Job Description
- Project support: Oversee and support project management activities, including planning, timeline monitoring, and budget tracking, to ensure timely completion of projects for regulatory submissions.
- Project monitoring: Track and report project status to internal and external stakeholders, ensuring deadlines are met for ongoing projects. Provide expert CMC support while monitoring CMO/CDMO activities.
- Documentation management: Manage and maintain project documentation, including protocols, reports, SOPs, and meeting minutes. Facilitate the collection of information from both internal and external stakeholders in a timely manner.
- Stakeholder management: Coordinate external collaborations, including managing agreements and overseeing the quality of deliverables. Monitor activities of CMOs, CDMOs, and other partners.
- Sample and logistics coordination: Handle project logistics, including sample shipment and drug sourcing.
- Regulatory support: Assist in drafting the Quality Section of dossiers for clinical trial and marketing authorization applications, ensuring alignment with regulatory requirements and agency expectations.
- CMC support: Offer strategic guidance to technical teams on CMC regulatory requirements and engage in negotiations to resolve CMC-related issues.
- Others: Perform other duties as assigned by leadership
Job Requirements
- MSc, or BSc in life science/ chemistry
- Experience with office management software like MS office (MS Excel, MS Word, MS PowerPoint) and other project management software
- Strong management and organization skills, attention to details, good written and verbal communication skills
- Superior time-management skill, able to multitask and quickly adapt to dynamic changes
- Knowledge in drug development process and technical/ scientific knowledge.
