Provide subject matter expertise to teams for global disclosure strategies of clinical documents under regulatory requirements.
Manage planning, preparation, and quality control for disclosures, including oversight of vendor deliverables.
Lead development of standard processes and technological solutions to ensure compliance with disclosure regulations.
Pfizer is a global biopharmaceutical company dedicated to discovering and developing innovative therapies. As a large multinational employer with a culture of individual ownership, it employs tens of thousands of people and fosters a collaborative and inclusive environment.
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.
Supports the strategy and execution of US Public Affairs activities, with a focus in cystic fibrosis.
Monitors state legislation and identifies substantive policy and political opportunities and risks to the company’s business.
Develops plans, goals, processes, and logistics for projects, gaining cooperation and alignment.
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. Vertex is consistently recognized as one of the industry's top places to work, with global headquarters in Boston's Innovation District and international headquarters in London.