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providing preliminary assessments and recommendations to the Medical Lead. Analyze and synthesize information to assess issues relating to protocol conduct and/or individual subject safety. Assist in
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Clinical Scientist or other closely related role within Clinical Development. Key Responsibilities: Development of key documents including clinical development plans, protocol concepts and full protocols
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and fee for service contracting Build an understanding of the specialty pharmacy landscape including hub services models, limited distribution networks, and patient support program integration
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evidence plans across therapeutic areas Contribute to the design and execution of RWE and HEOR studies, including concept documents, protocols, statistical analysis plans, and study reports Contribute
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clinical trial protocols with the patient experience at the forefront. Eidos is an affiliate that operates under the BridgeBio umbrella. We are focused on the treatment of ATTR-CM, and our product
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or supporting grant review processes • Supporting clinical development activities, such as protocol development, contract research organization engagement, medical writing for submissions, and site qualification
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, EMA, and PMDA meetings. Labeling & Core Documentation: Support development and maintenance of the Investigator’s Brochure, protocols, ICFs, and global product labeling, including CCDS, USPI, and EU SmPC
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to develop timely, accurate, and scientifically balanced responses to unsolicited medical information inquiries · Network across the Medical Affairs organization to gain a thorough understanding of
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for regulatory submissions LEAD THE DEVELOPMENT of a method for researching and communicating changes and meaningful trends in the regulatory environment in the US and pertinent international jurisdictions NETWORK
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biotechnology, nanomedicine, immunology, health informatics, and drug discovery · Network with local residents and other Northeastern fellows via professional development programs, teaching seminars, and