Project Manager
il y a 5 jours
Bilbao
At Adalvo, we're not just a company - we're a team of passionate people driven by our mission to consistently deliver high-quality products and services to our partners. We are positive, we are fast, we are always on target, we are Adalvo! 🎯 🚀 We are looking for an enthusiastic Project Manager to join our dynamic Adalvo team. This position offers an opportunity to well-suited candidates to join a growing, fast paced energetic environment and culture. SUMMARY OF POSITION This role involves independently managing and coordinating pharmaceutical development projects, ensuring alignment of timelines, budgets, and deliverables across cross-functional teams and external partners. It requires proactive risk management, effective stakeholder communication, and strong organizational skills to drive project execution, reporting, and decision-making within a complex, regulated environment. RESPONSIBILITIES • Manage and coordinate projects, tasks, schedules, status and project reporting to stakeholders independently., • Facilitate communication within and outside the project team., • Facilitate problem-solving & decision-making with respect to project deliverables and meeting timelines/tasks/requests from project teams and other cross-functional departments., • Follows up with team members to ensure timely deliverables (e.g., major milestones, cost and scope), • Focus on proactive planning to manage risk, remove barriers and meet goals., • Establish project plan baselines and document assumptions., • Fully understand business cases including competitive landscape, regulatory/clinical requirements, IP landscape and other potential external factors which may derail the project., • Prepare draft agendas, meeting minutes, presentations for project related meetings to varied stakeholders, including governance boards., • May organize and participate in partner meetings as they relate to the position., • Review relevant project specific documents., • Management of Reference Drug procurement and shipment - Compiles and monitor completion of key development tasks through milestone completion, quality gates, and stage gating processes., • Identify trends among common projects., • Identify project budget risks and opportunities, describe the impact and adjust the budget to create acceleration opportunities for important milestones., • Manage and reports project budget, contract milestones and spend according to established financial cycles. shall be involved in 5YP budget preparation, 3+9, 6+6 and 9+3 forecast preparation., • Ready to travel to different CMDO/CMO/CPO across different geographies as per organizational need. QUALIFICATIONS & REQUIREMENTS • MS in pharmaceutical science, chemical engineering, or equivalent scientific discipline. MBA is an asset., • At least 10 years of experience in Project Management with a track record of successfully managing pharmaceutical products from development through highly regulated registration stages to successful launches and commercialization., • Should have thorough understanding of generic drug development cycle including 505(B2) and complex generics and various regulatory guidelines, (ICH, ANVISA, USFDA, EMA) and regulations (GMP, GCP, GLP etc.), • Should have thorough understanding of eCTD dossier modules and various regulatory filing pathways for EU, US, CA, PMDA, LATAM etc., • Should have knowledge of EPM / MSP software and expert in Microsoft excel and power point presentations., • Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and build relationships with key stakeholders., • Demonstrated ability to work in a fast-paced, dynamic environment with a sense of urgency and the ability to prioritize effectively. Why join us? 🎯 Exciting Challenges: Every day brings new opportunities to learn and grow. 🎯 Supportive Environment: We foster a culture of collaboration, where your ideas are valued, and your voice is heard. 🎯Career Development: We're committed to helping you reach your full potential through ongoing training and development opportunities. 🎯Recognizing Excellence: We recognize and appreciate hard work and dedication by offering competitive compensation packages and employee rewards programs that acknowledge contributions and achievements. 🎯Fun and Inclusive Culture: We believe in celebrating our successes and building strong connections within our team. Ready to Ignite Your Passion? If you're ready to take the next step in your career and join a business committed to consistently deliver high-quality products and services, then we want to hear from you! Send us your resume today! Please be informed that only selected candidates will be contacted.
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