Job Information
Sun Pharmaceuticals, Inc Manager - Project Management in India
Job Description
Job Title: Program Manager /Associate Program Manager (Branded Programs)
Purpose: Primarily responsible to drive the branded programs products market extension. This includes establishing the bridge between management and various cross functional teams such as R&D, Regulatory, Manufacturing, Quality, Clinical, Business Development and Commercial. Driving the development by integrating strategic organizational objectives with functional plans. They will drive the cross-functional project teams for high value products and harnessing the maximum benefit by timely market extensions.
Roles and Responsibilities
Act as an anchor point for the filing and approval of the branded products in ex US markets.
Lead the overall execution of multiple projects, including initiation, budgeting, scheduling, monitoring, and closure
Work with the Project team to develop and maintain project plans for the filing activities of branded product.
Drive teams to deliver to the project timelines to meet key milestones, decision points with full understanding of the critical path activities. Lead project what if scenarios to arrive at aggressive and realistic plan.
Prepare registration plan; identify all critical activities required before filing and arrive at target filing date
Support & coordinate for query response to Regulatory agencies post filing
Understand the regulatory framework, including regional trends, for various types of applications and procedures across all regions.
Coordinate with external partners and drive the regulatory filings as per the agreed timelines.
Conduct and drive cross functional project meetings with clear agenda and expected outcomes. Track the action items to the closure
Coordinate with internal stakeholders like Clinical, BD, Regulatory, Development, Supply teams to align the filing plans as per the organizational needs
Proactively identify project risks, strategic influences and develop the mitigation plans to maintain project timelines
Timely highlight the issues at appropriate forum and drive the resolutions.
Effectively communicate technical and project information to the team and ensure vital communication flow within the project teams (meetings, minutes, issue/risk logs, action items etc.) and other collaborates
Compile, maintaining and track the budget for branded programs
Work with finance team to capture the expenses of the branded programs correctly in internal accounting systems
Review Budget vs actual expenses
Update the progress of the projects on timely manner to the senior management
Key Skills
Understanding of drug development process and regulatory landscape
Must be highly professional, proactively take initiative, able to multitask and demonstrated ability to work well under pressure.
Ability to prioritize and successfully manage competing and complex projects and situations
Ability to work independently and influence stakeholders in matrix environment
Effective communication and presentation skills with ability to interact seamlessly across the hierarchy
Detail-oriented, organized and diligent in preparation.
Experience in leading cross-functional project team through all stages of development
Excellent computer software skills, Microsoft Project, SharePoint, PowerPoint, Word, Excel and Outlook
Qualification
Masters in any life sciences
Master of Business administration preferred
Experience
8-12 yrs experience in Biopharma industry with atleast 3-5 yrs of project management experience
Experience in Other advanced markets and EM filing
Understanding of the clinical trials (Ph1, PhII, PhIII)
Sun Pharmaceutical Inds Ltd
JOB DESCRIPTION
Position : Manager - Branded Program Management
Grade : G10
Experience
Job Description
Job Title: Program Manager /Associate Program Manager (Branded Programs)
Purpose: Primarily responsible to drive the branded programs products market extension. This includes establishing the bridge between management and various cross functional teams such as R&D, Regulatory, Manufacturing, Quality, Clinical, Business Development and Commercial. Driving the development by integrating strategic organizational objectives with functional plans. They will drive the cross-functional project teams for high value products and harnessing the maximum benefit by timely market extensions.
Roles and Responsibilities
Act as an anchor point for the filing and approval of the branded products in ex US markets.
Lead the overall execution of multiple projects, including initiation, budgeting, scheduling, monitoring, and closure
Work with the Project team to develop and maintain project plans for the filing activities of branded product.
Drive teams to deliver to the project timelines to meet key milestones, decision points with full understanding of the critical path activities. Lead project what if scenarios to arrive at aggressive and realistic plan.
Prepare registration plan; identify all critical activities required before filing and arrive at target filing date
Support & coordinate for query response to Regulatory agencies post filing
Understand the regulatory framework, including regional trends, for various types of applications and procedures across all regions.
Coordinate with external partners and drive the regulatory filings as per the agreed timelines.
Conduct and drive cross functional project meetings with clear agenda and expected outcomes. Track the action items to the closure
Coordinate with internal stakeholders like Clinical, BD, Regulatory, Development, Supply teams to align the filing plans as per the organizational needs
Proactively identify project risks, strategic influences and develop the mitigation plans to maintain project timelines
Timely highlight the issues at appropriate forum and drive the resolutions.
Effectively communicate technical and project information to the team and ensure vital communication flow within the project teams (meetings, minutes, issue/risk logs, action items etc.) and other collaborates
Compile, maintaining and track the budget for branded programs
Work with finance team to capture the expenses of the branded programs correctly in internal accounting systems
Review Budget vs actual expenses
Update the progress of the projects on timely manner to the senior management
Key Skills
Understanding of drug development process and regulatory landscape
Must be highly professional, proactively take initiative, able to multitask and demonstrated ability to work well under pressure.
Ability to prioritize and successfully manage competing and complex projects and situations
Ability to work independently and influence stakeholders in matrix environment
Effective communication and presentation skills with ability to interact seamlessly across the hierarchy
Detail-oriented, organized and diligent in preparation.
Experience in leading cross-functional project team through all stages of development
Excellent computer software skills, Microsoft Project, SharePoint, PowerPoint, Word, Excel and Outlook
Qualification
Masters in any life sciences
Master of Business administration preferred
Experience
8-12 yrs experience in Biopharma industry with atleast 3-5 yrs of project management experience
Experience in Other advanced markets and EM filing
Understanding of the clinical trials (Ph1, PhII, PhIII)
Sun Pharmaceutical Inds Ltd
JOB DESCRIPTION
Position : Manager - Branded Program Management
Grade : G10
Experience : 8-12 years
Job Location : Baroda
Education : M.Pharm / M.Sc / MBA
: 8-12 years
Job Location : Baroda
Education : M.Pharm / M.Sc / MBA
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