Use Your Power for Purpose
As DLM-Associate in 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 responsible for supporting Labeling Managers by maintaining documentation in labeling systems so that SOP requirements are fulfilled
Help maintain workflow management tools and mailboxes and provide associated 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
QUALIFICATIONS / SKILLS
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
1-5 yrs relevant 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
ORGANIZATIONAL RELATIONSHIPS
Reporting relationship to GILA Head Labeling Operations, International Labeling Lead, Partners with Pfizer Global Regulatory groups and other platform lines as required
Supports Global Regulatory and Labeling Operations initiatives as required
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs