Head of Global Labeling and U.S. Advertising & Promotion

JOB SUMMARY

Global Regulatory Sciences (GRS) serves as strategic leader and catalyst enabling high quality, efficient, innovative, label-focused global development that changes patient lives throughout the product life cycle.

The Head of Global Labeling and U.S. Advertising & Promotion has overall accountability for ensuring the high quality, timely development & maintenance of all labeling & commercial artworks for both Global (above-country labeling documents) and International (nationally approved labeling) documents, as well as US-based promotional materials. 

This function covers all aspects of the domain deliverables in scope, e.g. strategy, operations, execution, compliance and oversight including product Investigator’s Brochure, Company CDS, USPI, EU SmPC, local market prescribing information, all related patient-labeling documents, artwork & packaging materials, and all US-specific materials for drugs and vaccines in line with global and local regulatory requirements.   This role has overall accountability for ensuring proper oversight and compliance monitoring of activities within labeling, artwork and Ad Promo domain. 

This role is accountable for providing strategic guidance & recommendations to therapeutic program teams and ensuring the development of innovative and competitive labeling and promotional materials for all Pfizer assets.  This role plays a vital part in ensuring adherence to Pfizer labeling & US promotional policies including utilization of the Investigator’s Brochure and Company Pfizer Reference Label (PRL) and in driving procedures and governance decisions that ensure consistency of application and uniformity in approach taken by product teams. 

This role collaborates closely with enterprise stakeholders to ensure the creation of an up-to-date and effective target product label that guides the innovative development of Pfizer products.  Specifically, this role is accountable for driving and overseeing the development, maintenance & endorsement of North Star from origin to completion.  The role represents GRS in appropriate governance and risk management committees.    

This role will represent GRS & Pfizer on global or divisional activities and routinely engage/influence the external environment on related areas of expertise.  This position provides executive leadership and direction setting for the overall function, overseeing ~200+ colleagues, developing strategies for execution & identifying emerging business needs to ensure readiness, compliance, and appropriate resolution of challenges and/or evolving requirements.

JOB RESPONSIBILITIES

• Ensures the high-quality creation, maintenance, and execution of all labeling & artwork documents throughout product lifecycle.
• Provides strategic advertising and promotional guidance to program and asset teams to enable efficient competitive development of drugs and vaccines based on regulatory precedent, emerging data and competitive landscape.
• Ensures proper analysis of competitive landscapes and influences product teams to ensure availability of up-to-date therapeutic information.   
• Ensure staff can serve as strategic partners to TA Leads, BU heads, and Research & Development and Commercial Sr. leaders by providing effective strategic guidance to programs and asset teams such that competitive development of drugs & vaccines occurs
• Identify and optimize underlying processes and principles for developing strategic labeling claims, sets direction for Pfizer labeling & artwork organization, and establishes global/corporate policies. 
• Champion and implement the adoption of digital tools including artificial intelligence enhance decision-making, optimize workflows, drive innovation and efficiency
• Ensures adherence to relevant policies & procedures and external regulatory requirements.
• Plans and implements ways to enable staff to remain knowledgeable and up to date on labeling requirements, pending regulations, competitive intelligence, and industry trends.
• Ensures proper oversight is provided for vendors and contractors.  Strategically utilizes resources outside direct authority and is responsible for relevant financial obligations. 
• Engages with stakeholders across the organization to ensure that actions taken follow applicable regulations and Pfizer controlled documents and result in high quality, timely outputs that maintain labeling and AdPromo compliance.
• Ensure that proper analytics & insights are conducted on quality and performance metrics in order to establish proper corrective action plans and risk mitigations. Maintains an organization structure such that metrics continually evolve in line with portfolio and business function expectations.
• Maintains or