Packaging Coordinator II

JOB RESPONSIBILITIES

• Maintains system management for labeling activities including Global Document Management System (GDMS) and client approved labeling tracking system.
• Maintenance of workflow management tools and mailboxes.
• Monitors system data integrity and quality checks.
• Utilizes regulatory knowledge to produce non-complex LPDs LLDs and PLDs.
• Produces other labeling-related documentation for submission to HAs such as track change versions annotated labels comparison tables and annotated supporting documentation.
• Performs QC check of other colleagues work.
• Identifies incremental improvements to labeling-related processes and systems for exploration by more senior labeling managers.
• Meets defined targets on productivity quality and compliance as set by and overseen by management.
• Utilizes regulatory labeling expertise to review develop and deliver labeling documents for submission to the Regulatory Authorities across markets/regions requesting medical advice and input from other functions as appropriate.
• Supports provision of other deliverables within the scope of ILG responsibilities e.g. readability testing.
• Works on projects involving the use of current and new global tools technology and processes to support label development submission and approval; with a particular focus on digital solutions.
• Takes part in research incubator work leveraging technologies in process automation machine-learning business process management etc.
• Works with R&D lead(s) with digital transformation project activities to transform regulatory data systems and processes into an integrated hyper efficient learning platform corresponding to GRSs overarching roadmap.
• Assists with labeling data analysis.
• Creates or enhances SharePoint web pages.
• The full range of labeling documentation may be produced including labels for NCEs or Product Extensions as well as complex revisions
• For deliverables in scope prepares responses to inquiries from client colleagues in response to inspection activities and regulatory agency questions and represents client during HA Inspections.

QUALIFICATIONS

• Life sciences pharmacy graduate or equivalent; or equivalent relevant professional experience.
• Fluency in English language important however multi-language skills are advantageous.
• Experience working with structured data such as in enterprise databases MS Excel MS SharePoint and/or MS Access.
• Knowledge of key regulatory and labeling principles and local regulations.
• Hands on registration experience associated with development maintenance and commercialization activities within Regulatory Affairs; preferably from the perspective of a Country office or Regional Regulatory Strategy important and advantageous especially with the perspective of the implications of a Core Data Sheet on LPDs.
• 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.
• Proven technical aptitude and ability to quickly learn regulations and standards.
• Ability to understand assess and manage the regulatory implications of product strategy with regard to the product label.
• Knowledge of global/regional regulatory guidelines and requirements in addition to knowledge of Clinical Variations is important.
• Ability to interpret and apply regional/local regulatory guidance around labeling and associated supportive documentation both in the pre-approval and post approval (maintenance) stages preferred.
• Demonstrated project management attention to detail and problem-solving skills.
• Provenstrength in logical analytical and writing ability essential.

SKILLS

• Strong knowledge/understanding of the principles and concepts of labeling.
• Strong 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 SOPs systems and processes in underpinning quality and compliance of deliverables.