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Compliance & Oversight Lead, Manager

Employer
Pfizer
Location
Denver, Colorado, United States;Collegeville, Pennsylvania, United States;New York City, New York, United States;
Salary
Competitive
Closing date
May 25, 2022

View more

Discipline
Other, Legal/Regulatory Affairs
Position Type
Full Time
Job Type
Manager
Organization Type
Pharma
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Why Patients Need You

We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering and adapting to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.

What You Will Achieve

This role provides critical operational support to the Global Labeling Management (GLM) organization, a key enabler of Pfizer labeling strategy to drive the initial creation and maintenance of global prescribing information documents include Investigator's Brochures, core data sheets, USPIs and Pan-EU SmPCs.

You will facilitate the GLM business process, data quality and compliance by performing routine process and quality monitoring. Actively following up with team members to facilitate resolution of process or data discrepancy issues to ensure operational excellence.

Your operational business management and customer service skills will be relied upon to effectively manage our global product label information maintain our Pfizer Reference Label designations, interface with Business Partners, and Labeling Universe.

You will be part of a team of compliance and oversight leads driven to continuously improve process compliance and performance by contributing to the implementation of business process changes and applicable remediation work.

How You Will Achieve It
  • Triage global product label management mailboxes to trigger appropriate business processes, disseminate information, and ensure resolution of queries
  • Maintain tracking logs for global product label information
  • Generate process monitoring reports, produce summary reports and actively follow up with internal stakeholders to resolve identified issues.
  • Support departmental non-drug product initiatives by providing project coordination support and contributing to the development and/or revision of labeling procedural documents.


Qualifications

Must-Have
  • Bachelor's Degree or equivalent
  • 3-8 years of experience in global/multi-national pharmaceutical environment
  • Ability to work independently and manage multiple priorities at one time
  • Demonstrated excellence in project coordination and/or operational business management activities
  • Demonstrated track record of delivery to time and quality
  • Aptitude for customer service, facilitation, problem solving and conflict resolution
  • Demonstrated effective oral and written communication skills
  • Proven technical aptitude and ability to swiftly learn new processes and systems.

Nice-to-Have
  • Experience in labeling and/or regulatory affairs role
  • Experience in Continuous Improvement methodologies
  • Ability to synthesize data and effectively summarize conclusions to project leaders/key stakeholders
  • Experience working cross-functionally on broad and strategic initiatives
  • Knowledge and experience with labeling or similar tracking and document management systems.


Other Job Details

Last Day to Apply: May 30, 2022

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

Regulatory Affairs

#LI-Remote #LI-PFE
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