Posted:
8/20/2024, 5:00:00 PM
Location(s):
New York, New York, United States ⋅ Tampa, Florida, United States ⋅ California, United States ⋅ Florida, United States ⋅ Washington, United States ⋅ New York, United States ⋅ Lake Forest, Illinois, United States ⋅ Illinois, United States ⋅ Louisiana, United States ⋅ Groton, Connecticut, United States ⋅ Québec City, Quebec, Canada ⋅ Bothell, Washington, United States ⋅ Quebec, Canada ⋅ Connecticut, United States
Experience Level(s):
Mid Level ⋅ Senior
Field(s):
Operations & Logistics
The Labeling Operations Manager (LOM) provides operational support for the initial creation and relevant updates to labeling documents including the Core Data Sheets (CDS), United States Package Inserts (USPI), Summary of Product Characteristics (SPC) for products registered in the EU via the Centralized, Mutual Recognition or Decentralized
Procedures, and their associated Patient Labeling Documents. The Labeling Operations Manager, Manager is capable of managing a large volume of projects which can be highly complex.
The LOM will be knowledgeable of labeling guidance and policies related to technical/formatting (e.g. QRD template, PLR format) and will raise awareness of important factors to consider when revising the label.
The LOM provides project management to the Labeling Team throughout the labeling review and approval process through notification to stakeholders in order to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements. This includes setting clear targets, ensuring that Labeling Teams are aware of the review and approval timelines and following up with Labeling Team members
throughout the process as appropriate so that deliverables remain on target to meet internal and external deadlines.
Education:
Bachelor’s degree in a science or life sciences preferred or equivalent practical experience.
Experience and Attributes:
4-6 years experience in a regulated environment; pharmaceutical labeling experience required.
Knowledge of global/regional regulatory guidelines and requirements important.
Excellent written and verbal communication skills essential.
Complete fluency in English Language.
Proven strength in logical, analytical and writing ability essential.
Demonstrated project management skills and attention to detail required.
Identifies and resolves problems in a proactive manner.
Project Management capability and organizational skills:
Ability to assess and manage project timelines.
Ability to multi-task, prioritize and manage multiple projects.
Ability to identify and resolve problems in a proactive manner.
Demonstrates appropriate decision making including issue escalation to the Global Labeling Lead (GLL) and other appropriate stakeholders.
Interpersonal and communication skills:
Ability to liaise with stakeholders using effective means of communication. Clear and effective written and verbal communication skills.
Technical Skills:
Ability to apply labeling regulatory guidance on formatting requirements.
High attention to detail.
Ability to consolidate comments from multiple sources (e.g., emails, meeting minutes).
Systems and Document compilation skills, including:
Must have excellent computer skills and be proficient with Microsoft Word and similar applications.
Prepare submission ready documents.
Hyperlinking, pagination, Table of Contents (TOC) creation, etc.
Knowledge of Labeling and Document Management systems.
Work Location Assignment: On premise
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.
Website: https://www.pfizer.com/
Headquarter Location: New York, New York, United States
Employee Count: 10001+
Year Founded: 1849
IPO Status: Public
Last Funding Type: Post-IPO Debt
Industries: Biotechnology ⋅ Health Care ⋅ Medical ⋅ Pharmaceutical ⋅ Precision Medicine