Senior Manager / Associate Director, Healthcare Compliance

4 hours, 43 minutes ago
Full-time
Senior
Operations
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

Description

  • Assist in the development, implementation, and maintenance of the company’s healthcare compliance program.
  • Develop policies and procedures that guide employee conduct and compliance practices.
  • Lead compliance training programs for employees at all levels.
  • Conduct compliance audits, monitoring, and risk assessments to identify vulnerabilities and exposure.
  • Support federal and state transparency and aggregate spend reporting requirements.
  • Manage the company’s whistleblower hotline and related intake processes.
  • Partner with legal, regulatory, and operational teams on compliance guidance for new initiatives and projects.
  • Investigate compliance issues and coordinate corrective actions with relevant stakeholders.
  • Stay current on industry trends, regulatory changes, and compliance best practices.
  • Support future field engagements and commercial/promotional compliance activities following potential product approval.

Requirements

  • Bachelor’s degree in life sciences, law, business, or a related field; advanced degree such as a JD or MBA is preferred.
  • Minimum of 6 years of experience in compliance, regulatory affairs, or a related field within the pharmaceutical or biotech industry.
  • Strong knowledge of FDA regulations, GxP standards, and other relevant compliance frameworks.
  • Ability to interpret and apply complex regulations and guidelines to business practices.
  • Experience handling marketing and promotion matters for pharmaceutical products.
  • Excellent analytical and problem-solving skills.
  • Strong business judgment in healthcare compliance and risk management.
  • Ability to work effectively in cross-functional teams with a collaborative, hands-on approach.
  • Ability to manage multiple tasks independently and simultaneously.

Benefits

  • $150,000 - $200,000 annual salary range.
  • Pre-IPO equity.
  • Annual bonus opportunity.
  • Competitive medical, dental, and vision benefits.
  • PTO.
  • 401(k) plan.
  • Life and accidental death and disability coverage.
  • Parental leave benefits.
  • 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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