Artwork Implementation Manager - Bucharest

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Artwork Implementation Manager
Bucureşti
Bucharest, Bucharest, Romania

ROLE SUMMARY

Colleague will fulfil the “Market Coordinator” role in close collaboration with the Global Regulatory Science (GRS) functions at Pfizer Country Offices (PCOs) and is the central Regulatory point of contact for the Pfizer Global Supply (PGS) plants/Artwork Centres (AWC).  Colleague operates from a Subject Matter Expert (SME) centralised “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 an experienced “Market Coordinator” within the Artwork Management function these colleagues perform activities 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 departmental deliverables when required. Accountability for Final Label Content rests with the PCOs or functions creating content.

Research into root cause assessments for internal artwork Quality Investigations or meetings, identify opportunities for continuous improvements and prepare formal recommendations to artwork management 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).

Colleagues may be expected to represent Artwork and Launch Implementation Management (ALIM) on various
- 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.

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 Global Regulatory Operations, Global Label Management/International Labelling Group 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 artwork system “Market Coordinator” role, according to agreed timelines and established procedures, by performing the following activities:

Evaluates content of Labelling updates and raises potential issues with GRS, PGS or relevant local markets as appropriate to minimise impact on schedules.

Evaluates PGS sites impacted by Labelling 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 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 artwork lifecycle management system; 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 labelling to list of relevant departments and stakeholders following final market review and signoff.

Uploads any locally reconditioned or repackaged Artworks into artwork management system 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.

Work Location Assignment: On Premise (Sandwich or Walton Oaks, UK)(Romania, Bucharest)

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.

Dis
Ability Confident

We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!

Engineering#LI-PFE

Detalii privind locul de muncă:

Firma:	Pfizer
Localiția:	Bucureşti Bucharest, Bucharest, Romania
Adăugat:	9. 7. 2024 Postul de muncă activ

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Artwork Implementation Manager Bucharest

Artwork Implementation Manager
Bucureşti
Bucharest, Bucharest, Romania

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Artwork Implementation Manager Bucharest

Artwork Implementation ManagerBucureştiBucharest, Bucharest, Romania

Detalii privind locul de muncă:

Locuri de muncă noi pe e-mailul tău

Locuri de muncă Bucureşti - locuri de muncă interesante în împrejurimi:

Bucureşti: Alte locuri de muncă în orașul tău

Artwork Implementation Manager
Bucureşti
Bucharest, Bucharest, Romania