JOB SUMMARY

The LOM - International Associate 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.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 regulationsProficient in use of systems consistent with business expectations, and understands importance of systems in maintaining high compliance figuresFluency in English language important however multi-language skills are advantageousClear and effective written and verbal communicationsUnderstanding of the importance of Standard Operating Procedures (SOPs), systems and processes in underpinning quality and compliance of deliverablesExperience working with structured data, such as in enterprise databases, MS Excel, MS SharePoint and/or MS Access

QUALIFICATIONS

Preferred - Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience.

EXPERIENCE

Required 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.

Preferred Experience

‘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.

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Regulatory Affairs