Job DescriptionDescription:Project Planning and Execution: Define and manage the scope of post-approval projects. Develop and track project timelines to ensure timely completion. Set and achieve key milestones throughout the project lifecycle. Stakeholder Communication: Coordinate with R&D, manufacturing, marketing, and other departments. Communicate with regulatory bodies, healthcare professionals, and other stakeholders. Provide updates to internal teams and external partners. Documentation and Record Keeping: Maintain accurate records of compliance activities and changes. Keep thorough records of project plans, progress, and outcomes.
Essential Functions:- Introduction and tracking of new post-approval projects when received from SSSM or other cross-functional departments. Tracking of Existing material Inventory and highlight the importance of post-approval project completion. Coordinating with supply chain and procurement department for procurement of API samples, impurities and submission batch qty. Tracking of Vendor qualification and Method Validation and Verification activities on daily basis. Coordinating with CFT's on documentation, specification, method preparation and revision requirements. Tracking and scheduling the timeline for release of the material and drug product. Coordinating with operations for the submission batch schedule and stability initiation. Tracking of post-approval project throughout the completion of stability, filing and approval. Coordinating with RA and other CFTs for required filing documents and submission timeline. Providing confirmation of grant/approval status and implementation of post-approval project at commercial scale. Providing numerical data on cost-saving/alternate source projects.
- Project Selection: Actively participates in the supply chain management and forecast meetings. Mentors Senior Manager of Strategic Portfolio Management on the process and target products consistent with the company's strategic objectives and based on knowledge of Brand and Generic pharmaceutical markets.
- Business Development: Works closely with Business Development and Corporate Development to identify and evaluate opportunities for alternate source and cost saving projects. Builds financial models to determine value and potential deal structures. Conducts due diligence on BD opportunities.
- Planning: Works closely with supply chain management, Operations, and Project Management on project timing and projections to ensure a smooth and effective completion of projects from either internal or external facilities. Assesses and provides critical input on timing, market dynamics, etc. that drive near- and long-term forecasts for Finance and Tech Ops.
- Market Intelligence: Analyzes products, markets, regulatory issues, companies, therapeutic categories, etc. to drive decisions on portfolio and new opportunities.
QualificationsEducation:- Bachelors Degree (BA/BS) Relevant Field - Required
- Master Degree (MBA) Relevant Field - Preferred
Experience:- 5 years or more in Minimum of 5 years of pharmaceutical industry experience with at least 5 years in the generics industry.
- 5 years or more in 5 years required managing people, projects a functional area or a combination of the above.
The base salary for this position ranges from $120,000 - $130,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.
At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities
