Digital Labeling Manager (DLM) - Manager
Is 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.
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.
Senior Associate (cumulative from above)
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 Manager (cumulative from above)
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
Utilization of regulatory expertise to review, develop and deliver core/local labelling documents such as the LPD and Patient Leaflet to support submissions to the Regulatory Authorities across regions, requesting medical advice from others when appropriate.
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
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.
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.
Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience.– Required
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 - 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
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.
May manage people within a matrix. May have responsibilities as a people manager for
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
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.