The Labeling Cluster Head Senior Director has accountability for ensuring that labeling strategy, labeling project management and overall labeling operations is provided to Pfizer Labeling teams and Risk management committees. This role ensures labeling expertise is provided (to designated Therapeutic Areas/Business Units and across multiple Business Units) for the development and maintenance of label content and placement, regulation guidance and labeling management resulting in the production of high quality and timely CDS/CSIs, USPIs and EU CP/MRP/DCP SmPCs. In doing so, this role has leadership and supervisory responsibilities for Global Labeling Leads which may also include oversight of the performance of vendor relationships and contractors. Accountability includes project and staff allocation forecasting, milestone tracking and the application of resources to fully support competing needs across the portfolio. This role maintains a keen focus on staff colleague development, building leadership capabilities, recruiting and retaining key talent, performance management, and creating a supportive and highly productive accountable work environment.
This role also influences Asset Teams and Sr. Management on labeling strategy by advising on the overall labeling development approach and timelines. Influencing labeling content to enhance viability, ensuring consistency with RA regulations & expectations, alignment with corporate policies, CMCDs & and overall internal guidances. Through many different mechanisms, this role plays a vital role in ensuring consistency of application and uniformity in approach to labeling across product lines, therapeutic areas and Business Units.
This role has a wide network of stakeholder management and collaborations aimed at ensuring mutual understanding and mutual interest so that effective labeling support model and processes can be developed and maintained. This role acts as a business process owner for a given process or CMCD and may have overall responsibilities related to coordinating, supporting and preparing for audits and/or inspections. This role will represent Global Labeling on global, local, or divisional activities and routinely engages/influence the external environment on labeling related areas of expertise.ROLE RESPONSIBILITIES
Indicate the primary responsibilities critical to the job.
- Assures labeling strategy, labeling project management and operational excellence is provided consistently within assigned therapeutic areas and across the organization.
- Utilizing strategic and operational labeling and regulatory knowledge expertise, provides guidance within GRO as well as to stakeholders outside GRO (including Safety Strategy, Regulatory Strategy, Medical, Labeling Executive Committee, etc.) Decisions have long-term business unit/ functional impact or regulatory impact and may entail risk or business opportunity.
- Manages and provides ongoing guidance and mentoring to GLLs as necessary on strategic and technical expertise to ensure staff can fulfill their job roles. Develops direct reports' leadership, negotiations and communication skills and guide GLLs on acceptable levels of risk-taking.
- Plans and implements ways to enable staff to remain knowledgeable and up to date on external labeling requirements, pending regulations and industry trends.
- Recognized internally and may be viewed externally as an expert in Labeling Strategy; leverages their expertise across larger (e.g., multiple category domains or several business units) business segments or functions.
- Provides oversight of vendors and contractors utilizing resources outside direct authority and may manage overall vendor relationship and corresponding financial responsibilities/resources within business line.
QUALIFICATIONS / SKILLS
- Lead teams that set strategic direction for Pfizer labeling and establish global/corporate policies and standards.
- 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 compliance.
- Lead the development of Pfizer responses to draft RA labeling regulations and guidance.
- Partner with Regulatory Strategy to develop proposals and/or draft communications to regulatory agencies, e.g., FDA on specific topics.
- Partnering and advising colleagues in the International Labeling Group and Pfizer Country Offices to align labeling approaches, e.g. content inconsistencies, policy implementation, etc. across Pfizer.
- Enforces use of standards and best practices for execution of labeling projects.
- Serves as primary point of contact for labeling audits and inspections (including pharmacovigiliance partner activities) and liaises with necessary counterparts in responding to regulatory agency queries.
- Analyzes quality and performance metrics in order to establish proper corrective action plans and risk mitigations. Establishes and continually evolves metrics in line with portfolio and business function expectations.
- Addresses labeling team conflicts or escalating issues that have implications across the BU/portfolio. Resolves or escalates to designated governance/executive committees as deemed appropriate.
- Facilitates or authors changes to governing CMCDs and leads the review and comment on other related CMCDs that impact labeling.
- Acts as primary liaison with labeling and safety governance bodies (e.g., LEC)
- Represent Pfizer labeling, leading or participating in industry working groups, panels, conferences etc.
- Serve as Labeling Executive Committee Chair delegate when necessary.
- Lead labeling change management and continuous improvements projects across R&D organizations, e.g., PIH and PEH.
- Champions innovative approaches and thoughtful risk-taking within labeling.
- Provides back up to the Head of Global Labeling Management and serves as group point of contact when necessary.
- Ensures labeling commitments occur as per documented in Pharmacovigilance Agreements (PVAs) within TA/Cluster scope of responsibility and manages the review and approval of PVAs ensuring consistency where necessary across the portfolio.
Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.Qualifications
- Life sciences, pharmacy graduate or equivalent
- Advanced academic qualifications (e.g. MS, MBA, PhD, and PharmD) highly desirable. Equivalent relevant professional experience will be considered.
- 12+ years' experience in global pharmaceutical environment with increased responsibilities, including direct experience in Labeling management and/or Regulatory Strategy dealing with health authorities.
- Significant 'hands on' Labeling experience associated with development, maintenance and commercialization activities.
- Proven understanding of the dynamics and purpose of company Core Data Sheets (CDS). Experience at the regional/ country level desirable.
- Experience in ability to function autonomously at senior levels and in a matrix team environment a must.
- Significant experience and knowledge of global/regional regulatory regulations and guidelines pertaining to labeling.
- Experience in interpreting and applying global and local regulatory guidance around labeling and associated supportive documentation required.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine Act
- Demonstrated ability to apply regulatory guidance and decipher/explain implications of label changes across multiple geographic regions.
- Demonstrated people management and mentoring skills with clear ability to provide global management to colleagues across sites and influence those outside their direct authority.
- Demonstrated leadership skills in creating and fostering supportive, accountable, and growth driven environment. Demonstrated teaching and coaching capabilities.
- Demonstrated stakeholder management and strong influencing and negotiating skills with cross functional teams and Sr. leadership.
- Demonstrated ability to analyze, think creatively, problem solve, and develop and articulate strategic plans.
- Proven ability to successfully understand global regulatory implications of product strategy with regard to the product labels within assigned therapeutic areas and across the portfolio.
- Demonstrated ability to exhibit sound judgment, leading through ambiguity and change.
- Proven accountability and demonstrated excellence in interpersonal communication, negotiation, and influencing capabilities. Clear establishment of positive working relationships across locations and functional lines.
- Demonstrated clear and effective written and verbal communications skills and is capable of interacting at all senior levels of the organization.
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