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Job Title: Project ManagerDivision - IPDDepartmentSub Department 1Job PurposePlan, monitor and execute IPD projects within budget and time to secure the launches as per the business needKey Accountabilities (1/6)Drive successful product approval by developing product development strategy and a detailed work plan to ensure successful project delivery within the laid down parameters of time and cost- Create detailed Project development plan, Timeline, cost, milestones, critical path along with resource allocation in line with business requirement - Communicate and align project team members in line with project plan on timelines, resources - Manage license activities in coordination with regulatory team - Manage and de-bottleneck logistic issues for availability of API, Innovator, Raw materials, test samples etc. as an when required to ensure smooth execution - Ensure on time execution of feasibility/Assessment/regulatory /DMF batches, bio studies, filing by conducting periodic review meetings with unitsKey Accountabilities (2/6)Mitigate risks proactively by monitoring project progress against identified risks, tracking deliverables, reviewing milestones and providing feedback and information to the Project team to ensure timely execution- Lead project stage gate meetings to review milestones, actual costs, provide weekly project status and escalate issues for deviation of scope - Manage conflict and bring quick resolution to difficult problems through timely intervention and by facilitating and strengthening the interaction between CFTs - Track and drive regulatory and quality compliance requirements, deviation and change controls - Lead project risk mitigation workshop to identify risks involved to projects, prepare mitigation plan and ensure execution of the sameKey Accountabilities (3/6)Drive effective project communication to ensure sound decision by doing cross functional project team meeting and sharing consistent information across stakeholders- Ensure timely analysis and reporting to enable accurate information sharing - Lead project meeting with CFT member for project key decisionKey Accountabilities (4/6)Build relationship with Business team, portfolio and external customer by sharing project progress, doing project review meetings- Sharing monthly project status reports to BD and Portfolio - Share SOW, team sheet with legal, Business, Quality and CMO teamKey Accountabilities (5/6)Ensure continuous improvement of internal processes and project execution by monitoring progress- Ensure compliance to the operational excellence initiatives like 6 month planner for manufacturing batches in unit - Managing adherence to stage gate process - Provide detailed Project handover document to the corporate project managers post filing to ensure seamless integration - Provide lessons learned during deficiency response, launch review meetings post filing to CFTsKey Accountabilities (6/6)Major Challenges- Non-adherence of task timeline by different stakeholders of projects which leads to delay in execution. Overcome by Periodic review, Multiple project meetings to ensure progress of the task towards completion - Change in Project scope during development stage which leads to delay in filing and launch of project. Overcome by escalation to HODs/Portfolio/Business teamKey Interactions (1/2)Internal- Analytical for analytical activities (Daily) - Regulatory for regulatory checks (Daily) - API/Procurement for material (Daily) - Quality to release document & material (Weekly) - Manufacturing & Quality for execution of Batches (weekly/need based) - IP (weekly/Need based) - Formulation/API R&D teams (Daily) - Portfolio/ Business (Need based) - Manufacturing Unit Heads (Need based) - Finance (Need based) - Clinical (Weekly/Daily)Key Interactions (2/2)External- CMO for manufacturing facility (Monthly) - Vendors for materials, Devices etc. (Weekly) - CRO (Need based)Dimensions (1/2)Geographies: GlobalNo of projects: 15-25 nosDimensions (2/2)Key Decisions (1/2)RecommendationsBased on the quality issue of the vendor, proposal to drop the projectKey Decisions (2/2)Education QualificationB. Pharm/M. Pharm/ MSc preferably PMP certifiedRelevant Work Experience7-8 years in the field of product development and/ or project management in Pharmaceutical industry