciplinary team, collaborating with ... to discover new drugsSpearhead the modeling and informatics initiatives on project teams, strategically applying computational methodologies throughout all stages of… more
- Merck & Co. (North Wales, PA)
- …design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements.Collaborates with the statistical programming staff to ensure ... available software for planned analyses and ascertains needs for potential program development of novel statistical methodology.Analyzes data and interprets results… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …that CMC documentation is complete, well organized, scientifically sound, of a high quality , aligned with the current regulations, and presented in a manner that ... facilitates Health Authority reviews.- Supports company`s GMP Change Management Program . Evaluates CMC changes for portfolio biologics and determines filing… more
- Merck & Co. (Rahway, NJ)
- …and compose complex presentations and both intra- and inter-divisional communications.-Optimize program execution inclusive of Scope, Quality , Timeline and ... scientific-related discipline strongly preferredRequired Experience and Skills:--Research, manufacturing, and project / program management experience in pharma Demonstrated ability… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical trial performance and quality metrics and share with study team, Operations Program Lead, and Sr . Director for the compound, on regular basis and ... and execution (from planning start-up, conduct, reporting and close out) including timeline, quality and budget. A key focus will be the oversight of and… more
- Novo Nordisk Inc. (Boulder, CO)
- …to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our ... control and deviation processes at NN Boulder, specifically in the role of Quality Assurance (QA) subject matter expert (SME).This position is also responsible for… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …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 ... 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)
- …drug development experience ideally including time in role such as a Global Project Leader at Sr . Director level or equivalent preferred- Relevant therapeutic ... clinical trial portfolio and submissions are delivered to time, quality , and cost. The teams reporting into this role...a key point of escalation for issues impacting across program for both internal and external stakeholders. Responsible for… more
- Merck & Co. (Rahway, NJ)
- …with ICH/GCP and country regulations, company policies and procedures and-with quality standards internally and externally.Under the oversight of the CRD(Clinical ... interns-delegated to the Clinical Operations team based on the Internship program , while-properly managing situations of low or non-performance.The role will work… more
- Merck & Co. (Rahway, NJ)
- …and aspiration of our Company's digital (Chemistry, Manufacturing, and Controls) CMC program to set the foundation for a digital continuum from development to ... manufacturing for our products and processes. The digital CMC program is a multi-year investment, and will need to...the full technology stack across of Operations, Supply and Quality .- The resultant standard architecture must fulfill the needs… more
