
11 - 50 employees
š„ Healthcare
š¼ Consulting
š½ļø Food & Beverage
Healthcare ⢠Consulting ⢠Food & Beverage
Pulmovant is a company committed to transforming the lives of patients with pulmonary diseases by developing innovative therapies. Their lead product, mosliciguat, aims to provide a once-daily, inhaled treatment for pulmonary hypertension, distinguished by its novel sGC activation mechanism. With a singular focus on addressing the unique needs of patients suffering from pulmonary conditions, Pulmovant is engaged in extensive clinical trials to advance its pioneering treatment options.
š„ 13 hours ago
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11 - 50 employees
š„ Healthcare
š¼ Consulting
š½ļø Food & Beverage
Healthcare ⢠Consulting ⢠Food & Beverage
Pulmovant is a company committed to transforming the lives of patients with pulmonary diseases by developing innovative therapies. Their lead product, mosliciguat, aims to provide a once-daily, inhaled treatment for pulmonary hypertension, distinguished by its novel sGC activation mechanism. With a singular focus on addressing the unique needs of patients suffering from pulmonary conditions, Pulmovant is engaged in extensive clinical trials to advance its pioneering treatment options.
⢠Execute clinical supply chain activities supporting Pulmovant clinical studies globally ⢠Coordinate clinical packaging, labeling, and distribution operations ⢠Manage inventory and logistics for the clinical program ⢠Serve as the subject matter expert for clinical drug supply throughout all clinical trial phases ⢠Support implementation of global clinical inventory management, supply planning, and distribution systems ⢠Manage vendors and performance metrics ⢠Support clinical supply activities for ongoing and new clinical trials, including protocol demand forecasting, pharmacy manual drafting, trial monitoring, initial and resupply planning, and distribution ⢠Coordinate with Clinical Operations, CROs, and sites to support enrollment and participant dosing ⢠Coordinate contract manufacturing packaging, labeling, and international shipping/distribution of investigational medicinal product ⢠Partner with CMC, Clinical Operations, QA, and Regulatory to develop kits and label text for multiple countries/regions ⢠Lead or participate in IXRS development and system maintenance ⢠Assist with risk mitigation plans and inspection-readiness process development ⢠Support vendor selection and CMO qualification with Regulatory Compliance and QA ⢠Coordinate global material logistics and movement with the CMC team
⢠Minimum of 5 years of related experience in the pharmaceutical industry ⢠At least 2 years of direct experience in Global Clinical Supply Management ⢠Prior investigational drug product experience ⢠Prior GCP training is required ⢠Recent industry experience with clinical supplies or clinical operations is preferred ⢠Demonstrated experience with global clinical supply forecasting, planning, packaging, labeling, inventory management, IVRS systems, and clinical trial designs (randomized, double-blind, placebo-controlled) ⢠Thorough knowledge and understanding of cGMP, ICH/cGXP guidelines, and global Health Authority requirements ⢠Proficiency in software applicable to IVRS/IWRS, Excel, PowerPoint, and MS Project ⢠Good organizational, communication, and presentation skills ⢠Effective project and time management skills ⢠Ability to work under pressure ⢠Ability to use a computer and communicate via phone, video, and electronic messaging ⢠Ability to engage in problem solving, analysis, dialogue, collaboration, and maintain general availability during standard business hours
⢠Remote work environment ⢠Equal employment opportunities and protection from discrimination and harassment
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