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Hub Labeling Manager
hace 1 mes
Location: Colombia - Bogota - Suba
Time Type: Full-time
Posted on: 13 days ago
Job Requisition ID: 4922763
Organizational Relationship(s):
This position reports to the locally based Regional Labeling Head, International Labeling Team Lead, or to a Senior Manager in International Labeling Group.
Position Purpose:
The Hub Labeling Senior Associate level is responsible for executing the content management of non-complex local product documents (LPDs), Local Label Documents (LLDs), and Patient Leaflets for nationally registered products across multiple countries/regions. The Hub Labeling Senior Associate also provides support to the rest of the ILG organization.
Primary Responsibilities:
- Contributes to the completion of moderately complex projects under the direction of more senior labeling managers.
- Utilizes regulatory knowledge to produce noncomplex LPDs, LLDs, and Patient Leaflets, requesting advice or input from other functions when appropriate.
- Produces labeling-related documentation for submission to HAs such as track change versions, annotated labels, comparison tables, and annotated supportive documentation.
- Provides QC support to other labeling colleagues.
- Identifies incremental improvements to labeling-related processes and systems for exploration by more senior labeling managers.
- Meets defined targets on productivity, quality, and compliance, as set by management.
Technical Skill Requirements:
- Strong knowledge/understanding of the principles and concepts of labeling.
- Strong knowledge of key regulatory and labeling principles and local regulations.
- Proficient in use of systems consistent with business expectations, understanding the importance of systems in maintaining high compliance figures.
- Fluency in English and Spanish; 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.
- Registration experience associated with development, maintenance, and commercialization activities within Regulatory Affairs (Human Medicinal Products); preferably from the perspective of a Country office or Regional Regulatory Strategy.
- Ability to understand regulatory implications of product strategy regarding the product label and associated impacts.
- Ability to interpret and apply regional/local regulatory guidance around labeling and associated supportive documentation.
- Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations.
- Knowledge of global/regional regulatory guidelines and requirements, in addition to knowledge of Clinical Variations.
- Demonstrated project management, attention to detail, and problem-solving skills required.
- Proven technical aptitude and ability to quickly learn new software, regulations, and standards.
Work Location Assignment: Hybrid
EEO (Equal Employment Opportunity) & 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, or disability.
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