at Pfizer, Inc in Bentonville, Arkansas, United States
Job Summary: The Labeling Cluster Head Director has accountability for ensuring labeling project management and labeling strategy is provided to Pfizer labeling teams/RMCs. Ensures labeling expertise is provided to assigned Therapeutic Areas/Business Units for label content and placement, regulation guidance and project management resulting in the production of high quality and timely CDS, USPIs and EU CP/MRP/DCP SmPCs. As appropriate, this role will represent on global, local, or divisional activities. This role provides prioritization and coordination of all cross-functional activities related to processes and/or labeling content that support labeling development and as necessary will present global project plans to Labeling Governance boards. This role has leadership and supervisory responsibilities for Global Labeling Leads (GLLs) and may include oversight of the performance of vendors and contractors. This role maintains a keen focus on colleague development, mentoring, building leadership capabilities, recruiting and retaining key talent, and performance management. Creating an encouraging, supportive and highly productive accountable work environment. As necessary reviews, evaluates and assesses product labeling updates to ensure consistency with RA regulations, CMCDs, and best practices. When appropriate, assesses and advises on locally driven content inconsistencies. Is accountable for ensuring appropriate monitoring and interpretation of regulatory guidance, directives and RA regulations to assure consistent application across product lines, therapeutic areas and Business Units. This role is also responsible for making recommendations to ensure consistency and uniformity in the approach to labeling across the organization. This role works closely with colleagues in Regulatory, Safety, GRO, Clinical, DSRD, and others as necessary to understand issues of mutual interest so that effective labeling support model and processes can be developed and maintained. Collaborates with other Labeling Cluster Heads to ensure consistency of labeling concept application, strategies and process application across Pfizer. This role has accountability for project and staff allocation forecasting, milestone tracking and the application of resources to fully support above country labeling needs across the portfolio.
Primary responsibilities critical to the job.
* Manages and provides ongoing guidance and mentoring to GLL's as necessary to ensure staff can satisfactorily fulfill their job roles.
* Plans and implements ways to enable staff to remain knowledgeable and up to date regarding external labeling requirements.
Utilize labeling expertise and regulatory knowledge to oversee and provide sound guidance to GLLs and Labeling Team members.
* Engages with stakeholders across the organization to ensure that actions taken follow applicable controlled documents and result in high quality, timely outputs that maintain labeling compliance.
* Assures adequate project management and labeling strategy is provided consistently across the organization.
* Liaises with safety and regulatory intelligence to contribute to Pfizer responses to draft BoH regulations and guidance.
* Enforces use of standards and best practices for execution of labeling projects.
* Serves as primary point of contact for audits, inspections 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.
* Addresses labeling team conflicts or escalating issues that have implications across the BU/portfolio. Resolves or escalates to designated governance/executive committees if discussions cannot be resolved within the team.
* May act to facilitate changes to governing CMCDs and provides review and comment on other related CMCDs that impact labeling.
* Acts as primary liaison with labeling and safety governance bodies (e.g., LEC) and when necessary, act as the Labeling SME from Pfizer at industry working groups/conferences.
* May lead labeling related change management projects across the organization.
QUALIFICATIONS / SKILLS
* Life sciences, pharmacy graduate or equivalent
* Advanced academic qualifications (e.g. MS, MBA, PhD, and PharmD) desirable.... For full info follow application link.
EEO & Employment Eligibility:
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.