As a DLM Associate, you will support Labeling Managers in documentation maintenance, workflow management, and quality checks, ensuring compliance with labeling standards.
Use Your Power for Purpose
As a DLM-Associate in GILA Labeling Operations at Pfizer, you will play a crucial role directly contributing to the improvement of patients' lives. Your work will ensure that our products are accurately labeled, meeting regulatory requirements and providing essential information to healthcare professionals and patients. This role offers a unique opportunity to make a tangible impact on global health while working with a team of dedicated professionals.
What You Will Achieve
In this role, you will:
Responsibilities
Skills
Qualifications
Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience - Preferred.
Experience
Organisational Relationships
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.
Regulatory Affairs
As a DLM-Associate in GILA Labeling Operations at Pfizer, you will play a crucial role directly contributing to the improvement of patients' lives. Your work will ensure that our products are accurately labeled, meeting regulatory requirements and providing essential information to healthcare professionals and patients. This role offers a unique opportunity to make a tangible impact on global health while working with a team of dedicated professionals.
What You Will Achieve
In this role, you will:
- be supporting Labeling Managers by maintaining documentation in labeling systems so that SOP requirements are fulfilled
- help maintain workflow management tools and mailboxes as well as provide associated technical support
Responsibilities
- Supports Labeling Managers by maintaining documentation in GDMS, PfLEET and other systems so that SOP requirements are fulfilled
- Maintenance of workflow management tools and mailboxes
- Ad hoc support for labeling deliverables
- Proof-reading of labeling text
- System data integrity and quality checks
Skills
- Knowledge of the principles and concepts of labeling.
- Knowledge of key regulatory and labeling principles and local regulations
- Proficient in use of systems consistent with business expectations, and understands importance of systems in maintaining high compliance figures
- Fluency in English language important however multi-language skills are advantageous
- • 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
- Experience working with structured data, such as in enterprise databases, MS Excel, MS SharePoint and/or MS Access
Qualifications
Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience - Preferred.
Experience
- Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations
- Demonstration of attention to detail and problem-solving skills
- Proven technical aptitude and ability to quickly learn new software, regulations and standards
- 'Hands on' 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 important and advantageous especially with the perspective of the implications of a CDS on LPDs- Preferred
Organisational Relationships
- Reporting relationship to Head Labeling Operations, International Labeling Operations Lead, Partners with Pfizer's Global Regulatory Sciences (GRS) groups and other platform lines as required
- Supports global, GRS and Labeling Operations initiatives as required
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.
Regulatory Affairs
Top Skills
Gdms
Ms Access
Excel
Ms Sharepoint
Pfleet
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