Role Overview:
Experiencia, cualificaciones y habilidades interpersonales, ¿tiene todo lo necesario para triunfar en esta oportunidad? Descúbralo a continuación.
The Global Project Manager (GPM) is responsible for planning, coordinating, and tracking global biosimilars development projects from early development through regulatory submission and lifecycle management. The role ensures cross-functional alignment, timely execution, and adherence to scope, budget, quality, and regulatory requirements under the guidance of senior leadership.
Specific responsibilities:
- Support global biosimilars development projects across functions (CMC, Nonclinical, Clinical, Regulatory, Quality, Supply Chain).
- Develop and maintain integrated project plans, timelines, milestones, and deliverables.
- Track project progress, risks, issues, and dependencies;
escalate as appropriate.
- Organize and facilitate global project team meetings, governance forums, and documentation.
- Ensure compliance with global regulatory requirements (EMA, FDA, WHO, ICH).
- Coordinate preparation of project reports, dashboards, and development updates.
- Support submission planning activities and change management.
- Foster effective communication across internal teams and external partners (CMOs, CROs).
What are we looking for?
- Education: Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Engineering, or related field (Master's preferred).
- Languages : Fluent English (spoken and written) is mandatory, as the role operates in a integral, cross-functional, and multicultural environment. Additional languages are a strong plus.
- Experience:
- 5-10 years of experience in pharmaceutical or biotechnology development, preferably biosimilars.
- Minimum of 3 years of experience in project management.
- Great understanding of biosimilars development pathways and regulatory expectations.
- Experience working in cross-functional, global project teams.
- Skills:
- Strong organizational, communication, and documentation skills.
- Proficiency in project management tools (e.G., MS Project, Smartsheet, Planisware). xhfqzwm
- PMP or equivalent certification is a plus.