Digital Labeling Sr. Manager
Cairo, Egypt
Job Description
JOB SUMMARY
May be responsible for executing the content management of Local Product Documents (LPDs), Local Label Documents (LLDs) and Patient Leaflets for nationally registered products for their assigned products across multiple countries/regions.
Acts as a labelling expert for local labeling and acts as a resource to the DLC Management and more junior DLMs throughout the organisation, leading or assisting in the most complex labeling projects or initiatives, and contributing to the use and development of current and new tools, technologies and processes to support global label development, submission and approval.
Sharing of intelligence and contribution to knowledge resources is also a key part of the role.
The senior manager is proactive in gathering, assessing and disseminating regulatory intelligence for use by the labeling managers as well as for use in strategic decision-making at the global group level.
The Senior Manager will insightfully seek technology solutions leveraging process automation and AI.
May lead/manage projects.
May supervise/lead colleagues/teams.
May act as delegate/deputy for the TLs.
JOB RESPONSIBILITIES
- Utilise regulatory or process expertise to review, develop and deliver core labeling documents such as the LPD and Patient Leaflet to support submissions to the Regulatory Authorities across regions, requesting medical advice or input from others when appropriate.
- May mentor, train or supervise more junior labeling managers in their day-to-day activities, and may review work completed by other colleagues
- May coordinate and triage complex labeling activities when there is a regional, global or therapeutic area impact across multiple countries
- Interprets internal/external business challenges and best practices to recommend improvements to products, processes, or services.
- Takes appropriate risks to advance innovative processes and methodologies based on comprehensive business knowledge.
- Will represent the function or region on project improvement initiatives.
- Contributes to definition of goals and group targets, and proactively feeds back issues and roadblocks to senior management.
- According to business need, utilizes project management and critical thinking expertise to review, develop and deliver fit for purpose processes for quality label deliverables.
- May lead SME forums on labeling processes and new technology implementation for labeling.
- Interprets internal business challenges and best practices to recommend improvements to products, processes, or services.
- Provides information to team regarding Pfizer labeling regulations, interpretation of supporting documents, work instructions, and understanding of market and regional nuances.
SKILLS
- Has comprehensive knowledge of the principles, concepts and theories of the discipline, and good understanding/ knowledge of principles and concepts of other labeling-related disciplines.
- Understands and applies labeling regulation in the region and in assigned local countries, and is able to interpret impact of that regulation on development of labeling text. Is aware of forthcoming changes in regulation and legislation and the impact on labeling deliverables.
- Familiarity with digital tools, particularly automation technologies, and their application to regulatory operations processes
- Ability to think creatively and innovatively with a research mindset.
QUALIFICATIONS
- Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience required.
- Advanced academic qualifications/degree such as PhD preferred.
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.
- 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 andrequirements in addition to knowledge of Clinical Variations is important.
- Demonstrated project management, attention to detail and problem-solving skills.
- Proven strength in logical, analytical and writing ability essential
- 7+ Years in equivalent role or similar.
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
Work Location Assignment: Flexible
- May manage people within a matrix. May have responsibilities as a people manager for 1-2 people
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.
Regulatory Affairs
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Job Detail
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Job IdJD1422699
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationCairo, Egypt
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EducationNot mentioned