“We are focused on results. Those that can be measured. And those measured in ways beyond numbers. We see individuals, not issues. We are inspired by passion, and compassion for the wellbeing of people. Our methods are based on logic, driven by rigor, results, issues, and outcomes. Our innovation means trying new things, learning from our mistakes, and consistently refining our approach. Our strategies help us define our path to success, but our effectiveness is based in the aggregate power of our initiatives to impact holistic change.”

-Bill Gates and Melinda French-Gates

The Bill & Melinda Gates Medical Research Institute (Gates MRI) is a non-profit biopharmaceutical development organization primarily dedicated to the development of impactful biopharmaceutical interventions for diseases that disproportionately affect the world’s poorest populations, diseases that combined cause five deaths every minute. Headquartered in Cambridge MA, the Institute is designed to advance novel drug, biologics, and vaccine candidates through late-stage development and registration. The Institute encompasses experienced biopharmaceutical development professionals across regulatory, CMC, and clinical functions as well as comprehensive operational support functions. The Institute’s programs are managed by its internal teams and functional areas in collaboration, working with partners across the global health ecosystem.

The Institute is based on five core “mantras” that are embedded within the organization and its people:

• Urgency : Execute with excellence to maximize impact.

• Collaboration : Establish empowered teams to drive our bottom line: lives saved.

• Innovation : Build on the known, uncover the new, achieve the unprecedented.

• Rigor: Drive the science, focus on the details, and execute with the highest quality.

• Courage : Dare to confront the world’s most significant global health challenges.

Though the Institute is a diverse group of passionate change-makers, creative fixers, and relentless advocates, these five core values are universally adopted by all who join it with the personal goal of improving the health and wellness of the world’s most vulnerable populations.

As a wholly owned subsidiary and separate legal entity of the Bill & Melinda Gates Foundation, the Institute partners scientifically, operationally, and financially with the foundation to leverage the foundation’s ongoing support and contributions toward the achievement of global health equity.

The Institute is currently composed of 160 employees and leverages dedicated vendor partnerships and consultant staff to assure the right skills are in place at the right time while retaining the flexibility to adapt as required by the development program portfolio.

The Gates MRI offers hybrid work arrangements, a 50% mix of on-site and work-from-home, and a competitive relocation package for those looking to move to the Cambridge, MA area. Remote employment is not offered for this role at this time.

THE POSITION

Reporting to the Head of Compliance and Risk Management, the Compliance and Risk Management Operations Associate Lead will be responsible for providing operational support to ensure the successful design, development, implementation of Institute’s Compliance and Risk Management (C&RM) Ethics and Integrity Program in full compliance of with applicable national and international laws.

You will leverage your project management skills in support the different elements that comprise the Ethics and Integrity Program, such as: assisting in the development, drafting and implementation of corporate policies, standard operating procedures and industry best practices; the creation and delivery of effective training, assisting the conduct of internal monitoring, after action reviews and audits in accordance with the Executive Leadership endorsed annual Operational Master Audit Plan and ensuring corrective measures are followed up and put into effect.

You will be highly knowledgeable with regards to compliance procedures, policies, standards, and obligations with solid experience of helping to develop and manage corporate compliance programs and providing compliance guidance and oversight.

Core Responsibilities

• Assist in developing, drafting, implementing, and maintaining corporate policies, standard operating procedures, and industry best practices.

• Create compliance training materials and deliver effective training to internal stakeholders.

• Prepare updates to the Corporate and Operational Risk Registers through cross-functional collaboration (e.g., meetings/interviews of key shareholders).

• Assist the conduct of internal monitoring, after action reviews and audits including stakeholder interviews, data collection and analysis and ensure corrective measures are followed up and put into effect in accordance with required timelines.

• Project Mangement to create and circulate formal agendas, draft meeting minute, track action items, for C&RM led committees such as the Ethics Integrity & Risk Committee, Operational Sub-Committee and Data Privacy Committee.

• Contribute to internal communications to build out and maintain the Compliance Corner SharePoint page to facilitate employee engagement, understanding, and access to resources relevant for the C&RM function.

• Work with outside counsel to perform debarment and exclusion checks.

• Assist the collection and analysis of data to be included in the quarterly Compliance Metrics dashboard/report to the CEO and leadership team.

• Support C&RM’s data privacy program (e.g. Help prepare data privacy impact assessments (DPIAs) with external legal counsel’s input)

• Research and analyze regulatory trends, new legislation, etc.

• Such other tasks and projects as may be assigned from time to time

QUALIFICATIONS

• Batchelor’s degree in a compliance related field such as finance or business administration.

• 7 years of experience helping to develop and manage corporate compliance programs and providing compliance guidance and oversight gained within the highly regulated pharmaceutical product research and development environment. (i.e. Biotech/Pharma experience required)

• Proficiency at defining legal and industry standards via corporate policies, and standard operating procedures, creating and implementing training, assisting in the conduct of audits, after action review and monitoring.

• Strong organizational skills.

• Strong interest in life sciences, and global public health.

• Demonstrated commitment to working with the highest level of integrity and ethics.

• Ability to exercise good judgment and discretion when working on confidential/sensitive projects and issues.

In recognition of high-wage market differences such as the Cambridge, MA area where this position is located, the salary range for this role is $140,000 to $175,000 USD. As a mission-driven organization, we strive to balance competitive pay with our mission. New hires salaries are typically between the range minimum and the salary range midpoint. Actual placement in the range will depend on a candidate’s job-related skills, experience, and expertise, as evaluated during the interview process.

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Hiring Requirements

As part of our standard hiring process for new employees, employment will be contingent upon successful completion of a background check.

Candidate Accommodations

If you require assistance due to a disability in the application or recruitment process, please submit a request here.

Inclusion Statement

We are dedicated to the belief that all lives have equal value. We’re committed to creating a workplace where employees thrive both personally and professionally. We also believe our employees should reflect the rich diversity of the global populations we aim to serve—in race, gender, age, cultures and beliefs—and we support this diversity through all of our employment practices.

All applicants and employees who are drawn to serve our mission will enjoy equality of opportunity and fair treatment without regard to race, color, age, religion, pregnancy, sex, sexual orientation, disability, gender identity, gender expression, national origin, genetic information, veteran status, marital status, and prior protected activity.