Project Manager - R&D

Role & responsibilities

1. Overall responsible for timely delivery of assigned projects

2. To provide on-time & effective management information to key stakeholders, like Project team / Cross-functional team.

3. To employ project management processes, practices and tools for effective monitoring, control, and communication.

4. Identify potential risks and challenges associated with pharmaceutical development and manufacturing, and develop mitigation plans to address them.

5. Proactively manage and communicate project-related risks to relevant stakeholders.

6. Initiate and collaborate with peers, cross functional team, to manage, control, and monitor issue, scope, timelines, budget & Risks.

7.To provide on time communication on risks, quality, schedule, scope and overall possible variation/ deviation from approved plan / baseline schedule.

8. To ensure & facilitate inter-functional / inter departmental resolution on issues/constraints.

9.Work closely with all cross functional teams to help / arrange all reports / information to regulatory affairs teams for on-time submission of dossier for regulatory approvals.

Scope:

1. R&D project Management: Initiation to Filing

2. Filing to Launch’ Management: Ensure timely approval & Launch

3. ‘Alternate Vendor Development’ Project management

4. ‘Site transfer’ project management

Working methodologies and practices:

1. Daily follow up and activity tracking in R&D projects

2. Weekly Cross functional review meetings with R&D/ ADL/ Bio study / RA/ Tech Transfer/ QA/QC/ Procurement / Operations.

3. Periodic meetings with Business Development/ Marketing team on product delivery status and plan.

4. Software based (SAP PS module) project scheduling.

5. Software system-based project reports on schedule, activity planning and resources.

6. Risk Identification exercise with Subject Matter Experts on each development projects.

7. Planning and monitoring Risk Management plan

8. Monthly report / Monthly meeting.: Communication on status, Issues, Constraints, Escalation matters, Deviations, change control,

Baseline Vs Actual Schedule, updates on Risk plan etc.