Senior Manager, Hub Labeling Job at Pfizer (Sydney)

Job Description

Is responsible for executing the content management of LPDs, LLDs and PLDs for nationally registered products for their assigned products across multiple countries/regions. Acts as a subject matter expert for local labeling 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 Artificial Intelligence (AI). May lead/manage projects. May supervise/lead colleagues/teams. May act as delegate/deputy for the TLs.

Job Responsibility

Is responsible for executing the content management of LPDs, LLDs and PLDs for nationally registered products for their assigned products across multiple countries/regions
Acts as a subject matter expert for local labeling 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 Artificial Intelligence (AI)
May lead/manage projects
May supervise/lead colleagues/teams
May act as delegate/deputy for the TLs
To utilize regulatory labeling expertise to review, develop and deliver labeling documents for submission to the Regulatory Authorities across markets/regions, requesting medical advice and input from other functions as appropriate
To support provision of other deliverables within the scope of ILG responsibilities e.g. readability testing
To work on projects involving the use of current and new global tools, technology and processes to support label development, submission and approval
with a particular focus on digital solutions
To take part in research incubator work leveraging technologies in process automation, machine-learning, business process management etc
To work with R&D lead(s) with digital transformation project activities, to transform regulatory data, systems and processes into an integrated, hyper efficient learning platform, corresponding to GRS’s overarching roadmap
To assist with labeling data analysis
To create or enhance SharePoint web pages
The full range of labeling documentation may be produced, including labels for NCEs or Product Extensions, as well as complex revisions
For deliverables in scope, prepares responses to inquiries from Pfizer colleagues in response to inspection activities and regulatory agency questions, and represents Pfizer during HA Inspections
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 complex labeling activities when there is a regional, global or therapeutic area impact across multiple countries
May lead regional SME forums on labeling processes and clearly articulate expectations of the labeling process to a broad range of stakeholders
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
May represent the function or region on project improvement initiatives
Leads operational team(s) within and across Work Teams and Departments, taking responsibility for the team's milestones/deliverables
Meets strategic targets for labeling deliverables as defined for the function, and communicates progress against these targets or issues which affect these targets, and proposes remediation
Contributes to definition of goals and group targets, and proactively feeds back issues and roadblocks to senior management

Requirements

Life sciences, pharmacy graduate or equivalent
or equivalent relevant professional experience
Advanced academic qualifications/degree such as PhD
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
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
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
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
Demonstrated project management, attention to detail and problem-solving skills
Proven strength in logical, analytical and writing ability essential
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
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

Nice to have

Multi-language skills are advantageous
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

What we offer

Paid parental leave
Access to Health & Wellness apps
Career Growth Experiences program
Recognition & rewards program
Paid volunteer days
Life Insurance Benefits
Pfizer Learning Academy access to top content providers
Access to flu vaccines & skin checks
Options to purchase additional leave
Salary packaging & novated lease options

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Senior Manager, Hub Labeling

Job Description

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