Artwork Implementation Manager

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Job Summary

Colleague fundamentally performs the ePALMS system “Market Coordinator” role in close collaboration with the Global Regulatory Sciences (GRS) Strategy functions at Pfizer Country Offices (PCOs) and is the central Regulatory point of contact for the PGS plants/Artwork Centers (AWC). Colleague operates from a subject matter expert (SME) centralized “hub” capacity and in some cases, may perform Regulatory Strategist roles & responsibilities where specific tasks are delegated and in line with local and global
SOPs/Work Instructions.
 

As a seasoned “Market Coordinator” within ALIM these colleagues perform all activities of their more junior level peers including:

Initiation and “build” of Pfizer Artwork Requests (PARs) in collaboration with local markets, assuring all required information, specifications and/or supportive documentation is available for plants/AWCs to execute the production of product Labeling related packaging components.Negotiating Artwork Change Control logistics across multiple Pfizer departments (as well as multiple markets) to assure Regulatory timelines for Implementation are met and that product supply is not interrupted.Tracking Artwork, Key Performance Indicators (KPIs) (e.g. volume, timelines, and/or quality metrics) for assigned projects as well as broader regional or ALIM department deliverables when required. Accountability for Final Label Content rests with the PCOs or functions creating content.Research into root cause assessments for internal ALIM Quality Investigations or Area Quality Review Team (AQRT) meetings, identify opportunities for continuous improvements and prepare formal recommendations to ALIM leadership when appropriate.Retrieving documents and/or generating reports in response to queries from Regulatory Agencies (e.g. inspections) or Assistant General Counsel (e.g. product litigation cases related to Labeling in distribution).

However, incumbents may be tapped to represent ALIM on various cross-functional projects or sometimes lead ALIM continuous improvement teams. This could involve coordination of activities of other ALIM staff or contractors for the duration of the project.

Job Responsibilities

Liaises with markets and stakeholders to gather all necessary information to initiate and “build” PARs (according to local or regional requirements) to enable plant production of Labeling Artwork with minimal rework and to meet implementation requirements.
 

Creates Editor’s Copy (EC) for select markets depending on language(s) involved and specific “custom” services negotiated with markets in line with local SOPs.
 

Liaises with GRO GLM/ILG functions, GRS PCOs and PGS AWCs, or demand management lines to coordinate any unique factors that need to be considered; documents agreement on Artwork timelines across stakeholders; escalates any issues/concerns within ALIM functional line and/or relevant leadership for adjudication as necessary.
 

Performs ePALMS “Market Coordinator” role, according to agreed timelines and established procedures, by performing the following activities, which include:

Evaluates content of labeling updates and raises potential issues with GRS, PGS or relevant local markets as appropriate to minimize impact on schedules.Evaluates PGS sites impacted by labeling updates.Initiates PARs in collaboration with assigned market(s); ensures attributes (system metadata) are correct, and ensures 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 EC or as a separate EC for each market according to regional agreements and relevant job aids.Uses Biopharmaceutical Packaging & Artwork knowledge, in combination with Trade Dress Style Guides, Country Specific Requirements and/or other appropriate guidelines while collaborating with PGS AWCs to assure accurate packaging component ECs; escalates issues or concerns if/as neededSends PARs to all relevant PGS sites; monitors and follows up on any aging PARs as needed.Upon receipt of final draft Artwork, reviews proofreading report and resolves any technical formatting questions or errors; assures necessary proofreading of final printed artwork against EC is completed 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.Identifies appropriate Market Approvers for Packaging Artwork and electronically routes for approval using ePALMS lifecycle management; monitors progress and follows up as needed with appropriate PGS AWCs or GRS PCOs to assure agreed timelines are met and any Regulatory content issues that arise during the approval process are addressed.Tracks and communicates final approved labeling to list of relevant departments and stakeholders following final market review and signoff.Uploads any locally reconditioned or repackaged Artworks into ePALMS using “dual role” system capabilities to assure correct Artworks are available for next revision cycle.Leads teams in development and revisions of relevant SOPs for functional area.Works with minimal direct supervision; provides training and support to other team members or external vendors as required.Oversees work of other internal temporary personnel or external vendor staff as needed; tracks progress, monitors deliverables 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/or advises teams in responding to new or revised legislation, regulations or guidelines for assigned market or region.

Qualifications / Skills  

Demonstrated previous experience with:

Document management tools used for storage, retrieval, lifecycle management and tracking, of Labeling related secondary packaging components (e.g. ePALMS, GLAMS, BLUE, GDMS, Agile, PfLEET or similar systems).

Business Analytic tools used for tracking and reporting of product Labeling, Artwork or submissions (e.g. Business Objects, Spotfire, Tableau, Business Objects or similar reporting tools).

Document review, copy editing or proofreading tools (e.g. Docu-Proof, TVT or similar tools).

Some exposure to project management tools and processes (e.g. MS Project, Business Charters, Quad Charts, RACI, etc.)

Knowledge of external labeling guidelines and regulations and internal labeling policies and procedures.

Understand regulatory implications of product strategy with regards to the product label, assessment, and practical management of associated impacts.

Working in an international role with broad exposure to different regulations and cultures.

Education & Experience:

Manager Level: Bachelor’s degree in an appropriate discipline, plus 6–8 years related work experience (at least 2-3 years of which are preferred to have been in a Labeling Artwork Change Control & Implementation Management capacity or in roles such as Regulatory Strategy, Demand Management, Quality Operations or Supply Chain capacity which have frequent interactions with ALIM related specifically to Artwork Change
Control and Implementation.

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

Additional Qualifications/Attributes:

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.

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

Solid PC business software skills including document authoring, spreadsheet, database management, and presentation applications are required.

Strong written and verbal communication skills required

Strong English language skills are required of non-native English-speaking colleague to enable global interactions.

Must have multi-lingual skills.

Must be able to work under pressure of tight timelines, apply sound judgment in ambiguous business situations, appropriately assess issues for potential impacts and ability to escalate if/as needed.

Strong demonstrated project management and organizational skills.

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

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

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

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

Organizational Relationships:

This is a project management and troubleshooting role that Liases between local Pfizer Markets and relevant Manufacturing Plants or AWCs to assure timely implementation of artworks for labeling on packaging components according to local Regulatory Agency requirements.

Colleague coordinates Artwork Change Control workflows for assigned products, markets and vendors. In this role colleague also negotiates Artwork Implementation requirements across clusters of markets with conflicting requirements and may sometimes work across regions.

Colleagues liaise between key Packaging and Labeling Artwork stakeholders such as Global Regulatory Affairs (GRA), Global Labeling Management (GLM), International Labeling Group (ILG), Pfizer Global Supply (PGS) plants as well as relevant PGS Demand Management functions to coordinate. They often take the lead in negotiating Regulatory timelines for Artwork Implementation on Product Labeling and associated packaging components, taking into account conflicting drivers across markets and/or
stakeholders to assure Regulatory requirements are met and product supply is not impacted.

This role is an individual contributor and as such, has no direct reports or budget/cost center management responsibility.

Work Location Assignment: Hybrid

Purpose 

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!

Equal Employment Opportunity 

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!

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Regulatory Affairs