Senior Manager, Global Labeling Lead
Pfizer Inc.
South San Francisco, CA
Job posting number: #7290021 (Ref:pf-4923007)
Posted: October 28, 2024
Job Description
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 Labelingin 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 labeling
- Author labeling content de novo based on scientific source data, understanding of regulations and guidance, and label precedent
- Manage cross-functional Labeling Team and collaborate with stakeholders including Clinical, Medical, Safety, Regulatory, and Commercial
- Drive global labeling strategy through development of target labeling, scenario planning, and risk mitigation
- Manage label negotiations with US FDA and EMA
- Provide guidance on labeling regulations, industry best practices, and competitor label assessments
- Act as the primary labeling representative on Global Regulatory Strategy Teams, Submission Working Groups, and other relevant product teams
- Contribute to strategic initiatives and process improvements across the organization
Qualifications:
- Bachelor’s degree in a scientific or technical discipline
- Minimum of 8 yearsof relevant labeling experience in the pharmaceutical or biotech industry
- Advanced knowledge of external labeling guidelines and regulations
- Ability 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 SMEs
- Excellent written and verbal communication skills; complete fluency in English language
- Proven strength in logical, analytical and writing ability
- Strong project management skills and attention to detail
- Proven ability to negotiate, influence and problem solve
- Oncology experience strongly preferred
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Work Location Assignment: This is a HYBRID role, requiring average 3 days onsite. Candidate must be within 50 miles of a Pfizer site (WA-SEATTLE, CA-SFO, CA-San Diego)
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
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. This position requires permanent work authorization in the United States.
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.
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