长沙招聘

Organizational Relationship(s) including to whom the position reports (JD Job Title):
This position is at the Senior Associate or Manager level and colleagues in this role report to one of the Artwork and Labeling Implementation Regional Lead roles in ALIM and will be responsible for the implementation of new or revised secondary packaging components and/or labeling artwork for Biopharmaceutical products for assigned markets or groups of markets

Colleague works under the direction of ALIM leadership and liaises between the Worldwide Regulatory Strategy (WRS), Global Labeling Management (GLM), Pfizer Global Supply (PGS) plants and relevant Demand Management groups to coordinate regulatory timelines for Artwork implementation and assure product supply is not impacted.
No direct reports as this role is an individual contributor. No direct budget/cost center management responsibility.

Position Purpose
Colleague fundamentally performs the ePALMs “Market Coordinator” role on behalf of WRS/Pfizer Country Offices (PCOs) and the central point of contact in Regulatory for the PGS plants/artwork centers.

This role is responsible for initiation of Pfizer artwork requests (PARS) on behalf of WRS PCOs and coordination of logistics across multiple Pfizer markets and/or departments to assure regulatory timelines for Artwork implementation are met and that product supply is not interrupted.

Colleague is responsible for coordinating the change control logistics for implementation of finial printed labeling content into secondary packaging components; operates in an above and/or across country “hub” capacity on behalf of assigned markets or market clusters.

Colleague also will periodically track or report on KPIs (e.g. volume, timelines, and/or quality metrics) if requested. However, accountability for final quality of content rests with the PCOs or functions creating that content.

There may be times that the colleague is expected to help support workload in other ALIM lines if/as required or assigned. Finally, colleague may need to research errors for AQRT meeting or retrieve documents in response to queries from to legal during product litigation cases related to labeling in distribution.

Primary Responsibilities
Liaises with PCOs to gather and/or coordinate receipt of necessary information (e.g. editor’s copy and local or regional requirements) for labeling artwork initiation and implementation; initiate Pfizer artwork requests (PARs) on behalf of PCOs for inline product revision/maintenance.
Liaises with GLM function, WRS/PCOs and PGS artwork centers to coordinate any unique factors that need to be considered and document agreement on labeling artwork timelines. Escalates any issues/concerns within ALIM functional line and/or leadership for adjudication as necessary.
Raises and manages change controls using Pfizer’s ePALMS Artwork repository according to agreed timelines and established procedures, by performing the following activities:
? Evaluate PGS sites impacted by labeling updates
? Initiates Pfizer Artwork Requests (PARS) on behalf of assigned market(s)
? Ensures attributes (system metadata) are correct, and ensure all relevant regulatory documents are included and routed
? For any shared packs assures that agreed upon content is received in appropriate format and is either reflected in a combined editor’s copy (EC) or as a separate EC for each market according to regional agreements and relevant job aids
? Sends PARS to all relevant PGS sites
? Upon receipt of final draft artwork, reviews proofreading report from PGS artwork center and resolve any technical formatting questions or errors; Performs any necessary proofreading of final printed artwork against editor’s copy using appropriate tools; escalates any issues, questions or errors within ALIM functional line or appropriate Markets for adjudication as needed
? Initiates, manages and tracks any necessary rework
? Routes PARs and/or Artworks for approval to list of stakeholders and/or Markets; monitors progress and follows up as needed with appropriate PGS artwork centers or WRS PCOs to assure agreed timelines are met
? Tracks and communicates final approved labeling to list of relevant departments and stakeholders following final market review and signoff
? Evaluates content of labeling updates and raises potential issues with WRS, PGS or relevant local Markets as appropriate to minimize impact on schedules and packaging artwork
? Uses biopharmaceutical packaging & artwork knowledge, in combination with Trade Dress Style Guides, EU Country Specific Requirements and/or other appropriate guidelines while collaborating with PGS artwork centers to assure accurate packaging Editor’s Copies (EC’s); escalates issues or concerns if/as needed
? Identifies appropriate Market Approvers for packaging artwork and electronically routes for approval using ePalms lifecycle management.
? Interacts and follows up with all Market Approvers, as needed, and address regulatory content issues as they arise during the approval process.
In addition, at Manger level is expected to take on somewhat broader cross-functional team responsibilities, such as:
? Leads teams in development and revisions of relevant SOP’s for functional area
? Work with minimal direct supervision as well as provide in training and support to other team members or external vendors as required
? Oversees work of temporary personnel or external vendor as needed; tracks progress, monitors and intervenes if necessary; considers and adjudicates questions; assures volume, timeline, and/or quality performance metrics are met
? Participates on cross-functional systems development and/or process improvement projects as assigned; contributes and advises teams responding to new or revised legislation, regulations or guidelines for assigned market or region
In addition, at Senior manager level is expected to apply a broader “end-to-end” perspective of artwork & labeling change management by serving in a Project Management Capacity as follows:
? Collaborates closely with other centralized hub functions (e.g. GCMC, Global Submissions, Global Labeling Mangers, etc.) to minimize multiple hub interfaces for PCOs
? Coordinates artwork change controls across multiple markets/regions to assure timely agreements across stakeholders and manages complexity and logistics of many variables resulting from multi-market shared packs (e.g. incompatible preferences or requirements for content or text positioning, varying local BoH timelines or review schedules, differences in definition/expectations for artwork implementation, etc.)
? Monitors artwork progress across ALIM supported regions or projects by leveraging ALIM, PfLEET or ePALMS reports (e.g. potential stalled PARs), and intervening with PCOs, Plants, or ALIM Peers as needed to assure target KPIs and artwork implementation dates are met.
? Monitors Regional or Country Specific Artwork requirements and assures PCOs have the necessary transparency into artwork “implementation” if/as requested. Follows up with PCOs in case of implementation delays and negotiates between PCOs and Plants if/as needed to achieve agreement on revised Implementation dates (e.g. due to manufacturing schedules, product demand, inventory management issues, etc.)
? Monitors volume, timeline and quality metrics across ALIM and proactively makes suggestions for improvements. This includes attending AQRT meetings and proactively recommending process improvement to ALIM Leadership that can minimize or eliminate potential future errors.

