职位描述

职位描述： Primary Responsibilities?Provide operational support to Hub Submission Manager(s) or equivalent roles within Submissions Management organization, execute designated tasks associated with submission coordination activities for assigned products and/or regulatory procedures as appropriate.?Acountable for delivering quality and timeliness as per applicable policy, SOP/Work Instructions, guidelines or service level agreement.?Command necessary knowledge and skills of regulatory submission and ensure regulatory or business requirements are fulfilled.?Adhere to the appropriate use of technical tools, through use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved.?Operate as Subject Matter Expert in dossier technical processes with responsibility for training and mentoring fellow colleagues.?Escalate, inform, and/or resolve any issues that may impact timeline, quality or compliance of submissions.?Commit to completing required on-the-job training courses to ensure training compliance is preserved.Training & Education Preferred?Degree in Pharmaceutical Sciences, Life Sciences, Business or Information Technology is preferred; equivalent relevant professional experience will be considered.?Proven technical aptitude and ability to quickly learn and use new softwares or tools.?Knowledge of drug development process and applicable regulatory guidelines.Prior Experience Preferred?Work experience in pharmaceutical industry.?Experience of working in a challenging customer service environment.?Demonstration of attention to detail.?Solid experience and/or formal training in office tools.Technical Competencies:?Knowledge of the tasks performed by relevant lines in drug development, and the relative priorities and interdependencies?Breadth of knowledge and experience with the utilization of variety of software applications and/or tools. Technical proficiency is a key competency for this role.Behavioral Competencies:?Works collaboratively with group members and contributes to positive intra- and inter-team relationships?Looks for opportunities for collaboration and acts upon them?Analyzes and solves problems to make effective decisions?Able to foresee potential conflicts and problems related to schedule or resource needs and provide suitable solutions/options?Seeks quality in all elements of the plans to provide high quality information and recommendations?Responds to changing situations and others’ ideas that differ from own positively and constructively 职能类别： 政府事务管理

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