Global Labeling Lead, Manager
The Global Labeling Lead (GLL) is responsible for the initial creation and relevant updates to labeling documents for their assigned products. This includes guiding the Labeling Team to develop and maintain Core Data Sheets (CDS), United States Package Inserts (USPI), Summary of Product Characteristics (SPC) for products registered in the EU via the Centralized, Mutual Recognition or Decentralized Procedures, and their associated Patient Labeling Documents.
The GLL will reinforce labeling strategy by guiding and advising the Labeling Team on internal labeling guidance and policies and will raise awareness of important factors to consider when revising the label. The GLL will keep up to date with labeling guidelines and regulations as they pertain to the development/maintenance of US and EU labeling and will advise the Labeling Team on the application of these labeling principles. The GLL will also be knowledgeable on key labeling requirements worldwide. The GLL will ensure that downstream impact on Country Labeling Documents (CLD) is considered during Labeling Team discussions. The GLL will advise the Labeling Team on the content of other labels in the same therapeutic class, including competitor 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 update a CDS/USPI/SPC through notification to stakeholders, in order to ensure that these documents are produced in a timely manner according to internal SOPs and external Position Purpose regulatory requirements. This includes setting clear targets and prioritization plans, ensuring that Labeling Teams are aware of the required timelines and following up with Labeling Team 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 Risk Lead, Functional Line SMEs, Labeling Justification Document/Clinical Overview author) and will provide day-to-day direction to Labeling Operations Managers so that labeling can be prepared and managed appropriately throughout Pfizer 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 efficient global label development and worldwide submissions and approvals.
- Utilize regulatory, labeling and project management expertise to oversee and support the development, review and delivery of CDS, USPI, SPC (for products registered in the EU via the Centralized, Mutual Recognition or Decentralized procedures) and their associated Patient Labeling Documents. Manage moderately complex labeling projects with oversight as needed.
- Engage in and contribute to Labeling Team discussions around content and format of the above mentioned documents, as well as downstream impact on CLDs worldwide.
- Act as a reviewer and approver of labeling documents ensuring that content complies with regulatory requirements and guidelines and company policies and procedures and that the label content can beincorporated into CLDs worldwide.
- Contribute to the prioritization of Labeling Team activities and set clear targets using effective project management. Follow up with Labeling Team members to secure their contributions so that internal and external deadlines are met. Identify and 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 quality delivery of outputs and compliance is maintained. Ensure appropriate tracking of labeling projects via defined procedures and optimal use of systems.
- Contribute to the development of continuous improvement of business practices associated with processes and tools. 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 activities and regulatory agency questions.
- Life sciences, pharmacy graduate or equivalent.
- Advanced academic qualifications/degree such as PhD an advantage but not essential.
Experience and Attributes:
At least 5 years of pharmaceutical labeling experience preferred.
- ‘Hands on’ pharmaceutical labeling experience associated with content development and maintenance within Regulatory Affairs (Human Medicinal Products); Perspective from HQ, Country office and/or Regional Regulatory Strategy (at a global/multi-national pharmaceutical environment) necessary. Experience at the country level is a plus.
- Proven understanding of the dynamics and purpose of company Core Data Sheets (CDS); experience in reviewing and understanding of implications of the CDS.
- Possesses solid knowledge of external labeling guidelines and regulations and internal labeling policies and procedures.
- Understands regulatory implications of product strategy with regards to the product label, assessment and practical management of associated impacts.
- Demonstrated ability to interpret and apply global and local regulatory guidance around labeling and associated 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 within global 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.
- Demonstrated project management skills and attention to detail required.
- Proven ability to negotiate, influence and problem solve.
- Regularly leads Labeling Team members to facilitate agreements and move the Labeling Team toward its goals.
- Knowledge of U.S. and EU regulations and guidelines pertaining to labeling and demonstrated ability to decipher 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 Team purpose and objectives.
- Demonstrated ability to understand how updating one section of a label may impact another and to propose recommendations to the Labeling Team.
- Clear and effective written and verbal communication skills. Ability to liaise with stakeholders using effective means of communication. Demonstrated ability to influence and negotiate where necessary, across a highly matrixed team.
- Ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy.
- Proven ability to make sound decisions. In doing so, the job holder will seek information and insight from various sources and will weigh benefits and risks before making important decisions.
- Ability to interact effectively with all levels/roles of project team members.
- Consistent ability to foster strong team working relationships.
- Ability to manage own time for all projects, and to work on many tasks in parallel.
- Identifies issues and resolves problems, escalating as necessary.
- Takes ownership and accountability for assigned projects.
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