武汉招聘

Position Summary   

Provide regulatory relevant technical solution and management support to serve the approval of clinical trial and/or marketing authorization for pharmaceutical products. Manage and publish the regulatory submission packages in the format which meets regulatory agencies’ requirements. Provide technical support for the business applications and systems to achieve the outcome.   

Key Responsibilities

• Manage and Publish the Regulatory Submission Packages.

1. Publish the regulatory submission relevant documents to agreed submission ready criteria.
2. Execute the compilation and publishing of project specific submissions to agreed quality standards.
3. Responsible for the archiving and other activities which associated with regulatory submissions within agreed timelines.
4. Adhering to quality control procedures and standards related to document and submission publishing.
5. Participate in the definition and implementation of regional process efficiencies for submission publishing and project learning sessions.     

• Provide Technical Support for the Business Applications and Systems 

1. Adhering to the appropriate use of document management systems, publishing and validation tools, with working practices and quality control steps to ensure regulatory compliance.
2. Contribute to business applications or system validation, implementation and testing, and provide technical consultation for business needs.
3. Identify problematic areas and provide trouble shoot solutions in time.

• Other Relevant Support 

1. Support other function lines with publishing and other knowledge about documents and submission processing when necessary.
2. Potential to develop into a subject matter expert (SME) to train and coach colleagues.
3. Ensure security of data, network access and backup systems   

Education and Key Competency Requirements  

• Bachelor’s degree or above in life science or information management related field.
• Proven technical aptitude and ability to quickly learn and use new software.
• Excellent verbal and written communication skills in both English and Mandarin, able to communicate effectively with colleagues and stakeholders.
• Working experience in pharmaceutical industry and knowledge of regulatory requirements is a plus.
• Demonstrate time management and project management skills for successful milestone/timeline achievement. 
• Strong organizational and planning skills in order to meet timeline requirements and to handle multiple projects whilst showing prioritizing skills.
• Ability to work effectively in a multi-cultural context and matrix organization.
• Demonstrated of experience working in a customer service environment.                  

全球知名生物医药企业资深研发团队打造的创新服务公司。让你的职场起点更高，更充满挑战和精彩。
 
我们是谁？
 
    基于中国面向全球制药，生物技术和医疗器械公司的临床开发服务和解决方案提供商:
· 临床试验全程及专业领域服务：临床试验设计、数据管理及系统开发、生物统计及编程、运营和项目管理、报告撰写、注册运作和策略、质量保证和稽查、药物安全警戒和风险管理
· 战略咨询服务：临床开发和注册策略、研发功能和架构设计、技术支持和国际化支持。
 
为什么选择我们？
 
· 缔脉定位于以高品质服务和专业精神成为业界典范。
· 缔脉管理层在中国生物医药研发领域耕耘十多年培养了1000+优秀人才。
· 缔脉致力于通过系统培训，研发实践和开放式文化培养新一代生物药物研发国际化人才。
 
创始人及部分核心专业领域


创始人 - 谭凌实博士：拥有20多年跨国一流制药公司总部高级管理经验。此前担任辉瑞公司全球药物开发运营副总裁，在中国成功创建了首屈一指的研发中心，且经历10多年发展壮大到多个地点，成为辉瑞全球核心的研发中心之一，承担药物临床开发、安全风险管理、注册、临床稽查等关键职能。谭博士多年为RDPAD, DIA 的核心成员，担任重要职务,包括研发委员会主席, 全球董事等。谭博士还带头建立了与国内一流高校的教育培训合作，比如复旦大学、北京大学，交通大学。培养了不少拥有专业技能和行业知识的临床数据管理和编程人才。谭博士有在美国建立初创企业的经验，且在美国一流制药企业研发中心工作多年。谭博士拥有生物统计博士学位。