The Head of Strategic Labeling and Advertising & Promotion has overall accountability for ensuring the high quality and timely development, maintenance of Global Labeling documents (Core Data Sheet, USPI and EU SmPC) and Advertising and Promotion for Pfizer's drug and vaccine portfolio. Scope of accountability includes providing strategic guidance and recommendations to program teams and ensuring the development of innovative and competitive labeling strategy, and labeling project management is provided to Program Asset Teams, Governance, Pfizer Labeling teams and Risk management committees. 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. Responsible for creating an up-to date and accessible target product label to effectively and efficiently guide innovative development from Phase 1 through product lifecycle.
This position provides executive leadership to the strategic labeling department (up to ~40 colleagues) and Advertising & Promotion colleagues, establishing it's long term vision, developing strategies for execution & identifying emerging business needs to ensure readiness, compliance, and appropriate resolution of challenges and/or evolving requirements. Responsibilities include executing and maintaining an optimized operating model, managing the departmental budget, ensuring staff talent development, succession planning, career development and performance management. Working from phase 1 through lifecycle, this role will serve as a strategic partner with Chief Development Officers, Global Regulatory Strategists, and Category Leads.
This highly visible role has a wide network of stakeholder management and collaborations aimed at ensuring mutual understanding of regulations and regulatory precedents and mutual interest so that effective labeling support model and processes can be developed and maintained. This role will represent Global Labeling on global or divisional activities and routinely engages/influence the external environment on labeling related areas of expertise.JOB RESPONSIBILITIES
QUALIFICATIONS / SKILLS
- Ensures the high-quality delivery, maintenance, and ownership all labeling documents from Phase 1 through lifecycle , services and strategic guidance to the organization
- Provides strategic labeling guidance to program and asset teams to enable efficient competitive development of drugs and vaccines based on regulatory precedent, emerging data and competitive landscape
- 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
- Serves as strategic partner to BU heads, PRD, ORD and Biopharma
- Identify and optimize underlying processes and principles for developing labeling claims, sets strategic direction for Pfizer labeling organization and establish global/corporate policies and standards
- Ensures adherence to relevant policies and procedures and external regulatory requirements.
- Plans and implements ways to enable staff to remain knowledgeable and up to date on external labeling requirements, pending regulations, competitive intelligence, 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.
- 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.
- Partner with Regulatory Strategy to develop proposals and/or draft communications to regulatory agencies, e.g., FDA on specific topics.
- 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.
- Responsible for Labeling staff talent development, succession planning, career development and performance management to ensure that resources are appropriately attracted developed and deployed.
- Champions innovative approaches and thoughtful risk-taking within labeling.
- Partners with Clinical, Regulatory, Safety, Legal, Commercial and other leaders as appropriate to ensure alignment of priorities, strategies and key objectives.
- Collaborates with peers at other pharmaceuticals and global regulatory authorities as appropriate to maintain a leadership role in direction and development of regulations and guidance.
- Influences external environment in relation to areas of responsibility through participation in industry organization associations and working groups.
- B.S./B.Sc. in Pharmacy, Life Sciences or Information Technology required.
- MS/Ph.D. or other advanced academic qualification/degree is desired; equivalent relevant professional experience will be considered.
- 15+ years direct experience in managing global/multi-national regulatory function in the pharmaceutical environment.
- Proven success with managing global teams and effectively developing high performing teams and coaching colleagues to achieve their highest potential.
- Proven accountability, and demonstrated excellence in interpersonal, communication, negotiation, influencing, and problem-solving capabilities.
- Experience in monitoring and influencing external environment recommended.
- Demonstrated ability to successfully implement large-scale business process improvements and transformations.
- Demonstrated ability to exhibit sound judgment and deal with ambiguity and change.
- Project Management: Mastery of processes, tools and techniques for planning and monitoring multiple complex projects to established deadlines
- Strategically Adept: Analytical mindset to develop effective business and competitive strategies for dealing with current and future industry trends and internal organizational challenges. Global perspective within the context of the business needs and impacts
- Leadership: Exemplifies behaviors consistent with the company's leader's behaviors and values. Motivates peers and colleagues through example, commitment, loyalty, and enthusiasm
- Understanding Customer Needs: Considers customers, including regulatory agencies, clinical and safety, in developing strategies, and priorities for future business direction
- Networking and partnership building: Builds wide network of alliance with key customers and utilizes their input to drive strategic thinking and find collaborative partnerships
- Influencing: Uses a range of effective communication styles and creates an inclusive environment with internal/external stakeholders to deliver goals and promote quality. Uses diplomacy and tact and can diffuse high-tension situations comfortably
- Coaching and People Management: Provides direct, constructive, and actionable feedback to direct reports and staff within line. Provides adequate training and up-skill opportunities for staff.
- Change Management: Effectively implements procedures or makes decisions to deal with change. Copes with ambiguity in the business environment
The annual base salary for this position ranges from $254,400.00 to $424,100.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 30.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.Sunshine Act
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