长沙招聘

Role Description
Position Purpose
The Hub Labeling manager (HLM) is responsible for executing the content management of l local product documents (LPDs) regardless of registration procedure including USPIs and Centralized Procedure SmPCs for their assigned products across multiple countries/regions.

This role will keep up to date with regional labeling regulations. Additionally the role will oversee content across all labels for their assigned products in their assigned regions and drive consistency of content and messaging wherever possible.

This role will focus on and be responsible for the production of labels referred to as LPDs, the associated Local Language Documents (LLDs); any Patient Information Leaflets (PILs) and any Technical leaflets regardless of registration status/procedure across the globe. HLMs across the regional areas will work together to ensure that labeling is updated on a timely basis according to internal SOPs and external regulatory requirements. Where appropriate, the HLM will seek advice from identified roles when authoring text that deviates from the core.

This role will interface with Global Labeling Leads, PCO colleagues, MDL Authors, Global/Regional Medical TA Leads, Submissions Specialists and Global Labelling Operations Specialists in the delivery and management of labeling text through appropriate processes and systems to assure the timely submission and ultimate approval of Pfizer product labeling. .

This role will act as a Subject Matter Expert (SME) on regional and multi-country regulatory labeling requirements and participate in the sharing of intelligence. Additionally this role will support the use and development of current and new tools, technologies and processes to support global label development, submission and approval in respective countries


Primary Responsibilities
This position reports to the locally based Global Labeling Management Team Lead.
Utilize regulatory expertise to review, develop and deliver core labeling documents such as the LPD and Patient Leaflet to support submissions to the Regulatory Authorities across regions, requesting medical advice from others when appropriate.
Engaged in necessary labeling team meetings to discuss any decisions for not making any label updates or discuss any findings of meaningful differences for registration types specific to USPIs, CRP-SmPCs and MRP/DCP-SmPCs as necessary
Employ a consistent approach to the content of labeling documents assuring that governing SOPs and IGs are followed and external regulations are met
Ensure that decisions taken for labeling are accurately captured and communicated to appropriate stakeholders so that local and regional submission activities can be triggered in a timely fashion.
Communicate, plan, prioritize and deliver submission documents according to company targets and submission requirements; liaise with stakeholders using the most effective means of communication; presenting information in an optimal format and level of information for that audience
Ensure all actions taken within role follow applicable SOPs and IGs so that high quality delivery of outputs and compliance is maintained. Ensure appropriate tracking of labeling projects via defined procedures and optimal use of systems. Champion and/or participate in continuous improvement efforts related to business practices and tools utilized within role.
For deliverables in scope, support responses to inquiries from Pfizer colleagues in response to inspection activities and regulatory agency questions.

Technical Skill Requirements
*Knowledge of global/regional regulatory regulations and guidelines pertaining to labeling especially
clinical submissions and demonstrated ability to decipher and understand implications of label changes both pending, approved and historical across document types and geographical regions/countries
*Demonstrated ability to understand, analyze and propose information into local labeling such as the LPD and Patient information and ability to logically review any impact on other sections of the same documentation
*Fluency in English language important however multi-language skills are advantageous
*Written and verbal communications clear and effective

Resources Managed (budget and FTEs)
*No direct reports; individual contributor role

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 (at a global/multi-national pharmaceutical environment). Experience at the country level important and advantageous especially

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。