Role/Job Description: (to be filled by the proposer):
- Dual role - CMC project manager and Program manager for a single asset
- Develop project plan in msp and excel for biosimilar insulin CMC program for US and EU. Conduct weekly CMC review meetings along with Project Leader (PL) to track and report the progress and performance
- Integrate CMC project plan with CPC project plan (comes from CPC project manager – service provider to CMC project manager) to prepare an integrated program level plan
- Conduct CMC and CPC cross functional team meeting fortnightly to bring all stakeholders on the same page, resolve conflicts, determining priorities and identifying escalation points to Head, R&D and BU Head
- Lead preparation for the SC meeting and internal management review forums like QVR, Board presentation
- Prepare budget, track and manage the expenses. Major focus on third party expenses
- Manage procurement of reference product procurement for CMC, preclinical and clinical studies
- Lead rate negotiation with third party service providers and liaise with finance, Head R&D and BU Head
- Lead contract negotiation with third party service providers and liaise with legal, finance, Head R&D and BU Head
- Work with cross functional team members to improve Biocon’s systems and process to remove redundancies and bottlenecks
- Work with peers in PMO office to continuously improve the project and program management function
Technical / Functional Skills:
- Basic Project management experience (at least 2-3 years)
- Medium proficiency in .msp and project management tools (at least 2-3 years)
- CAPM / PMP certified (optional)
- Prior experience in R&D / RA (optional)
Behavioral / Management / Other Skills:
- Team player as it involves managing a big team involving senior leadership like Head R&D and BU
- Excellent written and oral communication skills
- Good articulation skills - Required in SC and QVR meetings
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