Content Management Analyst

Collabera • Peapack and Gladstone, NJ

9d

About The Position

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 LEA 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. This role is responsible for initiation of Pfizer LEA 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 final 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 is also responsible for ensuring all packaging components are approved within Legal Entity alignment timelines. 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.

Requirements

• Bachelor’s degree in an appropriate discipline or closely related work experience.
• Ideally a recognized Project Management accreditation (or similar experience related)
• Must have lead cross-functional project management teams
• Must be familiar with working in a Regulated healthcare environment, ideally in the pharmaceutical industry.
• Experience in the processes associated with packaging, manufacturing, and distribution processes and a basic understanding of artwork & labeling regulations and controls.
• Must be able to skilfully interact with cross-functional stakeholder teams to lead and influence outcomes.
• Strong skills in MS Office applications.
• Strong communication and presentation skills are required.
• Capable of working under pressure and to tight timelines, applying judgment in ambiguous situations and appropriately escalate issues/potential impacts
• Must have high levels of organizational skills
• Attention to detail and ability to research and respond to audit/inspection queries
• Must be able to proof read/ copy check artwork if required.

Nice To Haves

• Higher levels of knowledge of manufacturing and site processes/requirements would be an advantage.

Responsibilities

• implementation of LEA new or revised secondary packaging components and/or labeling artwork for Biopharmaceutical products for assigned markets or groups of markets
• 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
• initiation of Pfizer LEA 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
• coordinating the change control logistics for implementation of final printed labeling content into secondary packaging components
• ensuring all packaging components are approved within Legal Entity alignment timelines
• track or report on KPIs (e.g. volume, timelines, and/or quality metrics) if requested

Benefits

• Collabera offers a full range of benefits to its employees including paid vacations, holidays, personal days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance, Disability Insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level