Medical Compliance Manager
The Cystic Fibrosis Foundation (CFF) and its employees embrace their commitment to its core values. These core values are the pillars on which CFF stand and will continue to sustain us as we move forward.
- Keep sight of what really matters: Our decisions are based on what is best for people with cystic fibrosis and their families.
- Aspire for excellence in all we do: We take pride in our work. We are committed to continuous learning and improvement.
- Stronger together: We collaborate and work together so that we can learn more and achieve more.
- Innovate with courage: We embrace challenges. We reach beyond boundaries in pursuit of our vision.
- Care about our people: We deeply care about each other and all who support our shared mission. We listen with respect. We support one another.
POSITION SUMMARY:
The Medical Compliance Manager works as part of a team and, under direction, is responsible for: 1) working with scientific program officers to draft, negotiate, and track the status of Material Transfer Agreements (MTAs) and licensing/intellectual property issues and 2) provides assistance to the Medical Compliance team with issues related to compliance with Federal research regulations and HIPAA. Reporting to the Director of Medical Compliance, the Medical Compliance Manager serves as the primary point of contact and knowledgeable resource for the Medical Department, including the Research Affairs team, Therapeutics Development team, and Clinical Affairs team, to assist with issues related to technology transfer and licensing agreements as well as industry and academic research. The Medical Compliance Manager will also be responsible for working with the Senior Director of Medical Compliance to manage and coordinate organization-wide HIPAA compliance and remediation efforts.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Reviews and negotiates MTAs and develops and builds relationships with external parties needing MTAs with CFF.
- With CFF counsel, tracks technology transfer, licensing, and intellectual property matters.
- Utlizes CFF databases to track, develop, or amend terms and conditions of MTAs and to generate reports in order to keep CFF staff informed.
- Tracks patents related to CFF-funded research and development programs.
- Works with Senior Director of Medical Compliance to maintain HIPAA compliance efforts.
- Works with others in the Medical Department to identify and correct privacy and confidentiality issues.
- Works with Senior Director of Medical Compliance to ensure compliance with federal human subjects research regulations.
- Coordinates remediation efforts for various security and risk assessments in the Foundation, with the rest of the Medical Compliance team members.
- Manages, with the Senior Director of Medical Compliance, compliance efforts at the Cystic Fibrosis Foundation Therapeutics Lab.
- Regularly communicates Medical Department’s compliance needs to senior leadership, including Senior Vice Presidents of Research Affairs, Therapeutics Development, and Clinical Affairs.
- Other duties as assigned.
KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:
- Bachelors degree required (JD preferred).
- Relevant experience negotiating standard contract terms.
- 4-5 years of experience working with research and HIPAA compliance.
- 1-2 years of experience working in technology transfer office at a university or research institute, or alternatively in an industry environment, preferred.
- CIPP or CIPM preferred.
- Understanding of basic contract principles and contract terms.
- Ability to communicate effectively in person, on the phone, and in writing with external parties and internal staff at all levels having varying degrees of understanding of the relevant regulations and procedures.
- Strong computer skills, including the use of Microsoft Office Suite.
- Knowledgeable of applicable laws and regulations, including those related to HIPAA, research, and privacy, and able to apply them to daily work processes.
- Ability to spot issues quickly and articulate in a thoughtful and responsive way to not only raise awareness but also provide possible solutions.
- Ability to track and organize a large number of material transfer agreements with differing templates and purposes.
- Fluency in intellectual property issues preferred.
- Comfort and confidence in managing a small team.