Job Title: Project Manager
Division - IPD
Department
Sub Department 1
Job Purpose
Plan, monitor and execute IPD projects within budget and time to secure the launches as per the business need
Key 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 units
Key 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 same
Key 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 decision
Key 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 team
Key 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 CFTs
Key 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 team
Key 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: Global
No of projects: 15-25 nos
Dimensions (2/2)
Key Decisions (1/2)
Recommendations
Based on the quality issue of the vendor, proposal to drop the project
Key Decisions (2/2)
Education Qualification
B. Pharm/M. Pharm/ MSc preferably PMP certified
Relevant Work Experience
7-8 years in the field of product development and/ or project management in Pharmaceutical industry