INTERIM PROJECT MANAGER, R&D; Pharmaceutical Development Reporting directly to the Chief Scientific Officer (CSO), the successful candidate will be responsible for managing and supervising the following activities: Provide comprehensive leadership, oversight, and execution support for a late-stage pharmaceutical development program entering FDA and EMA registration Define project scope, goals, deliverables, detailed project plans, schedules, budgets, and tracking tools; Manage project scope, risk, resources, budgets, and deliverables across multiple functions, monitoring progress and adjusting plans accordingly; Serve as the common point of contact linking internal and external scientific, operational, regulatory, and quality functions; Facilitate structured team meetings with clear agendas, action items, decision logs, and documented follow-up; Track progress of clinical operations activities (e.g., statistical analyses, CSR preparation) and review cycles for clinical documents (protocols, CSRs, SAPs); Collaborate with the Nonclinical team to manage timelines for study reports and the integration of data into Module 4 for the submission dossier; Coordinate with CMC and Analytical Development teams to track progress of formulation development, analytical method validation, stability programs, and Module 3 deliverables; Collaborate with Regulatory Affairs and external CRO(s) to track submission plans, regulatory strategies, briefing documents, and the compilation of Modules 1–5; Coordinate with Manufacturing and R&D; teams to track production campaigns, process validation, batch release,



and API/finished product facility inspections; Provide regular status updates, issue summaries, and materials for executive reviews, senior leadership, and Board-level updates. Ideal Profile Bachelor’s degree in Pharmacy, Pharmaceutical Chemistry and Technology, Chemistry, Biology, Biochemistry, or related disciplines (MS, Pharm D, Ph D, or MBA preferred); More than 5 years of project management experience in the pharmaceutical/biotech industry; solid knowledge of Gx P, ICH guidelines, and drug development pathways; Direct experience with registration-phase programs and FDA/EMA submissions (NDA/MAA) is highly preferred; Demonstrated ability to manage cross-functional teams, complex timelines, and global teams/CROs (PMP or equivalent certification is a plus); Strong leadership, facilitation, organizational, analytical, and problem-solving capabilities; Ability to work effectively in a dynamic, fast-paced, high-growth environment; Fluent English communication skills, both written and oral. Please note that this role is offered on a freelance/contract basis, and candidates must hold a valid VAT number. This job posting is open to female (F), male (M), and non-binary (NB) candidates, in compliance with Italian Law no. 300/1970, Legislative Decree no. 198/2006, and Legislative Decree no. 96/2026. We welcome applications from everyone, fully embracing diversity and inclusion. Please read the Randstad privacy policy in accordance with Art. 13 of the EU General Data Protection Regulation (GDPR) 2016/679. #J-18808-Ljbffr

📌 Project manager - bardi, emilia-romagna, italy
🏢 Randstad Professional Italia
📍 Bardi