#R-224136
nt forums. They continuously improve the M&A/I operating model, processes, and templates.
Roles & Responsibilities:
Act as the Project Manager for high-priority initiatives
Develop business cases for initiatives that capture costs, benefits, and overall value that is intended to be delivered
Develop initiative charter
Establish governance that includes key leaders of impacted populations
Establish initiative scope, objectives, value realization measures, and targets
Track, review, and regulate the progress and performance of the initiative
Measure, track, and monitor value realization
Provide change management support
Support teams with the use of transformation tools and methodology
Mergers, Acquisitions & Licensing Integrations (M&A/I) - Regulatory Focus
Lead Regulatory workstreams across all deal phases and own deliverables
Serve as POC/SME. Maintain operating playbook and QMS bridging documents, manage risks/dependencies, represent Regulatory in integration forums.
Perform Regulatory due diligence, synthesize findings and recommendations for senior leaders.
Execute change management to enable effective implementation and adoption.
Required Knowledge & Experience:
Project Management
Business strategy consulting experience and Business case development
Change Management, including developing Sponsorship for changes, engaging impacted populations, change communications, and behavior change
Expertise with business transformation initiatives and programs
Excellent written/oral communication skills and attention to detail
Must demonstrate strong leadership skills in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment
Preferred Qualifications & Experience:
Prior experience supporting or leading M&A/I integrations within pharma/biotech domains preferred.
Ability to anticipate and address integration risks.
Additional certifications (e.g., PMP, Prosci/ACMP (change), Lean/Six Sigma), MBA is a plus.
Strong knowledge of the drug development and commercialization cycle, including submissions and health authority interactions.
Proficiency with Microsoft Office, Smartsheet, and SharePoint.
Basic Education and Experience:
Master's degree and 9+ years of overall experience
OR
Bachelor's degree and 11+ years of related experience
AND
4-6 years of relevant experience.
.