by Ashley Schmitz | Sep 2, 2024
For a new medical device company, we defined and executed both Regulatory and Marketing Strategies. We clarified US and European regulatory requirements and timelines and established the company’s Quality Management System, including numerous processes and...
by Ashley Schmitz | Sep 2, 2024
For a major Japanese pharmaceutical company, we worked with the Chief Medical Officer, global functional executive leaders, Human Resources and Finance to implement the organizational redesign of five medical groups encompassing 2,550 medical professionals in 35...
by Rich Cruz | Sep 2, 2024
For a Fortune 250 vaccine developer, we worked with the Project Management Office to identify and deconflict multiple overlapping governance models across several organization-wide strategic initiatives. We outlined opportunities to harmonize governance structures to...
by Ashley Schmitz | Sep 2, 2024
For a Fortune 100 pharmaceutical company, we worked with Project Management Office (PMO) leadership to manage nine workstreams focused on reorganizing the company’s clinical development capabilities into a global function. Sample workstreams include R&D,...
by Rich Cruz | Feb 5, 2024
In response to the COVID-19 pandemic, a 501(c)3 charitable organization faced the immediate challenge of transitioning to a remote work model to safeguard the health of its employees while ensuring the continuity of its services. This case study details the...
