5 days old

Packaging and Labeling Artwork Implementation Specialist

Peapack, New Jersey
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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 Editor's Copy (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.


**Demonstrated previous experience with:**

+ Pharmaceutical labeling experience.

+ Regulatory labeling experience preferred.

+ Packaging experience or familiarity.

+ 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.

**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.

Last Date to Apply for Job: June 21st, 2021.

Eligible for Relocation Package: NO

Eligible for Employee Referral Bonus: YES


**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Posted: 2021-06-11 Expires: 2021-07-12
Sponsored by:
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Packaging and Labeling Artwork Implementation Specialist

Peapack, New Jersey

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