Technical Skill Requirements
Demonstrated previous experience with:
? Document management tools supporting storage, retrieval, lifecycle management and tracking of labeling and/or artwork for secondary packaging components (e.g. ePALMS, GDMS, Agile, or similar systems)
? Document review, copy editing or proofreading tools (e.g. Docu-Proof, TVT or similar tools)

Qualifications (i.e., preferred education, experience, attributes)
Education & Experience:
? Senior Associate Level: Bachelor’s degree in an appropriate discipline, plus 4-6 years related work experience.

? Manager Level: Bachelor’s degree in an appropriate discipline, plus 6–8 years related work experience (at least 2 years of which are preferred to have been in a Labeling Artwork Change Control, Labeling Artwork Implementation Management, or Labeling Artwork Supply Chain capacity).

? Senior Manager Level: Bachelor’s degree in an appropriate discipline, plus 8-10 years related work experience (at least 4 years of which are preferred to have been in a a Labeling Artwork Control, Labeling Artwork Implementation Management, or Labeling Artwork Supply Chain capacity).

NOTE:
Substantial additional relevant experience may be considered in lieu of degree; or an advanced degree in appropriate relevant discipline may be considered in lieu of some experience

Additional Qualifications/Attributes:
1. Must be familiar with Biopharmaceutical Regulatory environment and cGMPs associated with manufacturing, packaging & distribution processes as well as a basic understanding of artwork & labeling regulations and controls.

2. Must be able to collaborate with cross-functional Pfizer teams, negotiate across globally distributed affiliates & manufacturing site personnel, and communicate across multiple levels across the organization in a clear professional manner

3. PC skills including spreadsheet, database management, and presentation sofware are required.

4. Strong written and verbal communication skills required.

5. Must be able to work under pressure of tight timelines, apply judgment in ambiguous business situations and appropriately escalate issues/potential impacts

6. Strong demonstrated project management and organizational skills (PM certification or credentials are not required but highly desirable at Senior Manager level)

7. In depth knowledge of PGS manufacturing and site processes/requirements

8. Must have capacity to solicit input in ambiguous business situations, resolve conflicting inputs and make appropriate business decisions

9. Attention to detail and ability to research and respond to audit/inspection queries

10. Ability to travel (Domestic and/or International) is 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。