Project Manager

Project Manager - 53988

The opportunity

The Project Manager has overall responsibility for leading the global development of R&D Generic products; ultimately to maximize the product’s potential. The PM may work in partnership with a Project Leader to establish, maintain and deliver the product plan for Gx assets.

The PM is responsible, under limited supervision, for managing, planning, and tracking of development activities of multiple projects in accordance with the approved project strategy within our Generic R&D business. PM will lead a cross-functional team and be accountable for managing time line, cost, and quality. The responsibility starts when a project is approved for development and ends when a project gets the agreed upon approvals on respective markets. In addition the PM will support any launch activities including transfers from R&D to Ops. PM will help prepare information for periodic review by the Steering Committee.

How you’ll spend your day

1. Lead the cross-functional project team to secure approval and funding for the overall product development plan and through the strategic planning and delivery of the development program, proactively identifying and managing issues and risks and ensuring decisions are made at the appropriate levels and with the appropriate cross-functional input.
2. Lead cross-functional delivery to the agreed development budget and timeline – collaborating with the cross-functional team members to track and manage issues in budget and timelines and bringing significant variations to R&D management for approval based on agreed trashold
3. Report accurate project status and escalate issues whenever they cannot be resolved within the team
4. Collaborate with function leads to ensure their teams are fully resourced and skilled appropriately to deliver, working expeditiously to highlight any resource gaps that impact the program delivery or quality. Participate in sub-team Managership.
5. Lead quality risk management to ensure significant risks to the programs have planned mitigations and are flagged in terms of likelihood and impact, to the relevant Managership.
6. Develop and manage end to end product development plans in Planisware to accurately reflect the tactical plan/timeline and interrelated functional.
7. Ensure all relevant documentation is accurate, current, and approved by respective Managership.
8. Manage multiple projects, programs or a large portfolio of inter-related projects

Your experience and qualifications

1. Bachelor’s level degree in the Chemistry or biotechnology field
2. 2-3 year’s experience in the pharmaceutical industry and at least 1 year managing development projects (Generic) through to registration and launch
3. Solid understanding of drug development (Gx), industry guidelines, and regulatory and submissions processes globally
4. Experience in effective and influential oral presentations
5. Project Management Professional (PMP®) preferred
6. Excellent computer software skills, specifically – Planisware / Microsoft Project, SharePoint, PowerPoint, Word, Excel and Outlook
7. In-depth knowledge of the drug development process in Specialty