The Associate Director, Regulatory Affairs will serve as a Health Authority liaison and key member of project teams.... This individual will establish and communicate regulatory strategies for development programs and coordinate the timelines, generation...
The Steely Groupand ICH/GCP requirements. Establishes collaborative working relationships with internal members of the Clinical Development group... reports to the Director of Clinical Operations and is an individual contributor to the successful achievement of the Clinical...
The Steely GroupLocated in our client's Cambridge, MA office, the PD Associate Scientist will work to provide testing support... for commercial process development and process characterization studies for clinical candidate molecules in the pivotal stage...
The Steely GroupThe Director, Regulatory Operations functions as the subject matter expert providing leadership in all aspects..., publishing, quality control, dispatch, tracking and archival activities to enable successful IND, NDA, BLA applications and the...
The Steely GroupAn individual contributor-level role that ensures efficient and effective administrative operations to the Clinical..., such as organizing and scheduling meetings. Serves as the point of contact with service providers (SPs) for all tasks associated...
The Steely GroupYou will have the opportunity to contribute to an early drug discovery program in the Targeted Protein Degradation... space. This position offers the unique opportunity to directly impact a growing portfolio of targeted therapies in a fast...
The Steely Groupfor one pipeline product. Reporting to the Vice President, Sales and Marketing, the person in this role will develop and manage brand... and launch plans for the brand in the US market, collaborate with cross-functional stakeholders to develop and successfully...
The Steely GroupThis position offers the opportunity to impact a growing portfolio of targeted therapies in a fast-paced and innovative...
The Steely GroupReporting to the Director, Clinical Operations, the Senior Study Manager, Clinical Operations is responsible... for providing operational oversight, leadership, and strategic input for the execution of the assigned clinical studies (Phases I-IV...
The Steely GroupOur client is looking to add a Director of PV Regulatory leader to its team on a permanent basis. Reporting to the PV... Division Director at company headquarters in Japan, this is a hybrid role expected to be in the Cambridge, MA office 3 days...
The Steely GroupThe Director of Pharmacovigilance (DPV) leads and/or oversees safety and benefit-risk management for assigned product... responses to regulatory inquiries on product safety issues for assigned product(s). The DPV works closely with the Global Safety...
The Steely Group