Job Title: Program Manager (Branded and Biologics) Purpose: Primarily responsible to drive the branded programs product development. 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, high cost drug development programs.
Roles and Responsibilities Act as an anchor point for the project/program and ensure timely development, filing, approval and launch of the products. 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. 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.Drive the execution of projects in partnership with Project Leaders and SMEs from R&D, quality, manufacturing, clinical etc.Collaborate with all cross functional teams and ensure that required expertise and quality is built into the project.Identify potential resource constraints and propose mitigations.Conduct and drive cross functional project meetings with clear agenda and expected outcomes. Track the action items to the closure.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.Drive to obtain cross-functional inputs in support of and preparation of clear project progress presentations to enable decision making and progress tracking.Proactively identify project risks, strategic influences and develop the mitigation plans to maintain project timelines.Help ensure that critical decisions are taken and documented in a structured and timely manner with input from appropriate stakeholders.Timely highlight the issues at appropriate forum and drive the resolutions.To coordinate with internal stakeholders, third parties/vendors for multidisciplinary activities to ensure that the project deliverables are on-time, within budget and in quality.Effectively apply Project Management principles, methodology and ensure project documentation and reporting is maintained in consistent manner.Partner with stakeholders to identify opportunities and solutions to realise the efficiencies in the development.Responsible for integrating and preparation of Branded portfolio budget.Key Skills Understanding of biologics and biosimilar drug development, industry guidelines, regulatory and submissions processes in India and globally.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, specifically Primavera / Microsoft Project, SharePoint, PowerPoint, Word, Excel and Outlook.Qualification PhD/Masters in life sciences.Masters in Business administration preferred.Experience 10-15 yrs experience in Biopharma industry with at least 3-5 yrs of project management experience.Experience in large molecules (Biological) process development and manufacturing like Biosimilars, antibodies, Biotherapeutics, etc.Experience of handling clinical trials (Ph1, PhII, PhIII), CROs would be an added advantage.
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