【Medical】Process & Enablement (Senior) Associate, EOR, ﾒﾃﾞｨｶﾙ本部 ｴﾋﾞﾃﾞﾝｽ&ｵﾌﾞｻﾞﾍﾞｰｼｮﾅﾙﾘｻｰﾁ部
Japan EOR, Process & Enablement (Senior) Associate is the Project coordinator and Operational role to provide process/vendor management expertise to ensure the operational quality and the strategic sourcing related to Evidence generation activities and other EOR activities.
Though it is expected to carry out both "Process" and "Enablement" areas, we expect the candiate maily to take the lead in "Process" managemet role.
•Establish the process of SOP development and revision and operate them properly. And, ensure the appropriate update.
•Provide the Oversights on SOP compliance and management. And, monitor appropriate action timely when issue occurs. In addition, contribute to improvement of SOP compliance rate by delivering training/Q&A list etc.
•Lead coordination within EOR or between EOR and other departments so that there is no gap among SOPs and any procedures.
•Manage and share Vendor information centrally. In addition, propose appropriate Vendors that matches the project contents, needs and policy in cooperation with Procurement group.
•Adjust Vendor assignments to avoid internal conflict.
•Consult the vendor selection according to the team’s request such as complex cases.
•Develop, manage and supervise the process of purchasing orders and contracts related to Evidence generation activities in cooperation with procurement and legal affairs group.
•Regarding Preferred vendors, set performance standards and manage regular performance review to determine whether we can outsource or not continuously
•Regarding vendors except Preferred vendors, set performance standards and review regular performance. In addition, summarize evaluation results and manage capable vender list.
•Evaluate Vendor performance assessments regularly, and manage the quality of Vendors
[Senior P&E Associate]
On top of all above, P&E Senior Associate should be able to manage following;
•Develop process & operations based on lessons learnt and best practices across Projects
•Establish long-term partnership with Third Party Vendors (TPVs), and identify preferred TPVs to put the master service agreements in place
•Negotiate contract with TPV about complex projects
•Perform CRO site audits and ensure quality/compliance risks are mitigated by using risk management framework and CAPA
Process & Enablement Project Senior Associate/Associate will be reporting to Process & Enablement Manager.
3years Clinical development experience as Lead CRA or equivalent
Lead and Manage CROs/Alliance for clinical studies incl. contracts as a representing contact for CRO
Quality management experience at least successful management and lead from preparation, execution and follow up to complete overall audit/inspection activities as a SL(Stuly Lead)/CRA leader
3years Clinical development experience as Lead CRA or equivalent at a Pharmaceutical company
Working both in R&D and Medical (>3 years each)
Clinical Project Leader/Study Leader experience
Process (Quality) Manager or Auditor experience
Working experience outside Japan
Understanding of procurement process in general
Bachelor’s degree in a scientific discipline
Master, PhD in a scientific discipline or MD or MPH
Lean Sigma training or certification
Clinical Study Delivery
External Service Provider (i.e. CROs) Management
Leadership & Communication
Negotiation, facilitation, and influencing skills
英語 English：Practical English communication skill with AZ speaking level 7/TOEIC 700
Working experience in global organization / teams
Demonstrated facilitation skills in the meetings
Adapting, adopting and managing changes
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