WHAT YOU’LL BE DOING:

Inspire, the online health community that supports millions of patients and caregivers, advances understanding of the health journey, and partners with the biopharmaceutical community to provide patient access and real-world evidence solutions. Inspire is seeking a Compliance Specialist to help lead our compliance program by championing quality and overseeing compliance in accordance with a Quality Management System (QMS) that delivers uniform standards and controls for technical development, people training, data management, and project delivery. This role will develop, manage, maintain, and advance policies, procedures, plans, templates and forms related to compliance. This role will also be responsible for managing all audits.

In this role you will: 

• Maintain annual compliance calendar and schedule:
  • Necessary audit events (internal, vendor and client)
  • Documentation reviews
  • Assessments (risk and vendor)
  • Revisions to standing policies
  • Certifications (e.g., SOC2)
• Host audits and manage findings and oversee remediation, if necessary
• Maintain logs and matrices:
  • CAPA
  • Approved Subcontractor List (ASL)
  • Data requests
  • Training records
• Manage QMS including HIPPA, CCPA, GDPR, 21 CFR Part 11, GxP, SOC, ISO, etc
• Communicates with sponsor(s) audit/quality organizations and teams
• Support overall organizational development of SOPs and regulatory standards

WHAT WE NEED:

We are searching for a resourceful team player who is passionate about our mission, eager to learn, and ready to make a tangible impact.

• 4 years of clinical trial experience and 6 years of compliance experience, or equivalent
• Knowledge -Proven understanding of Clinical Research Organization (CRO) and Pharmaceutical quality organizations’ expectations and requirements.
• Technical – Practical application of quality controls in clinical research (Phase I-IV studies)
• Business – Strong business understanding is essential to align product strategies with overall business objectives.
• Leadership – Be an effective leader capable of inspiring and motivating teams, set a clear vision, foster collaboration, and empower their team members to achieve their full potential.
• Communication – Excellent communication skills to convey complex ideas, assess risk and build constructive remediation plans for issues and preventative action plans for risks
• Entrepreneurial and adaptable – Adaptability and flexibility to changing priorities, and demonstrated ability to work creatively and effectively in a fast-paced environment
• Organizational – Attention to detail and ability to work simultaneously on multiple projects. An entrepreneurial spirit and drive.

WHAT WE VALUE:

• Resourcefulness and team collaboration 
• Demonstrated ability to work creatively and effectively in a fast-paced environment
• Passionate about the intersection of health and technology 
• Strong empathy for members and passion for growth
• Collaboration – an ability to establish and maintain effective working relationships with coworkers, managers and clients

BENEFITS:

• Competitive salary and benefits
• Generous Flexible Time Off policy
• Stock options
• Health insurance, including dental and vision
• 401(k) retirement plan with matching
• Ability to work anywhere in the US