Associate General Counsel (Commercial)

compensation for commercial personnel and other business activities Counsel market access on pricing, reimbursement, distribution and contracting structures; advise on payer engagement issues including PIE and FDAMA 114; draft and lead the development of market access and patient support agreements; advise patient support team on legal issues related to patient support and hub services Act as Legal representative reviewing content and messaging on Promotional Review Committee, Medical Legal Regulatory (Medical) Review Committee, Publications Review Committee, ISR reviews, grants and sponsorships committees and similar bodies Training of applicable personnel Oversee outside counsel; conduct and respond to diligence for financings, business development activities and the like as needed; and review other 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 and aligned with company values Partner with Compliance to coordinate training activities including legal and compliance

responsibilities, ethics, policies and procedures Support development and enhancement of compliance policies and SOPs related to AKS, FCA, and industry codes Qualification

Requirements JD required with 12+ years of relevant legal experience in the biopharmaceutical industry (biotech preferred) Deep knowledge of FDA promotional regulations, Anti-Kickback Statute, False Claims Act, OIG Guidance, and industry codes, and ability to stay current on evolving trends and enforcement 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 first US launch preferred) Strong business partnering skills with ability to balance risk and business goals Excellent communication skills Ability to manage multiple priorities in a fast-paced environment; comfortable working in a demanding start-up culture with evolving processes; flexible and able to adapt to new situations as the business demands \n The anticipated annual salary range for this job is based on prior experience in

the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual

bonus, in addition to competitive medical, dental, and vision

benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave

benefits. Other

perks include subsidized daily lunches and snacks at our on-site locations.

Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.

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