The 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
- Manage 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 5 years of relevant experience in the pharmaceutical or biotech industry
- 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 preferred
Work Location Assignment: Hybrid
The annual base salary for this position ranges from $99,900.00 to $166,500.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% 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
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.
Regulatory Affairs#LI-PFE
