Global Program Management - Biosimilars

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have proven end to end expertise in the field of biosimilars, from its development, manufacturing, clinical development, regulatory approvals to commercialization. We have a long-term commitment to bring high quality affordable biosimilars to patients all over the globe.

Job Responsibilities:

Program and Project Management for Development Programs which are biosimilars:

• Business case approvals, Project charter preparation, Project management
• Develop & Manage project schedule, Track the execution, budget commitments and spends.
• Responsible for successful delivery of the projects on-time and within approved budget.

Follow the Governance Structure and Escalation Matrix as defined within Global Program Management function

Scope and Schedule management: Finalize the Project scope and plan.

• Track the Plan Vs Actual and report the variance.
• Pro-actively build scenarios for impact mitigation and minimize delays
• Monitor the progress through-out the project lifecycle using scheduling tools (MSP, Office timeline)

Stakeholder management: Co-ordinate with cross functional teams for the program deliverables. Manage communications, escalation & problem solving to ensure project deliverables stay on track

Budget: Plan the program budget (Annual/Quarterly/Monthly).

• Budget forecasting for the Development programs Liaise with Finance, R&D, Regulatory, Clinical & Ops team & finalize the budget forecast for the Fiscal year
• Finalize, Track and Report the Plan vs Actuals
• Negotiation with the service providers/ CROs for the program related activities.
• Monitor/control project progression to ensure project is completed on schedule and within budget. Anticipate and provide visibility to internal/external stakeholders for scope/cost creep & revision

Regulatory:

• Ensure data package readiness for dossier submissions.
• LCM Program: Liaise with RA team and finalize the regulatory pathway for variation filings
• Liaise with the cross function teams for response submission to the agency queries on time.
• Facilitate the plan and data readiness for the scientific advice / feedback from regulatory agencies.

Legal:

Liaise with the Legal team and ensure readiness of CDA, MSA, SOW before engaging with the external vendor and CROs

Logistics: Liaise with Procurement and Logistics teams to facilitate and track the shipments (project related materials, test items/drugs, testing/biological samples)

Procurement: Liaise with procurement team for the availability of project related consumables, equipment & other critical reagents required for the program

Technology Transfers: Project Management of technology transfers to third party service providers (CMOs) and/or technology transfers from third-party sites to inhouse facilities.

PMO responsibilities:

• Develop systems and processes to enhance efficiency of Operations.
• MIS and Management reporting
• Inculcate project management ways of working among CFTs
• Identify business enhancing opportunities that can be proposed as projects