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Actively manage analytical method transfer and method validation activities for drug substances at company's CMO to ensure the timeline and quality standards are met.
Provide interpretation of regulatory authorities' feedback, policies and guidelines to company personnel. Support company during regulatory authority inspections on designated programs.
Plan and coordinate continuous improvement of quality processes and systems that assure compliance of clinical study - related activities conducted by company and in collaboration with GBT contract research organizations.
Manage process and preparation of investor outreach activities including: participation in IR conferences, non-deal roadshows, teleconferences, Analyst Day, and annual shareholder mailing and meeting.
Ensure all safety reports are triaged, processed, reviewed and submitted accordingly per global regulatory requirements and Global Blood Therapeutics (GBT) standard operating procedures.