Senior Labeling Specialist
hace 5 días
Job Summary
This role is responsible for executing the content management of non-complex local product documents, Local Label Documents, and Patient Leaflets for nationally registered products across multiple countries/regions. The successful candidate will contribute to the completion of moderately complex projects under the direction of more senior labeling managers.
Key Responsibilities
- Utilize regulatory knowledge to produce non-complex LPDs, LLDs, and Patient Leaflets where there are unambiguous relationships to source documents and clear local regulatory principles to follow.
- Provide QC support to other labeling colleagues.
- Identify incremental improvements to labeling-related processes and systems for exploration by more senior labeling managers.
- Meet defined targets on productivity, quality, and compliance, as set by and overseen by management.
Requirements
- Strong knowledge/understanding of the principles and concepts of labeling.
- Fluency in English and Spanish languages.
- Clear and effective written and verbal communications.
- Understanding of the importance of Standard Operating Procedures (SOPs), systems, and processes in underpinning quality and compliance of deliverables.
Qualifications
- Life sciences, pharmacy graduate or equivalent (desirable); or equivalent relevant professional experience.
- Ability to successfully understand regulatory implications of product strategy with regard to the product label, assessment, and practical management of associated impacts.
About Pfizer
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, or disability.
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