Integration and Regulatory Program Manager in Pharma

Following a multi-billion-dollar acquisition, the R&D organization of an F100 pharma company initiated seven integration sub-teams, each of which were critical to business continuity during the integration period. They reached out to Business Talent Group (BTG) for a senior program manager to provide overall program management support and lead the Inspection Readiness workstream.

BTG provided a former Gemini Consulting Practice Lead with expertise in post-merger integrations for quality and compliance systems. The consultant supported the client by leading and supporting a number of initiatives, including accessing source data and documents, populating Inspection Readiness templates, and quality checking transcribed data (trial Masterfile links, Crispifications, Sunshine reporting, end of study reporting, and QA record movement) to ensure cohesiveness during the integration period.