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Interim Project Manager – R&D Pharmaceutical Development

Randstad Professional Italia · Milan

Libero professionista Senior 🇬🇧 English
GxP ICH guidelines

Job description

About the role

The Interim Management Division of Randstad Professional is seeking an experienced Interim Project Manager to lead a late‑stage pharmaceutical development program that is entering FDA and EMA registration. Reporting to the Chief Scientific Officer, you will coordinate cross‑functional teams to ensure timely delivery of regulatory dossiers and related deliverables.

Key responsibilities

  • Define project scope, goals, deliverables, schedules, budgets and tracking tools for a registration‑phase program.
  • Manage scope, risk, resources, budgets and deliverables across scientific, operational, regulatory and quality functions.
  • Serve as the central point of contact linking internal teams and external CROs, ensuring clear communication and documentation.
  • Facilitate structured team meetings with agendas, action items, decision logs and follow‑up.
  • Track clinical operations activities, non‑clinical study reports, CMC and analytical development progress, and integration of data into the submission dossier.
  • Coordinate regulatory affairs activities, submission plans and compilation of Modules 1‑5.
  • Provide regular status updates, issue summaries and materials for executive and Board‑level reviews.

Required profile

  • Bachelor’s degree in Pharmacy, Pharmaceutical Chemistry, Chemistry, Biology or related field (MS, PharmD, PhD or MBA preferred).
  • More than 5 years of project management experience in the pharmaceutical/biotech industry.
  • Proven experience with registration‑phase programs and FDA/EMA submissions (NDA/MAA).
  • Demonstrated ability to lead cross‑functional and global teams; PMP or equivalent certification is a plus.
  • Fluent English communication skills, both written and oral.

Required skills

  • GxP compliance
  • ICH guideline knowledge
  • FDA and EMA submission processes
  • Project Management (PMP certification preferred)

Questions fréquentes

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Le contrat proposé est un Libero professionista basé à Milan.

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Published 3 mesi fa

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Randstad Professional Italia

Milan