Lead life sciences customers in the rapid configuration and implementation of Vault Safety.
Define strategies, business processes, and implementation program(s) for deploying Vault Safety across an organization.
Provide subject matter expertise on Drug Safety and Pharmacovigilance for customers and project teams.
Veeva Systems helps life sciences companies bring therapies to patients faster via industry cloud. They are one of the fastest-growing SaaS companies, surpassing $3B in revenue, and committed to balancing the interests of customers, employees, society, and investors.
Serve as a regulatory representative on multidisciplinary program teams, supporting health authority interactions and global submissions for biologics in development.
Contribute to regulatory plans across the product lifecycle, from early clinical development through registration and lifecycle management.
Manage submission activities including INDs/CTAs, amendments, annual reports, and briefing documents, ensuring compliance with US/EU regulations and ICH guidelines.
Oruka Therapeutics (Nasdaq: ORKA) develops novel biologics to treat chronic skin diseases like plaque psoriasis, aiming for high rates of complete clearance with dosing as infrequently as once or twice per year. As a small startup building its core team, we seek top talent passionate about making a difference and contributing to an engaged, inclusive, and positive company culture.
Develops and directs global regulatory strategy to obtain and maintain product approvals across key regions.
Serves as primary regulatory contact for health authorities and leads cross-functional regulatory sub-teams.
Identifies regulatory risks and provides strategic guidance for product development and lifecycle management.
Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients with severe metabolic and endocrine disorders. It is a publicly traded company driven by scientific innovation, collaboration, and integrity.
Serves as the medical monitor for clinical trials and assists in resolving major issues that may affect their assigned studies.
Partners with the Clinical Scientist, Data Manager, Pharmacovigilance Scientist, and other members of the study team to conduct the clinical studies.
Provides expert opinion and review for creation of key study documents, including clinical study protocols, safety and medical monitoring plans, charters, and informed consent forms.
Cullinan Therapeutics is a biopharmaceutical company developing potential first- or best-in-class, high-impact therapies for cancer and autoimmune diseases. They have a clinical-stage pipeline built on a rigorous scientific approach and purposeful innovation, and are advancing its mission to deliver new standards of care for patients.