LOM
LOM-InternationalAssociate(Labeling)
Neural analysis suggests this role is
optimal for Mid+ candidates.
“LOM - International Associate (Labeling) at LOM. Skills: maintaining documentation in labeling systems, maintenance of workflow management tools and mailboxes, technical support, labeling. 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.”
What You'll Achieve.
SOP requirements are fulfilled; maintaining high compliance figures
Industry & Context.
problem-solving skills
What They're Looking For.
Must Have
Demonstrated ability to develop 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., 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, 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
Nice to Have
Life sciences, pharmacy graduate or or equivalent relevant professional 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.
What You'll Do.
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.
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.
How You'll Work.
Team & Collaboration
Demonstrated ability to develop and positive working relationships across multiple cultures and locations.
Communication Scope
Clear and effective written and verbal communications; multi-language skills are advantageous
Full Job Description
**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 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**_ * 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
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