Job Summary We are seeking a dynamic and experienced Project Manager in Research & Development team for comprehensive project management support throughout the project lifecycle, including initiation, planning, execution, monitoring, and successful filing or project launch with all regulatory requirements and launches as per business and market requirements. Responsibilities also include creating and maintaining detailed project information, ensuring effective coordination between cross-functional teams (CFTs), facilitating smooth workflow, and ensuring seamless communication. Regular and accurate status reporting is essential, along with serving as the single point of contact (SPOC) for external partners and vendors for third-party assignments. Roles & Responsibilities You will be responsible to collaborate with stakeholders to draw up a comprehensive project plan and establish clear timelines for each milestone. Organize project kick-off meetings and ensure adherence to the Design and Start of Development (DSN) phase gate protocols in coordination with the Quality Assurance (QA) team. You will be responsible to develop the Project Development Charter (PDC) in collaboration with the Portfolio team, incorporating the project's overall budget allocation for each year. You will be responsible for project planning & scheduling for timeline tracking and alignment with stakeholders. Interaction with cross functional team for task monitoring, ensuring the licenses availability for all markets, availability of raw material for development, assisting the team for readiness for pilot studies and go -to-plant readiness. You will be responsible for identifying issues for de-bottlenecking. Coordination for Pre-clinical and clinical/regulatory strategy finalisation for differing markets to ensure timely product development for scale-up and registration/Exhibit batches leading to filing and launch. You will be responsible to ensure timely project updates via MIS reports and regular presentations to senior management, facilitating task completion for timely milestone achievement. Implement project schedule optimization and risk management strategies, while effectively managing budgets and prioritizing activities for seamless project progression. You will be responsible for project monitoring and control by ensuring effective risk identification and debottlenecking, prioritize activities as needed, and promptly address and resolve issues by engaging the relevant teams, including budget enhancement and execution area allocation. You will be responsible to monitor costs against deliverables, resolve conflicts, manage changes during the project lifecycle, and make key decisions based on evolving business scenarios. You will be responsible to facilitate urgency for priority project delivery, oversee coordination with external manufacturing partners, and provide support to Regulatory Affairs (RA) for document tracking and filing. Additionally, ensure timely closure of Quality Assurance (QA) and Quality Control (QC) issues, dossier filing. You will be responsible to facilitate post-filing activities, including additional batch planning, sample preparation for studies, and document preparation, while ensuring effective coordination for a successful product launch and maintain adequate stock levels at the Global Distribution Centre to meet business and market needs.
Educational qualification: Masters in Pharmacy/ MBA Minimum work experience: 5 years of experience preferably in Project Management Organisation or formulation development for different markets Skills & attributes: Technical Skills Broad understanding of pharmaceutical requirements for different geographies (US, China, Russia, India, Brazil). Certification in Project Management/Training in Project Management. Experience in MS projects/any other project planning software. Behavioural Skills Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities.
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