Assistant Project Manager
4 weeks ago
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.
Tell employers what skills you have
Drug Development
Able To Multitask
MS Office Suite
Project Management
Good Communication Skills
Attention to Details
Time Management skills
CMC
Regulatory Requirements
Regulatory Submissions
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