Job summary
- The ILA Team Lead (TL) role is accountable for overseeing the day-to-day work of a team of Hub Labeling Managers (HLMs) and Market Coordinators (MCs). HLMs and MCs may be assigned specific markets or products within a region, or will support the region as a whole. The TL role reports to the respective ILA Regional Head.
- The TL is a subject matter expert for local/regional artwork and labeling, and acts as a resource to the ILA Regional Head and other HLMs and MC throughout the organisation, leading others in complex projects or initiatives, and contributing to the use and development of current and new tools, technologies and processes to support global labeling and artwork development, submission, approval, and implementation.
- The TL supervises and prioritises the work of:
- Assigned HLMs who manage production of Local Product Documents (LPDs), Local Language Documents (LLDs) and Patient Leaflets according to company policies and SOPs, and meet monthly compliance targets. The TL may also manage label updates themselves according to business need when required.
- Assigned MCs who work in Pfizer’s Enterprise Artwork & Labeling Management System (ePALMS) to process Pfizer Artwork Requests (PARs) in an “above country” hub model. This also involves oversight of activities associated with shared packaging across multiple markets or regions. The TL may also perform the MC role according to business need when required.
- Contribution to regional global knowledge resources is also a key part of the role, and the TL is proactive in gathering, assessing and disseminating regulatory intelligence for use by HLMs and MCs, as well as for use in strategic decision-making at the global group level.
Job responsibilities:
- Provides management and oversight of assigned staff, setting objectives in line with GLAAM and ILA goals
- Meets strategic targets for deliverables as defined for the function, and communicates progress against these targets and issues which could impact meeting these targets, including proposed remediation.
- Acts as the key escalation point with IRS Regulatory Cluster Heads or delegates when a labeling or artwork-related issue cannot be resolved by the assigned HLM/MC. Liaises with Labeling or Artwork SMEs to resolve complex issues and escalates to the ILA Regional Head when needed.
- Mentors, trains or supervises assigned HLMs and MCs in their day-to-day activities, reviewing their work where needed and providing expert advice on labeling and artwork content, formatting and process adherence.
- According to business need, utilizes regulatory expertise to review, develop and deliver core labeling documents such as the LPD and Patient Leaflet to support submissions to the Regulatory Authorities across regions, requesting medical advice or input from others when appropriate. The full range of labeling documentation may be produced, including labels for NCEs or Product Line Extensions, as well as complex revisions.
- May support responses to queries from Pfizer colleagues in response to inspection activities and regulatory agencies
- Assures that Pfizer’s Biopharmaceutical portfolio complies with Regulatory and Commercial quality standards and Pfizer Trade Dress across assigned clusters of Markets/Products.
- Ensures that assigned staff monitor changes to relevant national Labeling and Artwork regulations and that processes exist to advise and/or consult with Global Regulatory Sciences (GRS), Pfizer Global Supply (PGS) and Plant/Artwork Center (AWC) colleagues as needed to assure local and/or regional processes and documents (1) meet ongoing standards of quality, (2) adhere to Regulatory Compliance requirements and (3) will stand up to audit/inspection scrutiny.
- Accountable for assuring staff compliance with monitoring “aging PARs” and that Market colleagues in International Regulatory Strategy (IRS) have transparency to status of final local printed labeling, which meets local Regulatory definitions of “Implementation”. Ensures product launch priorities are followed and project milestones are met by their team.
- Accountable for compliance with global systems/processes used in Labeling & Artwork development and change management (e.g. ePALMS, PfLEET) to assure quality and integrity of information implemented into final Local labeling documents and printed labeling is maintained.
- Coordinates complex labeling activities when there is a regional, global or therapeutic area impact across multiple countries.
- May lead regional SME forums on labeling and artwork processes and clearly articulates expectations of the process to a broad range of stakeholders. May represent the function or region on project improvement initiatives.
- Interprets internal/external business challenges and best practices to recommend improvements to products, processes, or services.
