About Us:
At Vault, we believe quality healthcare is a human right. Our mission is to make better health outcomes more accessible and affordable for everyone. Our platform makes this possible by bringing remote diagnostics and specialty care to patients in their homes, on their home screens, and within their hometown communities— wherever they choose. We are reimagining the 21st century healthcare experience for patients, practitioners and providers—making the promise of better health more attainable through our end-to-end healthcare platform.

The Opportunity:
We are currently hiring a Compliance Lead, Life Sciences, reporting to the Chief Compliance Officer as part of Vault’s Legal Department. This role will support a growing global clinical trials business, as it builds from providing support to clinical trial sites in the US trial support into higher-touch areas, such as government-sponsored research and overseas research.  He/she will work closely with the Head of Quality Assurance within Life Sciences. This role is responsible for providing compliance and ethics  advice to the Life Sciences team and ensuring the team operates in accordance with legal parameters. This role will work closely with  he Associate General Counsel, Life Sciences  to establish policies, operational practices, controls, and enforcement to ensure compliance with applicable laws and regulations. This person will also assist in conducting internal audits and responding to third-party requests, including regulatory inquiries, vendor audits, and requests for proposals.  The ideal candidate is a self-starter, comfortable making decisions on a short timeframe and autonomously, and has broad experience in clinical trial support.  

Qualifications: 

  • 6+ years experience, including at least three in-house in the compliance function of a pharmaceutical, biotechnology, medical device company, or a CRO.
  • Experience reviewing Clinical Trial Agreements for, or on behalf of, a life sciences organization, involving industry sponsors, CROs/SMOs, government agencies, universities and other large healthcare companies.
  • Experience reviewing collaboration agreements, informed consent forms, and agreements for confidentiality, regulatory, consulting, supply, investigator initiated/sponsored studies, CRO/SMO contracting, research, and other related clinical trial agreements.
  • Experience in compliance program strategy and transformational initiatives between business units and corporate risk and compliance functions is strongly preferred.
  • Solid understanding of industry standards for ethics and compliance risk within the Life Sciences industry.
  • Knowledge of life science processes, controls, and regulatory requirements in core areas (e.g., FDA Regulations and Guidance, False Claims Act, ICH Guidelines, rules governing IRBs and GCPs, anti-bribery and corruption, transparency reporting).
  • Must have exceptional relationship building skills, must be a team player, and have a strong sense of urgency.
  • Must have strong verbal and written communication skills.
  • Experience in program and/or project management for technology implementations using top analyst rated third party software a strong plus.
  • Working knowledge of technology solutions such as Tableau or ZenGRC a strong plus.
  • JD preferred but not required.

Vault Health is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, national origin, age, disability, or veteran status.

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