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Associate General Counsel (Commercial)

1 month, 2 weeks ago
United States
Full-time
Lead
Legal Counsel
Legal
Apply Now
Orca Bio

Orca Bio

Orca Bio is revolutionizing allogeneic cell therapy with next-gen therapies for better outcomes and fewer risks, transforming lives through precision and innovation.

Pharmaceuticals
51-250
Founded 2016
$192M raised
View All Jobs 4

Description

  • Serve as the primary legal partner and subject matter expert for commercial and medical affairs teams.
  • Provide legal guidance on pre-launch and launch activities, including medical programs, disease awareness, sales, marketing, marketing analytics, patient advocacy, advisory boards, and incentive compensation.
  • Advise market access teams on pricing, reimbursement, distribution, contracting structures, payer engagement issues, PIE, and FDAMA 114.
  • Draft and negotiate market access and patient support agreements and advise on legal issues related to patient support and hub services.
  • Review content and messaging for Promotional Review Committee, Medical Legal Regulatory Review Committee, Publications Review Committee, ISR reviews, grants, sponsorships, and similar bodies.
  • Train applicable personnel on legal and compliance requirements.
  • Oversee outside counsel and support diligence for financings and business development activities.
  • Review external corporate content such as press releases.
  • Partner with Compliance to advise commercial, medical, and advocacy teams on compliance obligations and to evolve the U.S. compliance program.
  • Support development and enhancement of compliance policies, SOPs, training, ethics materials, and procedures related to AKS, FCA, and industry codes.

Requirements

  • J.D. required.
  • 12+ years of relevant legal experience in the biopharmaceutical industry, with biotech experience preferred.
  • Deep knowledge of FDA promotional regulations, the Anti-Kickback Statute, the False Claims Act, OIG Guidance, and industry codes.
  • Experience reviewing promotional and medical materials.
  • Ability to interpret and apply healthcare laws to complex business plans.
  • Experience supporting product launch planning and cross-functional review committees; experience building for a first U.S. launch preferred.
  • Strong business partnering skills with the ability to balance risk and business goals.
  • Excellent communication skills.
  • Ability to manage multiple priorities in a fast-paced environment and adapt in a demanding startup culture with evolving processes.

Benefits

  • Competitive annual salary based on experience, education, location, and other job-related factors.
  • Pre-IPO equity for full-time employees.
  • Annual bonus eligibility.
  • Medical, dental, and vision insurance.
  • PTO and parental leave benefits.
  • 401(k) plan.
  • Life insurance and accidental death and disability coverage.
  • Subsidized daily lunches and snacks at on-site locations.

Interested in this position?

Apply directly on the company website

Apply Now

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