Job Description
Job Location: Prashanti Nagar IE Kukatpally Hyderabad, TELANGANA 500072
Job Shift: DayThe Executive - PMO will be primarily working in the domain of Launch Management and Life Cycle Management of commercial products for the US and other regulated generics markets such as EU, Canada etc. The primary responsibilities will be as follows:
- Managing New Product Launch Activities for both internal and client projects.
- Managing Life Cycle projects for commercial products, both internal as well as with out-licensing partners.
- Work with clients, contract manufacturing sites and other partners for timely delivery of the projects.
- Implement project management tools and methodologies to track the project progress and identify potential risks.
- Communicate with all relevant departments to facilitate day-to-day operations and meet project deadlines.
- Establish Confidentiality Agreements and Quality Agreements with CMOs,
- Select external labs for project-specific needs and collaborate with them to ensure project completion.
- Ensure the availability of project pre-requisites at every stage of project launch to facilitate smooth execution.
- To ensure the seamless execution of validation and launch batches at Contract Manufacturing Organization (CMO) sites.
- Prepare regular Project status presentations for stakeholders, summarizing project progress, issues, and risks including meeting minutes.
Qualifications
- MBA/MPharm Preferred
- 2-4 years relevant work experience handling project management/ launch management for the US generics market.
- Familiarity with cGMP, GLP, and regulatory guidelines like FDA, EMA, or ICH.
- Understanding drug product manufacturing, and product lifecycle management.
- Ability to lead cross-functional teams and manage diverse stakeholders.
- Strong verbal and written skills for effective collaboration and reporting.
- Analytical thinking to address challenges and implement solutions.
- Flexibility to navigate dynamic project requirements and industry changes.
- Proficiency with standard tools such as Excel, MS Projects, Smartsheet etc.
