We're in relentless pursuit of breakthroughs that change patients' lives. We innovate every day to make the world a healthier place.
To fully realize Pfizer's purpose – Breakthroughs that change patients' lives – we have established a clear set of expectations regarding "what" we need to achieve for patients and "how" we will go about achieving those goals.
Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.
The Senior Manager, Global Labeling Lead (GLL) has overall accountability for the development and execution of global labeling strategy for their assigned products. This includes managing the end-to-end process of Target Labeling in early development, creation and maintenance of Core Data Sheets (CDS), and submission and label negotiations for US Prescribing Information (USPI), and EU Summary of Product Characteristics (EU SmPC). This role offers high visibility and the opportunity to work cross-functionally with SMEs, contribute to organizational strategic initiatives, and support Pfizer's Oncology pipeline. The successful candidate should possess an eagerness to grow, an aptitude for strategic thinking, and a focus on delivering for patients.
Role Responsibilities Lead the development, maintenance, and implementation of high quality labeling including CDS, USPIs, EU SmPCs, and patient labelingAuthor labeling content de novo based on scientific source data, understanding of regulations and guidance, and label precedentManage cross-functional Labeling Team and collaborate with stakeholders including Clinical, Medical, Safety, Regulatory, and CommercialDrive global labeling strategy through development of target labeling, scenario planning, and risk mitigationManage label negotiations with US FDA and EMAProvide guidance on labeling regulations, industry best practices, and competitor label assessmentsAct as the primary labeling representative on Global Regulatory Strategy Teams, Submission Working Groups, and other relevant product teamsContribute to strategic initiatives and process improvements across the organizationQualifications: Bachelor's degree in a scientific or technical disciplineMinimum of 8 years of relevant labeling experience in the pharmaceutical or biotech industryAdvanced knowledge of external labeling guidelines and regulationsAbility to successfully understand regulatory implications of product strategy with regards to the product label, assessment and practical management of associated impacts.Ability to develop strong and positive working relationships with cross-functional stakeholders and SMEsExcellent written and verbal communication skills; complete fluency in English languageProven strength in logical, analytical and writing abilityStrong project management skills and attention to detailProven ability to negotiate, influence and problem solveOncology experience strongly preferredWork Location Assignment: This is a HYBRID role, requiring an average of 3 days onsite. Candidate must be within 50 miles of a Pfizer site (PA, IL, NY).
The annual base salary for this position ranges from $117,300.00 to $195,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 17.5% 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.
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.
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