- May be appointed as a focal point within a Hub to lead compliance monitoring initiatives – alerting HLMs and MCs to specific items that need to be addressed and as the point of contact to investigate and escalate broader issues to the appropriate contact (eg GLAAM Compliance and Process Quality functions).
- Provide ILA representation for support during market audits and assistance in remediation proposals and activities. May also represent ILA on Area Quality Review Team (AQRT) meetings; investigates and documents root cause analyses; takes a leadership role in addressing findings that impact team; makes recommendation on action plans and future risk mitigation strategies.
- In collaboration with MCs and HLMs, may represent team on Supply Chain/Demand Management issues and negotiates with PGS in collaboration with IRS colleagues as needed to prevent drug shortages.
- Collaborates with IRS and PGS AWCs to ensure accurate and timely progression of workflows; follows up as needed to assure PCO transparency into “Artwork Implementation” for revised labeling & packaging component Artwork as define by local regulatory agencies under the guidance of International Regulatory Strategy (IRS)
- Fosters strong relationships with ILA team’s customers (Regulatory, Medical, PGS, Supply Chain, Demand Management, PCOs, Commercial and Legal) via regular communications and presentations, as needed.
- May evaluate and implement new Artwork and Labeling technologies in close collaboration with common stakeholders
- May represent ILA and Pfizer on artwork and labeling topics in external forums, eg trade associations, conferences and other external policy engagement activities
Note: In addition to operational oversight of direct reports, colleagues in this role will also periodically step in and perform the same day-to-day activities, depending on workload and capacity within their team
Qualifications/Skills:
- Leadership and motivational skills
- Excellent interpersonal skills to keep the team focused and on track for meeting their deliverables
- Comprehensive knowledge of the principles, concepts and theories of the labeling and artwork disciplines, and good understanding/ knowledge of principles and concepts of other related disciplines.
- Solid understanding of regulations as they relate to all aspects of finished goods labeling, as well as import/export requirements, for relevant markets.
- Proficient in use of systems consistent with business expectations, and understands importance of systems in maintaining target compliance figures
- Fluency in English language important however multi-language skills are advantageous
- Clear and effective written and verbal communications
- Understanding of the importance of Standard Operating Procedures (SOPs), systems and processes in underpinning quality and compliance of deliverables
Education:
Life sciences, pharmacy graduate or equivalent.
- Advanced academic qualifications/degree such as PhD an advantage but not essential.
Experience
- Direct management experience is preferred.
- Extensive ‘Hands on’ registration experience associated with development, maintenance and commercialization activities within Regulatory Sciences (Human Medicinal Products); preferably from the perspective of a Country office or Regional Regulatory Strategy important and advantageous especially with the perspective of the implications of a CDS on CLDs, and/or experience in managing artwork workflows and systems
- Proven ability to successfully understand regulatory implications of product strategy with regard to the product labeling and artwork, assessment and practical management of associated impacts.
- Demonstrated ability to develop strong and positive working relationships across multiple cultures
- Knowledge of global/regional regulatory guidelines and requirements important
- Knowledge of regulatory procedures, e.g. Safety Variations, preferred
- Knowledge of artwork creation, graphic design, manufacturing supply chain management or packaging engineering is desirable
- Proven strength in logical, analytical and writing ability essential
- Demonstrated project management, attention to detail and problem solving skills required.
Organizational relationships
This position reports to the respective ILA Regional Head.
Other key interfaces include IRS Regulatory Cluster Heads and delegates, Execution Hub Team Leads, PGS Site Leaders, PGS Quality Operations, regional and local Medical contacts, Regulatory Innovation, Excellence and Data Governance (RIDGE), above country regulatory strategy and customer/stakeholder groups in Above-Country labeling functions and GLAAM.
Resources managed:
May typically manage 4-12 resources as required
Work Location Assignment: Hybrid
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.
DisAbility 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!
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Regulatory Affairs
