Radius Health, Inc. is more than just a biopharmaceutical company. We are a growth company with audacious ambition for ourselves, our teams and for the patients who take our medicines. Radius seeks passionate, dynamic team players, problem-solvers and risk takers. We reward both imagination and those who mobilize big ideas. At Radius, it’s about high-performing teams boldly engaging an ever-changing healthcare landscape to positively impact generations of families. Radius is seeking outstanding candidates across a range of commercial roles. We invite you to join our revolution.
The Senior Director, GCP Quality Assurance applies knowledge, expertise and global experience in the principles and applications of GCP, GLP and GVP Quality ICH guidelines to lead related vendor and internal audits, procedure development, identification and monitoring of deviations, investigations and CAPAs, and Inspection Readiness.
Radius Health, Inc. is seeking a GMP Quality Assurance Manager who has the ability to perform in a fast-paced environment under tight deadlines and who has expertise in assuring compliance with FDA CFR Part 210 and 211, FDA 21 CFR Part 820, EU GMP Volume 4, ISO 13485, ICH Q7, Q8, Q9 and Q10.
The incumbent will have responsibility to ensure that all quality management functions are maintained according to GMP requirements. The incumbent will execute Quality Assurance and quality system activities with a focus on Radius’ late-phase development and commercial products, ensuring consistent application of cGMPs. Specifically, they will have responsibilities for execution of quality systems related to complaint management, complaint investigations, CAPA and deviation management and change management.
The Senior Clinical Trial Manager manages and oversees clinical operation activities across a single clinical program or group of related studies, and ensure all assigned operational trial deliverables are met according to timelines, budget, operational procedures, quality standards, SOPs and business guidelines.
US-MA-Waltham | US-NJ-Parsippany | US-New York
The Associate Director or Director, Biostatistics will be responsible for all statistical activities of assigned clinical studies. The incumbent will be the statistical lead and point-of-contact on statistical activities for the clinical study teams.
Potentially able to work remote!