JOB SUMMARY
The Senior Associate is responsible for executing the content management of non-complex Local Product Documents (LPDs), Local Label Documents (LLDs) and Patient Leaflets (PLDs) for nationally registered products for their assigned products across multiple countries/regions.
Provides associated labeling support to the rest of the ILG organisation, working in collaboration with Hub Labeling Managers.
JOB RESPONSIBILITIES
- Supports Hub Labeling Manager (Manager) by maintaining system management for labeling activities including Global Document Management System (GDMS) and Pfizer approved labeling tracking system. Maintenance of workflow management tools and mailboxes.
- Provides ad hoc support for labeling deliverables.
- Performs QC of labeling text.
- Monitors system data integrity and quality checks.
- To maintain system management for labeling activities including GDMS and Pfizer approved labeling tracking system.
- Contributes to the completion of moderately complex projects under the direction of more senior labeling managers.
- Utilizes regulatory knowledge to produce non-complex LPDs, LLDs and PLDs where there are unambiguous relationships to source documents and clear local regulatory principles to follow, requesting advice or input from other functions when appropriate.
- 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.
QUALIFICATIONS / SKILLS
SKILLS
- Basic knowledge/understanding of the principles and concepts of labeling.
- Basic 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 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.
- Knowledge of key regulatory and labeling principles and local regulations.
QUALIFICATIONS
- Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience required.
EXPERIENCE
- Preferred demonstrated ability to develop strong and positive working relationships across multiple cultures and locations.
- Required demonstration of attention to detail and problem-solving skills.
- Required proven technical aptitude and ability to quickly learn new software.
- Required proven technical aptitude and ability to quickly learn regulations and standards.
- Required ‘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.
- Required ability to understand, assess and manage the regulatory implications of product strategy with regard to the product label.
- Required knowledge of global/regional regulatory guidelines and requirements in addition to knowledge of Clinical Variations is important.
- Preferred 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.
ORGANIZATIONAL RELATIONSHIPS
- Reporting relationship to Regional Labeling Head and International Labeling Team Lead.
- Partners with Pfizer PCO’s, GRA groups, GRO groups and other platform lines as required.
- Supports global, GRA, GRO and ILG initiatives as required.
RESOURCES MANAGED
May manage work / people within a matrix.
Work Location Assignment: Flexible
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
