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辉瑞（中国）研发 招聘药品注册出版小组leader
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职位名称：Publishing Team Manager Role Description Organizational Relationship(s) including to whom the position reports (title): • Head SOS PPLS China or Global Head PPLS Position Purpose To Manage publishing activities at the regional level ensuring that Pfizer delivers on key regulatory submission milestones and maintains compliance with applicable regulatory obligations. At times of peak load across the organization, the incumbent is expected to publish submissions, and at all times will have comprehensive and detailed oversight of quality control and regulatory workload within their function. Primary Responsibilities • Ensuring successful portfolio delivery to designated health authorities to agreed time and quality standards. Managing the resources associated with compilation, publishing and delivery of all marketing applications that support new development projects and maintain regulatory compliance for investigational new drug applications and existing marketed product applications. • Key Accountabilities: • • Direct and active supervision of a subgroup within Submissions, specifically focused on a subsection of the portfolio or type of specialist support to the business. • Proactive liaison with remote customers within designated region to ensure streamlined product delivery • Coordinates with remote/local peers to ensure compliance with local and global regulatory requirements • Ensures that assigned projects/technologies relating to evolution of submission build, publishing and delivery processes and deliverables are carried out according to timelines • Coordinates load balancing and resources at the respective site and in support of remote sites • Develops ideas seeking efficiencies and effectiveness while managing the submissions portfolio • Responsible for professional development through mentorship and motivation• Technical Skill Requirements • Understanding of the concepts around regulatory affairs and significant knowledge of submissions processes. • Functions as a change agent that can exhibit regulatory knowledge and awareness, technical competence, sound judgment, and a professional demeanor. • Articulate with strong analytical and interpersonal skills • Proven aptitude in project management and process redesign • Proven ability to work successfully on global teams.• Qualifications (i.e., preferred education, experience, attributes) • Supervisory and publishing experience • Master’s or Undergraduate degree plus relevant experience • Project Leadership • Regulatory Expertise: Demonstrated knowledge of Regulatory submissions, code, guidance, specifications, and eCTD technologies. • Communication Skills: Ability to communicate complex information and analyses to a variety of audiences in both verbal and written format. • Technology: Experience with publishing software, XML, Document Management, regulatory milestone reporting tools • Project Management skills : Mastery of processes, tools and techniques for planning and monitoring projects to established deadlines. Familiarity with pharmaceutical organizational structures, systems, and culture. 简历请发送至：13012828472@163.com |
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