Head, International Product Labeling & Commercial Artwork

ROLE SUMMARY:

This role is responsible for setting the strategic vision for the International Labeling & Artwork function (approximately 175 resources) within GRS and taking all actions necessary to ensure successful execution of the vision. This includes ensuring the creation and maintenance of product labels and related artwork components for all products within Pfizer’s International markets. This leader plays a crucial role in ensuring the construction of roles within the international labeling & artwork function upholds & prioritizes compliance with internal SOPs & policies, systems, adherence to worldwide regulations, and meeting or exceeding compliance targets and related KPIs.   

This role is accountable for designing, developing and maintaining an optimal operating model for the international labeling and artwork function and liaises with stakeholders to ensure alignment of the model with International Regulatory Strategy, Above Country labeling & regulatory strategy, Regulatory International Operations, PGS, commercial and other key partners.   

Underpinned by the strategic vision, this role establishes & socializes the International Labeling & Artwork functions’ overall objectives, provides clarity on semester/yearly goals and clearly prioritizes projects that meet GRS, CMO and the broader Pfizer business needs related to product labeling and commercial artwork. This role requires sustained knowledge of other function’s priorities and the broader CMO/R&D priority projects such as digital/technology, data, process improvement projects and external influencing efforts. 

This role is accountable for responding swiftly and effectively to changes in GRS, CMO or enterprise strategic directions and ensuring proper execution that allows realignment to changing business needs. This role identifies and capitalizes on new ideas, technologies and opportunities and immediately addresses & mitigates high risk areas with speed and precision. 

This role works with their direct report regional leaders to ensure:

• Optimized utilization of resources aligned to operating model and business priorities.

• Successful execution of related regulatory requirements for all product deliverables within Pfizer’s portfolio.   

• Timely & effective communications and information sharing within the function, with key partners, and across R&D org stakeholders.

• Effective planning, development and execution of colleague onboarding, training, and upskilling. 

• Effective plans and initiatives in place that allow continuous colleague growth and development.

ROLE RESPONSIBILITIES:

• Defines and articulates the overall function’s vision and oversee leadership and strategic direction for the international product labeling and commercial artwork organization.

• Drives necessary development and ongoing adjustments to roles, processes and systems involved in the international labeling & commercial artwork domain.  

• Directs international product labeling & commercial artwork colleagues to ensure delivery of high quality, timely & compliant deliverables across the Pfizer portfolio.  

• Mentors & coaches direct reports and colleagues within function to ensure succession planning, talent development, and key performance management.

• Provides matrix leadership across GRS (and beyond) for large strategic labeling and artwork initiatives and/or technology programs as needed.

• Ensures adequate coverage for process and documentation of standards, which assures that worldwide regulatory requirements are met and ensuring worldwide consistency as much as possible.    

• Proactively works to drive collaboration, partnership, transparency, and interoperability of systems/processes across GRS, especially with IRS, RIO, & Category Reg Strategy, and Strategic Labeling, as well as PGS to drive greater efficiency and reduced costs.

• Facilitate leadership decision making that ensures full support and coverage for internal/external audits and GVP and GCP inspections. 

• Provides SME and ensures oversight for vendors/contractors.  Work closing with Business Operations and Finance to ensure contracts, training, resources and processes are appropriately monitored. 

BASIC QUALIFICATIONS:

• Masters degree or higher in a scientific field, e.g. PhD, MS, Pharm.D., etc. and at least 10 years’ experience in the following areas within the pharmaceutical industry, a regulatory agency or academia - drug development, regulatory affairs, pharmacovigilance, quality management, clinical, and/or continuous improvement.

• In-depth understanding of the