Senior Manager, Global Labeling Lead

8+ years

$117,300 - $195,500 per annum

Bothell La Jolla South San Francisco

10 Nov. 23, 2024

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Senior Manager, Global Labeling Lead (GLL)

Join Pfizer as a Senior Manager, Global Labeling Lead to shape and execute global labeling strategies for our innovative products. This high-visibility role involves leading end-to-end labeling processes, managing cross-functional teams, and contributing to Pfizer’s Oncology pipeline while making an impact for patients worldwide.

Key Responsibilities:

Lead the development and maintenance of high-quality labeling, including Core Data Sheets (CDS), USPIs, EU SmPCs, and patient labeling.
Author labeling content based on scientific data, regulatory guidelines, and industry precedents.
Manage cross-functional Labeling Teams, collaborating with stakeholders across Clinical, Medical, Safety, Regulatory, and Commercial teams.
Drive global labeling strategy through target labeling, scenario planning, and risk mitigation.
Negotiate product labels with the FDA and EMA.
Provide expertise on labeling regulations, competitor assessments, and industry practices.
Represent labeling in Global Regulatory Strategy Teams, Submission Working Groups, and other product teams.
Contribute to strategic initiatives and process improvements.

Basic Qualifications:

Bachelor’s degree in a scientific or technical discipline.
Minimum of 8 years of relevant labeling experience in the pharmaceutical or biotech industry.
Advanced knowledge of external labeling guidelines and regulations.
Ability to assess regulatory implications of product strategies and manage labeling impacts.

Preferred Qualifications:

Oncology experience is highly preferred.
Proven ability to collaborate effectively with cross-functional teams and subject matter experts.
Strong analytical, writing, and communication skills.
Exceptional project management, negotiation, and problem-solving abilities.

Work Location:

Hybrid role requiring an average of 3 days onsite.
Candidate must be within 50 miles of a Pfizer site (e.g., PA, IL, NY).

Compensation and Benefits:

Base salary: $117,300 - $195,500 annually.
Bonus target: 17.5% of the base salary through Pfizer’s Global Performance Plan.
Eligibility for the long-term incentive program.
Comprehensive benefits package:
- 401(k) plan with Pfizer Matching Contributions and additional Pfizer Retirement Savings Contributions.
- Paid vacation, holidays, and caregiver/parental leave.
- Medical, dental, vision, and prescription drug coverage.
Relocation assistance may be available based on business needs and eligibility.

Learn more about Pfizer’s benefits at Pfizer Candidate Site – U.S. Benefits.

Compliance and Transparency:

Complies with federal and state regulations, including the Sunshine Act for licensed physicians’ expense reporting.

EEO & Employment Eligibility:

Pfizer is committed to equal employment opportunities for all individuals, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, age, national origin, disability, or veteran status.

Apply today to advance your career in a dynamic, supportive environment, and help shape the future of global health.

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Senior Manager, Global Labeling Lead

Job Description

Key Responsibilities:

Basic Qualifications:

Preferred Qualifications:

Work Location:

Compensation and Benefits:

Compliance and Transparency:

EEO & Employment Eligibility:

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