Project Manager
4 days ago
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 POSITIONThis 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.RESPONSIBILITIESManage 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 & REQUIREMENTSMS 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 todayPlease be informed that only selected candidates will be contacted.
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