Digital Labeling Manager (DLM) - Senior Associate

Digital Labeling Manager (DLM) - Senior Associate
Is responsible for executing the content management of non-complex local product documents (LPDs), Local Label Documents (LLDs) and Patient Leaflets 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 Mangers.

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.
 Contributes to the completion of moderately complex projects under the direction of more experienced/senior labeling managers.
 Utilize regulatory knowledge to produce noncomplex LPDs, LLDs and Patient Leaflets where there are unambiguous relationships to source documents and clear local regulatory principles to follow, requesting advice or input from other functions when appropriate.
 Production of other labeling-related documentation for submission to HAs such as track change versions, annotated labels, comparison tables and annotated supportive documentation.
 Provides QC support to other labeling colleagues.
 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

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
 Emerging ability to work innovatively and think creatively.

QUALIFICATIONS
 Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience – Required

EXPERIENCE
 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, regulations and standards - Required
 ‘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 - Required
 Ability to successfully understand regulatory implications of product strategy with regard to the product label, assessment and practical management of associated impacts - Required
 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
 Knowledge of global/regional regulatory guidelines and requirements in addition to knowledge of Clinical Variations is important - Required
 Demonstrated project management, attention to detail and problem-solving skills - Required

ORGANIZATIONAL RELATIONSHIPS

Reporting relationship to Regional Head Digital Labeling Centre, Digital Labeling Centre Team Lead, Digital Labeling Centre Supervisor or ILG Digital & Analytics Business 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: On Premise

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs