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This role will collaborate with Pharmaceutical Development, Regulatory, Supply Chain, Quality, and other departments to meet all packaging requirements, including but not limited to; regulatory requirements, engineering studies and line qualification, storage and distribution testing and USP Testing, to ensure a robust supply of finished goods to patients Directed end to end packaging validation a
Posted 1 day ago
Conceive, design, and help deliver cloud native solutions for Clinical IT's Patient Data & Analytics team by partnering with key business stakeholders and IT delivery (e.g. Infrastructure) teams Research, evaluate, and recommend emerging technology concepts, vendors, and products for application in drug development and outcomes research Provide technology recommendations and architectural reviews
Posted 1 day ago
Processes requisitions in a timely manner ensuring best quality, service, quantity, delivery and cost in accordance with organizational objectives and sourcing strategies Process Orders through internal Chemical Ordering system supporting R&D departments Review, process and execute Capital Equipment Orders Completes the entire Procure to Pay cycle by working closely with the Receiving and Accounts
Posted 1 day ago
The Principal Manager, Clinical Quality Management will be a motivated individual working in a dynamic, cross functional environment within the Global Clinical Operations team. This position will be responsible for training, process management and inspection readiness activities supporting Global Clinical Operations. This position will report directly to the Director, Clinical Quality Management.
Posted 1 day ago
Participates in the development of Study Protocols, Investigator's Brochures, Clinical Development Plans and other key study documents in conjunction with other line functions and with minimal guidance Serves on cross functional Study Execution Teams (SET) for assigned trials, working with other team members to achieve efficient, high quality study execution Participates in the preparation of
Posted 1 day ago
Perform cGMP analytical data review for various techniques such as HPLC, GC, KF, TOC, IR and dissolution to ensure adherence to established methodology, procedures and SOPs Review laboratory instrument qualification and requalification packages executed by vendors Compile and summarize analytical data in various physical and electronic report formats Review laboratory equipment logbooks Ensure all
Posted 1 day ago
Support strategic alignment of the assigned clinical program/product working cross functionally and partnering with other key functions as outlined Provide input and contribute to the global Therapeutic Area strategic imperatives, Medical Affairs objectives and annual brand tactical plans Support development of Study Protocols, Life Cycle Management Plans and other key study documents in conjuncti
Posted 1 day ago
Responsible for developing the clinical biomarker strategy for programs and implementing the biomarker plan during clinical development. Collaborate with Research and Translational Medicine on development of translational biomarker plans. Collaborate with Clinical Study Teams and colleagues in Translational Medicine and Clinical Development to ensure appropriate inclusion of Clinical Biomarkers in
Posted 1 day ago
Prepare the clinical development plans, in conjunction with other relevant functional areas Participate in the development of study protocols, statistical analysis plans, investigator's brochures, and other key study documents in conjunction with other line functions and with minimal guidance Serve on cross functional study teams for assigned trials, working with other team members to achieve
Posted 1 day ago
Define a clinical development strategy and prepare the clinical development plans, in conjunction with other relevant functional areas Participate in the development of study protocols, statistical analysis plans, investigator's brochures, and other key study documents in conjunction with other line functions and with minimal guidance Lead the Project Team, and work with cross functional team
Posted 1 day ago
Provide leadership and oversight of Safety Team(s) for products within assigned therapeutic area(s), including pre FIH activities, benefit risk assessment, and strategy for DSTs. Coordinate and oversee safety signals detection, in accordance with Vertex signal detection practices. Collaborate with Clinical Leaders to develop and implement appropriate Risk Management procedures/plans for each produ
Posted 1 day ago
The primary responsibility of the Associate Director, Global Medical Communication, Triple Combination will oversee the execution of the brand specific medical communication plan in collaboration with the Director, Triple Combination Medical Communications and Lead Medical Director. GENERAL RESPONSIBILITIES AND REQUIRED SKILLS He/she is responsible for overseeing the strategic execution of publica
Posted 1 day ago
The primary responsibility of the Associate Director, Global Medical Communication, Triple Combination will oversee the execution of the brand specific medical communication plan in collaboration with the Director, Triple Combination Medical Communications and Lead Medical Director. GENERAL RESPONSIBILITIES AND REQUIRED SKILLS He/she is responsible for overseeing the strategic execution of publica
Posted 1 day ago
Perform in process, release, and stability testing independently following established methodology, procedures and SOPs Participate in executing method validations and/or method transfers Troubleshoot analytical methods with the assistance of supervisor when necessary Maintain accurate testing records and adhere to cGMP/GDP expectation May be required to author and review data, SOPs, analytical me
Posted 1 day ago
Departmental expert for Vertex's internal technologies such as iProcurement, SharePoint, Concur, and Vlearn Contact for department projects PON, LaunchPad and manages project pipeline Training Coordinator for Biometrics (maintains and builds department CURs) Manages meetings, internal and off site, including meeting set up and reschedules, catering orders, the day of support Ensures timely process
Posted 1 day ago
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