JOB SUMMARY
Colleague fundamentally performs the ePALMS system “Market Coordinator” role in close collaboration with the Global Regulatory Affairs (GRA) 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.
This role is responsible for:
- Initiation and “build” of Pfizer Artwork Requests (PARs) in collaboration with markets, assuring all required information, specifications and/or supportive documentation is available for plants/Artwork Centers to execute the production of product labeling related packaging components.
- Coordinating Artwork Change Control logistics across multiple Pfizer departments 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. Accountability for final label content rests with the PCOs or functions creating content.
- Support for large-scale Artwork Change Control projects with broad portfolio impact under the direction of more senior ALIM staff.
- Research into root cause assessments for internal ALIM Quality Investigations or Area Quality Review Team (AQRT) meetings and potential process improvement recommendations.
- Retrieve documents and/or generate 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).
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.May create 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/IL functions, GRA/PCOs and PGS PCOs, 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 (independently or with minimal supervision):
- Evaluates content of Labeling updates and raises potential issues with GRA, PGS or relevant local markets as appropriate to minimize impact on schedules.
- Evaluates PGS sites impacted by labeling updates.
- Initiates Pfizer Artwork Requests (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 needed.
- Sends 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 PCOs or GRA 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.
QUALIFICATIONS / SKILLSDemonstrated 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).
Education & Experience:
- Senior Associate Level: Bachelor’s degree in an appropriate discipline, plus 4-6 years work experience related to Artwork Change Control processes.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. Multi-lingual skills are highly desirable at all levels.
- 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.
- Demonstrate 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.
Work Location Assignment: Hybrid
EEO (Equal Employment Opportunity) & Employment Eligibility
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Regulatory Affairs