
Project Management Specialist
2 days ago
We are seeking a skilled Project Management Specialist to oversee the successful execution of complex projects from initiation to delivery. This role requires strong organizational and leadership skills, with the ability to motivate cross-functional teams and drive project goals forward.
Job Description:
- Manage and coordinate project activities, tasks, schedules, status, and reporting to stakeholders independently.
- Facilitate communication within and outside the project team.
- Facilitate problem-solving and decision-making with respect to project deliverables and meeting timelines/tasks/requests from project teams and other cross-functional departments.
- Follow 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 that 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 monitors 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.
Required Skills and Qualifications:
- Qualification: M. Pharmacy or B. Pharmacy with MBA.
- Experience: At least 9 years of experience in Project Management with prior experience in Formulation Development of solid oral dosage forms, Parenteral dosage form, Liquid dosage form, Topical dosage form, Nasal spray (Protein and Peptide Delivery System/Complex Parenteral Dosage forms will be added advantage)
- Should have thorough knowledge of generic drug development cycle, including 505(B2), complex generics, peptides, 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 PowerPoint presentations.
Benefits:
- Dynamic work environment
- Self-driven culture
- Capable to work in a highly entrepreneurial environment
- Result-oriented approach
- Practical mindset
Others:
- Exciting challenges every day
- Supportive environment where your ideas are valued, and your voice is heard
- Career development through ongoing training and development opportunities
- Recognizing excellence through competitive compensation packages and employee rewards programs
- Inclusive culture that celebrates successes and builds strong connections within the team
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