LOM - International Manager

LOM - International Manager
JOB SUMMARY:
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.
May be 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 International Labeling organisation,
working in collaboration with Hub Labeling Mangers.
May be responsible for preparation of local product documents (LPDs) and their associated Local Language documents (LLDs) for assigned markets and updating the labeling documents on a timely basis according to internal SOPs and external regulatory requirements.
This role may act as a Subject Matter Expert (SME) on local, regional and multi-country regulatory labelling requirements and participate in the sharing of intelligence in collaboration with Hub Labeling Managers.
Additionally, this role will serve as an SME for the use and development of current and new tools, technologies and processes to support global label development, submission and approval.; with a particular focus on digital solutions.
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.
• May 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
• Interaction with other cross functional roles in the delivery and management of labeling text through the appropriate processes and systems
• Communicate, plan, prioritize and deliver labeling documents according to company targets and submission requirements; liaise with stakeholders using the most effective means of communication; presenting information in an optimal format and level of information for that audience.
• Development of subject matter expertise for assigned markets in collaboration with HLM
• Utilization of analytical skills to review request for labeling updates and appropriate implementation of defined content, recording the key decisions made.
• Working within a framework of internal SOPs and working practices, and external regulatory requirements
• Serving as an SME for the use of relevant tools and technologies within the course of the label development and translation process
• May be required to engage in necessary labelling team meetings to discuss any decisions for not making any label updates or label content as appropriate. Ensure that decisions taken for labelling are accurately captured and communicated to HLMs and appropriate stakeholders so that local and regional submission activities can be triggered in a timely fashion.
• Ensure all actions taken within role follow applicable SOPs and WIs so that high quality delivery of outputs and compliance is maintained.
• Ensure appropriate tracking of labelling projects via defined procedures and optimal use of systems.
• Champion and/or participate in implementation of digital technologies driving process improvements and efficiencies, working proactively to seek the opportunities that will benefit from digital solutions.
• For deliverables in scope, support responses to inquiries from client colleagues in response to audits, inspection activities and regulatory agency questions in collaboration with the HLM
• May mentor, train or supervise more junior colleagues in their day-to-day activities, and may review work completed by other colleagues and manage team issue resolution and escalations
• May provide vendor oversight management for day-to-day activities and manage issue resolution/escalations

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
• Knowledge of regulatory requirements and guidelines pertaining to labeling, and/or general regulatory background/experience, potentially gained in a country office environment, is preferred.
• Ability to understand, analyze and propose information into local labeling such as the LPD and Patient information and ability to logically review any impact on other sections of the same documentation.
• Ability to think creatively and work innovatively
• Familiarity with digital tools, automation technologies and application to labeling process.

QUALIFICATIONS:

• Required - Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience
• Useful - Advanced academic qualifications/degree

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
• '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
• Ability to successfully understand regulatory implications of product strategy with regard to the product label, assessment and practical management of associated impacts.
• 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.
• Knowledge of global/regional regulatory guidelines and requirements in addition to knowledge of Clinical Variations
• Demonstrated project management, attention to detail and problem-solving skills.
• Preferred - Proven strength in logical, analytical and writing ability

ORGANISATIONAL RELATIONSHIPS:

• Reporting relationship to Director Labeling Operations
• Partners with Pfizer PCO's, GRS groups, GILA and other platform lines as required.
• Supports global, GRS, GILA initiatives as required.

RESOURCES MANAGED:

• May manage people within a matrix or supervisory capacity
• May have vendor oversight responsibilities
• May have responsibilities as a people manager for 1-2 people

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.
Regulatory Affairs