Regulatory Submission Process Transformation Project Manager

Our client, a global biotechnology company, are looking for a Project Manager to manage an end to end (E2E) Regulatory Submission Process Transformation project. The role is a contract inside IR35 until the 31^st December (ideal start date is mid-April).

Project Manager Responsibilities:

• Act as Project Manager for the End-to-end (E2E) Regulatory Submission Process Transformation project, a cross-functional continuous improvement (CI) project sponsored and led by Global Regulatory CMC; highly visible, top 5 CI project for PO&T in 2021
• Establish and lead standing forum with E2E Project Leads to track progress, surface risks and mitigations, and proactively identify decisions and/ or endorsements needed for all sub-projects within E2E project.
• Provide regular status reporting/ updates to E2E Lead and governance as appropriate, including project status, accomplishments, risks, and upcoming decisions/ endorsements.
• Project Management support of complex E2E projects, working directly with Project Leads.
• Maintain clear knowledge management structures for E2E documents to ensure relevant information is captured and available when and where it’s needed.
• Support E2E Lead at governance forums – including meeting scheduling, coordinating presenters, meeting minutes, and follow-up on action.
• Collect, synthesize, and analyze project progress including risks and opportunities; provide regular status updates via dashboards to E2E Lead, project teams, and governance.

The contract is based in Maidenhead (remote to start) and is initially 7 months+.

Project Manager Requirements:

• Relevant experience with E2E regulatory submissions
• Strong knowledge of Project Management best practices, tools, and techniques
• Strong organizational skills; ability to manage complexity and multiple concurrent priorities
• Excellent client-facing and internal communication skills
• Team-oriented; proactively builds healthy working relationships with Project Leads and drives community of practice
• Ability to utilize systems to gather data, organize/interpret, and generate reports
• Excellent written and verbal communication skills
• Strong working knowledge of Microsoft Office
• Skills in Sharepoint a plus
• Working understanding of continuous improvement concepts a plus

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