Job Summary (Primary function)
The Project Manager, Global Launch Projects - Partner Markets plays a key role in operationalizing the alliances and partnerships projects for pre-commercial and launch activities with external vendors and partners. This role has a global exposure and requires advanced project management capabilities as well as effective communications skills. The person in this role would be responsible for leading key strategic project (such as Commercial Product Launches and Product Life Cycle Projects) affecting the Global Technical Operations organization.
Essential Functions of the Job (Key responsibilities)
·Support activities required within process chemistry, pharmaceutical and analytical development to ensure submission readiness of drugs into international markets.
·Manage the GMP/GDP readiness of new products for international markets.
·Provide support to analytical testing activities (registration, method transfer and import testing).
·Coordinate information and data sharing with existing alliance partners, such as CMC information and data, and manage data repository building and folder information.
·Prepare and organize documentation as part of strategic partnership evaluation (e.g., REALM program).
·Manage and lead cross-functional project and/or program teams, ensuring diverse perspectives and inclusive collaboration.
·Ensure benefits, scope, goals and deliverables are well defined and understood by the team and stakeholders.
·Lead team meetings and ensure that meeting agendas and minutes are issued in a timely manner.
·Ensure defined deliverables are met in timely manner.
·Develop full-scale plans and timelines with input from all required departments including: (a) draft and submit budget proposals and recommend subsequent budget changes where necessary; (b) schedule and track milestones and deliverables using appropriate tools; (c) identify and manage dependences and critical path.
·Ensure that communications between teams, functional management, senior management, and executive leadership are handled in an efficient, effective, and timely manner, using inclusive language and practices.
Qualifications (Minimal acceptable level of education, work experience, and competency)
·Degree (such as Bachelor's) in Business or related discipline, or equivalent experience.
·Relevant certification in Project Management is highly valued.
·Broad knowledge of Pharmaceutical Quality, Manufacturing and Supply Chain and GDP/GMP practices.
·Demonstrable experience in project management, including managing multiple demands and diverse and virtual teams globally, while delivering global projects successfully – in scope, on time and within budget.
·Effective communication skills, both verbal and written, across all organizational levels are essential.
·Proactive, pragmatic, and able to work independently while building trust and creating collaborative environments and relationships with cross-functional, diverse teams.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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