The Labeling Operations Manager, Senior Associate 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 LOM will be knowledgeable of labeling guidance and policies related to technical... more details
The Labeling Operations Manager, Senior Associate 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 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.
The LOM, Senior Associate will provide the following operational support:
Generate necessary renditions (e.g., clean and marked PDF, clean and marked MS Word) and bookmark renditions as appropriate.
Facilitate workflow through corporate document repository
Finalize documents post QC
Manage the document status in document management system and notify internal stakeholders of the availability of labeling documents.
Create and QC SPL (xml) for USPIs
Responsible for ensuring compliance to Company’s submission standards, policies and procedures. Ensure all actions taken within role follow applicable SOPs and associated documents so that high quality delivery of outputs and compliance is maintained. Ensure appropriate tracking of labeling projects via defined procedures and optimal use of systems.
Consolidate labeling versions.
Consolidate comments from Labeling reviewers and Regulatory Authorities.
Prepare comparison tables for labeling team discussions.
Edit and format labeling documents- Ensure the document complies with the appropriate template (e.g., QRD, PLR).
Update and maintain the CDS log.
Set clear targets for review and approval timelines for labeling documents using effective project management. Follow up with Labeling Team members to ensure timely review and approval deadlines are met.
Update related labeling documents e.g., for products within a similar class, of different dosage forms, and for generics.
Support the use and development of current and new tools, technologies and processes to support efficient global label development and worldwide submissions and approvals.
Identify and assist teams to overcome barriers in achieving quality and compliance.
Support the development of and training for junior personnel, vendors and/or contractors, serve as a mentor.
Contribute and support the development and maintenance of job aids and guidance documents
Facilitate team and cross functional meetings.
Education Qualifications:
Experience and Attributes:
Excellent written and verbal communication skills essential.
Complete fluency in English Language.
Proven strength in logical, analytical and writing ability essential.
Knowledge of global/regional regulatory guidelines and requirements important.
Project Management capability and organizational skills:
Demonstrated project management skills and attention to detail required.
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.
Works under general supervision. Performs assignments using established procedures and general instruction on the process and desired outcome
Interpersonal and communication skills:
Clear and effective written and verbal communication skills.
Ability to liaise with stakeholders using effective means of communication.
Makes decisions to resolve moderately complex problems in standard situations
Makes decisions within guidelines and policies
Able to work in ambiguous situations as part of a Work Team
Uses own judgment to modify standard methods and techniques when necessary
Technical Skills
High attention to detail.
Ability to apply labeling regulatory guidance on formatting requirements.
Ability to consolidate comments from multiple sources (e.g., emails, meeting minutes).
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.
Applies technical skills and Work Team knowledge to achieve assigned work on projects/assignments
May act as a technical resource within own Work Team
Understands the fundamental business drivers for the company.
Systems and Document compilation skills, including:
Work Location: On premise
The annual base salary for this position ranges from $78,000.00 to $130,000.00.* In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary. 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.
* The annual base salary for this position in Tampa, FL ranges from $70,200.00 to $117,000.00.
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
