JOB TITLE:
Hub Labeling Senior Associate
REPORTS TO:
Team Lead, Hub Labeling Manager
DIVISION/BUSINESS LINE:
Pfizer Research & Development (PRD)
VERSION DATE:
16-Aug-2023
SUB DIVISION:
Global & International Labeling & Artwork (GILA)/ International Labeling Group (IL)
DEPARTMENT NAME:
Global Regulatory Sciences (GRS)
LOCATION:
Egypt
LEVEL:
Associate
(Grade: GJL060)
JOB SUMMARY
The HLM 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 organization, working in collaboration with Hub Labeling Managers.
JOB RESPONSIBILITIES
- Contributes to the completion of moderately complex projects under the direction of more senior labeling managers.
- Utilizes regulatory knowledge to produce 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, as required.
- 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
- Good knowledge/understanding 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 (written and spoken) in English language required, however multi-language skills are advantageous such as the ability to QC check scientific/medical content in Arabic in line with reference label text.
- 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.
QUALIFICATIONS
- Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience
EXPERIENCE
- Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations is preferred.
- 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.
- Hands on’ registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs; from the perspective of a Country office or Regional Regulatory Strategy is important and advantageous especially with the perspective of the implications of a Core Data Sheet on LPDs.
- 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 is preferred.
- Demonstrated project management, attention to detail and problem-solving skills is preferred.
ORGANIZATIONAL RELATIONSHIPS
- Reporting relationship to International Labeling Team Lead.
- Partners with CRSs, GRS groups, GRO groups and other platform lines as required.
- Supports global, GRS and ILG initiatives as required.
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.