Manager
Year Tandalja, Vadodara, Gujarat, India
Job Description
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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
- 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
- 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 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
- 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
- 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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Job Detail
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Job IdJD3334817
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationTandalja, Vadodara, Gujarat, India
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EducationNot mentioned
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ExperienceYear