The Hub Labeling Manager is responsible for preparation of LPDs, associated LLDs and PLDs for nationally registered products for their 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 labeling
requirements and participate in the sharing of intelligence in collaboration with other Hub Labeling Managers.
Additionally, this role will serve as an SME for the use and development of current and new global tools, technologies
and processes to support label development, submission and approval; with a particular focus on digital solutions.
JOB RESPONSIBILITIES
Maintains system management for labeling activities including Global Document Management System (GDMS) and Pfizer approved labeling tracking system.
Maintenance of workflow management tools and mailboxes.
Provides ad hoc support for labeling deliverables.
Performs QC of labeling text.
Monitors system data integrity and quality checks.
To maintain system management for labeling activities including GDMS and Pfizer approved labeling tracking system.
Contributes to the completion of moderately complex projects under the direction of more senior labeling managers.
Utilizes regulatory knowledge to produce non-complex 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.
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.
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
QUALIFICATIONS / SKILLS
Basic knowledge/understanding of the principles and concepts of labeling.
Basic 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 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 key regulatory and labeling principles and local regulations.
Strong knowledge/understanding of the principles and concepts of labeling.
Strong knowledge of key regulatory and labeling principles and local regulations.
Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience.
Work Location Assignment: Hybrid
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
Pursuant to Article 24(6) of the Act of June 24, 2024 on the protection of whistleblowers, Pfizer Polska Sp. z o.o. and Pfizer Trading Polska Sp. z o.o. declare that they have adopted a joint internal reporting procedure, which, in accordance with the provisions of the aforementioned Act, is also available to persons applying for employment on the basis of an employment relationship or other legal relationship constituting the basis for providing work or services or performing functions. The content of the procedure is made available upon request sent to the contact person or to the email address [email protected].
Regulatory Affairs#LI-PFE
