Senior Manager, GLL

Job Description

Job Summary: The Global Labeling Lead (GLL) has overall accountability for the initial creation and relevant updates to labelingdocuments for their assigned products. This includes guiding the Labeling Team to develop and maintain Core DataSheets (CDS), United States Package Inserts (USPI), Summary of Product Characteristics (SPC) for products registered inthe EU via the Centralized, Mutual Recognition or Decentralized Procedures, and their associated Patient LabelingDocuments.The GLL will drive labeling strategy by guiding and advising the Labeling Team on internal labeling guidance and policiesand will raise awareness of important factors to consider when revising the label. The GLL will keep up to date withlabeling guidelines and regulations as they pertain to the development/maintenance of US and EU labeling and willadvise the Labeling Team on the application of these labeling principles. The GLL will also be knowledgeable on keylabeling requirements worldwide. The GLL will ensure that downstream impact on Country Labeling Documents (CLDs) isconsidered during Labeling Team discussions.The GLL will advise the Labeling Team on the content of other labels in the same therapeutic class, includingcompetitor labeling, to help guide the team in developing labeling text.The GLL provides project management to the Labeling Team throughout the entire process, from the request to updatea CDS/USPI/SPC through notification to stakeholders, in order to ensure that these documents are produced in a timelymanner according to internal SOPs and external regulatory requirements. This includes setting clear targets andprioritization plans, ensuring that Labeling Teams are aware of the required timelines and following up with LabelingTeam members throughout the process so that deliverables remain on target to meet internal and external deadlines.The GLL serves as the GLM primary point of contact for Labeling Team members (e.g. Regulatory Strategist, Safety RiskLead, Functional Line SMEs, Labeling Justification Document/Clinical Overview author) and will provide day-to-daydirection to Labeling Operations Managers so that labeling can be prepared and managed appropriately throughoutPfizer processes and systems. The GLL also interfaces with Hub Labeling Managers and Pfizer Country Office (PCO)colleagues to support timely and quality submissions globally.The GLL will support the use and development of current and new tools, technologies and processes to support efficientglobal label development and worldwide submissions and approvals.Job Responsibilities: Utilize regulatory, labeling and project management expertise to oversee and support the development, reviewand delivery of CDS, USPI, SPC (for products registered in the EU via the Centralized, Mutual Recognition orDecentralized procedures) and their associated Patient Labeling Documents. Manage complex labeling projects(e.g., development labeling for NCEs and NMEs) with some oversight.Engage in and contribute to Labeling Team discussions around content and format of the above mentioneddocuments, as well as downstream impact on CLDs worldwide.Act as a reviewer and approver of labeling documents ensuring that content complies with regulatoryrequirements and guidelines and company policies and procedures and that the label content can beincorporated into CLDs worldwide.Prioritize Labeling Team activities and set clear targets using effective project management. Follow up withLabeling Team members to secure their contributions so that internal and external deadlines are met. Identifyand assist teams to overcome barriers in achieving quality and compliance.Ensure all actions taken within role follow applicable SOPs and associated documents so that high qualitydelivery of outputs and compliance is maintained. Ensure appropriate tracking of labeling projects via definedprocedures and optimal use of systems.Contribute to the development of continuous improvement of business practices associated with processes andtools. Advocate for new labeling initiatives to immediate labeling stakeholders (e.g., Labeling Teams).For deliverables in scope, support responses to inquiries from Pfizer colleagues related to inspection activitiesand regulatory agency questions. Member of teams tasked with development of continuous improvement ofbusiness practices associated with processes and tools.Advocate for new labeling initiatives to labeling stakeholders within Therapeutic Area or Business Unit.Will train and provide guidance to other Global Labeling Leads as needed.Preferred Education: Life sciences, pharmacy graduate or equivalent. Advanced academic qualifications/degree such as PhD an advantage but not essential.Experience and Attributes: At least 8 years of pharmaceutical labeling experience Hands on pharmaceutical labeling experience associated with content development and maintenance withinRegulatory Affairs (Human Medicinal Products); Perspective from HQ, Country office and/or RegionalRegulatory Strategy (at a global/multi-national pharmaceutical environment) necessary. Experience at thecountry level important and advantageous. Proven understanding of the dynamics and purpose of company Core Data Sheets (CDS); experience inreviewing and understanding of implications of the CDS. Possesses advanced knowledge of external labeling guidelines and regulations and internal labeling policies andprocedures. Proven ability to successfully understand regulatory implications of product strategy with regards to theproduct label, assessment and practical management of associated impacts. Demonstrated ability to interpret and apply global and local regulatory guidance around labeling andassociated supportive documentation, both in the pre-approval and post approval (maintenance) stages. Demonstrated ability to develop strong and positive working relationships across multiple cultures and withinglobal environment. Knowledge of global/regional regulatory guidelines and requirements important. Excellent written and verbal communication skills essential. Complete fluency in English Language. Proven strength in logical, analytical and writing ability essential. Strong project management skills and attention to detail required. Proven ability to negotiate, influence and problem solve.Technical Skills: Knowledge of U.S. and EU regulations and guidelines pertaining to labeling and demonstrated ability todecipher and understand implications of label changes on pending and approved labels. Demonstrated knowledge and understanding of company Core Data Sheets and the dynamics of Labeling Teampurpose and objectives. Demonstrated ability to understand how updating one section of a label may impact another and to proposerecommendations to the Labeling Team. Clear and effective written and verbal communication skills. Ability to liaise with stakeholders using effectivemeans of communication. Demonstrated ability to influence and negotiate where necessary, across a highlymatrixed team. Ability to work well in cross-functional teams, exhibiting a combination of active listening skills and theconfidence to guide decision-making for the document content strategy. Ability to interact effectively with all levels/roles of project team members. Ability to manage own time for all projects, and to work on many tasks in parallel. Takes ownership and accountability for assigned projects. Proven ability to effectively lead Labeling team members to facilitate agreements, drive the Labeling Teamtoward its goals, and resolve issues. Consistent ability to foster strong matrix team working relationships. Proven track record of facilitating groupsof individuals across groups to work together on creating solutions. Proven ability to make sound decisions even in ambiguous situations. In doing so, the job holder will proactivelyseek information and insight from a broad range of sources and weigh benefits and risks before makingimportant decisions. Interfaces directly with senior management as appropriate on labeling content and requirements. Interfacesdirectly with senior management as appropriate on prescribing information content and requirements. Independently seeks to identify and resolve problems in a proactive manner.Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Regulatory Affairs #LI-PFE,

Keyskills :
financesalesltdmisaccountancyequal employment opportunitycore datadata sheetsfollowing uplife sciencespackage insertsproduct strategytherapeutic area