職位描述
Job Discreption:
Generate CTA/NDA package including timeline, action plan, task tracking log, etc. for other project leads; Gather local development needs through attending local asset team meetings and interating with other functions, propose China strategy/timeline for your projects, compare local and global plans, identify any gaps between them, highlight risk, and propose mitigation plans; Ensure PharmSci China plan for your projects, including timing of key PharmSci deliverables and associated resource/budget forecasts are consistent with candidate milestones, overall Pfizer China and PharmSci development strategies
Requirements:
PhD with technical experiences in drug development disciplines such as API, DP, Analytical, Quality etc.; Able to fluently communicate in Chinese and English and work outside normal working hour; Portfolio management skills related to project strategies, timeline, resource, and budgets;
Q & A:
PharmaScience is responsible for pharmaceutical development, clinical operations support, and regulatory compliance, ensuring quality and efficiency across global and China-based drug development programs
What are the primary academic disciplines required for the PhD in this position??? (Chemistry, Biology, Molecular Biology, Biochemistry, Bioengineering, Pharmaceutical Development, or other drug development related disciplines. Please feel free to send the CV to me if you are not sure if the background fits our JD.)
??Which departments and other project leads are the key collaborators for this position??? (China Regulatory (The dossier we draft will send to them for submission.), Supply Chain (The clinical supply we manufacture will send to them to ship to clinical site.), Clinical (Their clinical study design impacts how to manufacture supply.), Clinical Operation (Their timeline decide when to manufacture supply, Commercial, and PM (Resource and budget needs). US technical and manufacturing leaders to decide what and when to provide for China filing and clinical? supply.)
?At which stage of drug development is this role primarily focused to support (From phase 1 to NDA approval)??
Travel Expectations (Limited) and/or work schedule (Routine evening calls with the US key stakeholders)
What comparable positions at the target company align with this role's requirements (I don’t know what Pfizer PharmSci is called in other companies. We can train the lead for analytical, formulation, regulatory, supply chain, API synthesis, etc. if other criteria are met.)?
Target on board date and M&G process (Flexible. Depends on when we can find a qualified candidate.)????