长沙招聘

Primary Responsibilities

This position reports to the locally based Regional Labeling Head or a Senior Manager in the ILG organisation.
? Utilize regulatory expertise to review, develop and deliver labeling documents such as the LPD, LLD and Patient Leaflet to support submissions to the Regulatory Authorities across regions, requesting advice or input from other functions when appropriate.
? Production of other labeling-related documentation for submission to HAs such as track change versions, annotated labels, comparison tables and annotated supportive documentation.
? The full range of labeling documentation may be produced, including labels for NCEs or Product Extensions, as well as other complex revisions.
? For deliverables in scope, support responses to inquiries from Pfizer colleagues in response to inspection activities and may provide support during regulatory agency questions.
? May coordinate labeling revisions when there is a regional, global or therapeutic area impact across multiple countries
? May mentor or train more junior labeling managers in their day-to-day activities
? Ability to run training and awareness sessions on labeling processes and ability to clearly articulate expectations of the labeling process to stakeholders.
? Takes appropriate risks to advance new concepts and methodologies that are moderately complex, participating in pilots as directed and other continuous improvement projects.
? Identifies incremental improvements to labeling-related processes and systems for exploration by more senior labeling managers.
? Meets defined targets on productivity, quality and compliance, as set by and overseen by management.
? Meets strategic targets for labeling deliverables as defined for the function, and communicates progress against these targets or issues which affect these targets, and proposes remediation.


Technical Skill Requirements
? Has thorough knowledge of the principles, concepts and theories of labeling, and awareness of principles and concepts of other labeling-related disciplines.
? Understands and applies labeling regulation knowledge in the region and in assigned local countries, and is able to interpret impact of that regulation on development of labeling text.
? Proficient in use of systems consistent with business expectations, and understands importance of systems in maintaining high compliance figures
? Fluency in English language important however multi-language skills are advantageous
? Written and verbal communications clear and effective
? Understands and applies labeling regulation in the region and in assigned local countries, and is able to interpret impact of that regulation on development of labeling text
? Understanding of the importance of Standard Operating Procedures (SOPs), systems and processes in underpinning quality and compliance of deliverables


Qualifications (i.e., preferred education, experience, attributes)

Education:
? Life sciences, pharmacy graduate or equivalent
? Advanced academic qualifications/degree such as PhD an advantage but not essential

Experience:
? Significant ‘Hands on’ registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs (Human Medicinal Products); preferably from the perspective of a Country office or Regional Regulatory Strategy important and advantageous especially with the perspective of the implications of a CDS on LPDs
? Proven ability to successfully understand regulatory implications of product strategy with regard to the produce label, assessment and practical management of associated impacts.
? Demonstrated ability to interpret and apply regional/local regulatory guidance around labeling and associated supportive documentation, both in the pre-approval and post approval (maintenance) stages
? Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations.
? Knowledge of global/regional regulatory guidelines and requirements important
? Knowledge of Clinical Variations preferred
? Proven strength in logical, analytical and writing ability essential
? Readability Testing knowledge an advantage but not essential
? Demonstrated project management, attention to detail and problem solving skills required.

On October 31, 2005, Pfizer announced the official opening of China Research and Development Center (CRDC) in Shanghai. Pfizer Global Research and Development’s Center is mainly engaged in drug development activities. Much of the facility's capacity is devoted to the study design, data management and statistical analysis of global phase I-IV clinical trials, as well as the clinical study report process. In addition, CRDC is a part of Pfizer global Safety and Risk Management and covers the functions of safety data processing and assessment. The center also trains Pfizer employees in China and throughout the Asia region in internationally recognized Good Clinical Practice standards.
辉瑞公司于2005年10月31日宣布辉瑞中国研发中心正式在上海揭幕。辉瑞中国研发中心主要为全球辉瑞药物开发提供支持工作。大部分的功能是围绕在I-IV期临床试验研究设计、数据管理和生物统计分析、以及临床试验报告的部分准备工作。此外，该中心是辉瑞全球安全和风险管理部的一个分支，负责安全数据处理和评估工作。研发中心还将为辉瑞公司在中国及亚洲的其它运营部门的员工提供国际标准的临床试验管理规范(GCP)的技术培训。