Digital Labeling Manager

2 months ago

Hanoi, Vietnam Pfizer Full time

JOB SUMMARY

Is responsible for supporting Labeling Managers by maintaining documentation in labeling systems so that SOP requirements are fulfilled. Maintenance of workflow management tools and mailboxes and associated technical support are also an essential part of the role.

JOB 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.

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
- 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

Provide the primary groups or key role(s) that this role will have interaction with as a regular part of the Job responsibilities.

Include any external interactions as appropriate.
- Reporting relationship to Regional Head Digital Labeling Centre, Digital Labeling Centre Team Lead, Partners with Pfizer PCO’s, GRA groups, GRO groups and other platform lines as required.
- Partners with Pfizer PCO’s, GRA groups, GRO groups and other platform lines as required
- Supports global, GRA, GRO and ILG initiatives as required.

Work Location Assignment: On Premise

LI_PFE

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs

LI-PFE

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