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See allKey Responsibilities:
- Serve as key legal partner and SME to commercial and medical teams, providing practical legal advice on pre-launch activities, launch strategy, and ongoing operations.
- Oversee outside counsel and conduct diligence for financings and business development activities.
- Review external corporate content such as press releases.
Compliance Program Support:
- Provide thought partnership to Compliance to advise commercial, medical, and advocacy teams on compliance obligations.
- Partner with Compliance to evolve the U.S. compliance program consistent with company size and scope.
- Support development and enhancement of compliance policies and SOPs related to AKS, FCA, and industry codes.
Qualifications and Experience:
- JD required with 12+ years of relevant legal experience in the biopharmaceutical industry.
- Deep knowledge of FDA promotional regulations, Anti-Kickback Statute, and False Claims Act.
- Experience supporting product launch planning and cross-functional review committees.
Orca Bio
Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies to provide better survival rates with fewer risks. The company maintains a start-up culture of camaraderie and leadership by example, with a focus on passion, courage, and integrity.