Orca

Senior Manager / Associate Director, Compliance

Orca

full-time

Posted on:

Location Type: Remote

Location: California • United States

Visit company website

Explore more

✨ AI Apply
Apply

Salary

💰 $150,000 - $200,000 per year

Job Level

Senior

About the role

  • Support the development and execution of a healthcare compliance program.
  • Report to the SVP/Head of Legal.
  • Work cross-functionally to lead key elements of a pre-commercial compliance program—including policy and SOP development, transparency and aggregate spend reporting, training, and commercial and promotional compliance review.
  • Support future field engagements following potential product approval.
  • Conduct regular compliance audits, monitoring and risk assessments to identify potential areas of compliance vulnerability and risk.
  • Assist in the completion of activities related to federal and relevant state transparency-driven compliance requirements.
  • Manage the Company’s whistleblower hotline.
  • Collaborate with legal, regulatory, and operational teams to provide compliance guidance and support for new initiatives and projects.
  • Investigate compliance-related issues and coordinate with relevant stakeholders to ensure appropriate corrective actions are taken.
  • Stay current with industry trends, regulatory changes, and best practices in compliance.
  • Engage in such other activities as directed by the Senior Vice President, Legal.

Requirements

  • Bachelor’s degree in life sciences, law, business, or a related field; advanced degree (e.g., JD, MBA) 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.
  • Proven ability to interpret and apply complex regulations and guidelines to business practices.
  • Excellent analytical, problem-solving skills.
  • Well-rounded, experienced compliance expert who has played a key role on matters relating to the marketing and promotion of pharmaceutical products and possesses excellent business judgment concerning overall healthcare compliance and risk management.
  • Ability to work effectively in cross-functional teams with a collaborative and hands-on approach.
  • Ability to manage multiple tasks independently and simultaneously.
Benefits
  • 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 our on-site locations
  • Pre-IPO equity
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
compliance program developmentpolicy developmentSOP developmenttransparency reportingcompliance auditsrisk assessmentsFDA regulationsGxP standardsregulatory affairsbusiness judgment
Soft Skills
analytical skillsproblem-solving skillscollaborative approachindependent task managementcross-functional teamworkcommunication skillsleadershipattention to detailadaptabilityinterpersonal skills
Certifications
Bachelor’s degreeJDMBAcompliance certificationregulatory affairs certificationGxP certificationhealthcare compliance certificationrisk management certificationinternal audit certificationcertified compliance and ethics professional