Led healthcare compliance buildout for industry leader
"I had the privilege of working closely with Mary for several years at a prior role in big pharma. Mary gets it done. She works relentlessly to build effective, sensible, defensible, concise solutions to complicated problems, often creating policies and processes from scratch, ahead of the curve. She builds consensus with good humor, energy, vision, enthusiasm, and clarity. She gets the big picture, and sweats the tiny, critical details.
Mary is a true professional, and one of the most outstanding compliance experts I have come across in 22 years in-house. I recommend her with the highest endorsement."
Sean Martin, Chief Legal Officer & General Counsel, Generate Biomedicines
Challenge
The PhRMA Code and OIG Compliance Guidance signaled increased enforcement and called for industry change. Before they were issued, many in house attorneys managed risk by reviewing routine transactions. The lawyers needed to be involved earlier and more strategically.
Solutions
As an engineer, I recognized the need for better processes. I began developing simple, clear policies to guide business partners for the easy issues. I also started educating both lawyers and internal clients on how less lawyer review would actually help us to better manage risk by freeing up the lawyers to engage on higher impact activities.
A year later, our General Counsel tasked me with launching Amgen’s compliance and business ethics program.
Drawing upon my Big Consulting experience, I collaborated with business partners who understood the company’s existing systems to translate legal requirements into process improvements that would help the company meet rapidly changing government expectations.
Over the next two years, my cross-functional team:
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Rolled out the program and training to the entire commercial and medical affairs organizations and drove uptake at the grassroots level
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Worked across the organization to design and implement key processes, systems and controls
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Instituted a continuous improvement culture to grow our nascent program to include other key risk areas and activities
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Developed monitoring and audit programs, and helped investigators design a framework to manage new issues that began to surface
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Answered a mountain of questions
Results
Following our simple, but impactful start, we proved the case for compliance and obtained the funding needed to develop our early system into the mature program it is today.