at Pfizer in Lake Forest, Illinois, United States
Job Description
Why Patients Need You
We’re looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.
Job Summary
+ The Global Labeling Lead (GLL) has overall accountability 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 drive 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 (CLDs) 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 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.
Job Responsibilities
+ GLLs have overall accountability to drive labeling strategy by leading the cross-functional group of subject matter experts (Labeling Teams) throughout the label development process, from creation of initial labeling documents during clinical development and through maintenance life cycle of established labels. 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.
+ GLLs advise Labeling Teams on internal labeling policies and procedures, as well as external labeling regulations and guidances, especially for the FDA and EMA, and guide the Labeling Team on the appropriate application of these labeling principles when drafting labeling updates.
+ GLLs will also ensure downstream impact of a CDS update on local country labeling is considered during Labeling Team discussions.
+ GLLs will advise Labeling Teams on competitive and precedent Labeling Intelligence while developing labeling text. 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.
+ The GLL serves as the primary point of contact for Labeling Team members (e.g. Regulatory strategy leads, Safety Risk Lead, Clinical Development, Medical, and other cross-functional SMEs)
+ GLLs partner with Labeling Operations Managers as well as Labeling Compliance so that labeling can be prepared and managed appropriately throughout Pfizer processes and systems. The GLL may also interface with Hub Labeling Managers and Pfizer Country Office (PCO) colleagues to support timely and quality submissions globally.
+ GLLrepresents the labeling strategy organization for assigned products at labeling executive committee and other Senior leader governance meetings when discussing labeling.
Qualifications
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 associated with content development and maintenance of prescribing and patient information.
+ Proven understanding of the dynamics and purpose of company Core Data Sheets (CDS); experience in reviewing and understanding of implications of the CDS.
+ Possesses advanced knowledge of external labeling guidelines and regulations and internal labeling policies and procedures.
+ 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.
+ 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 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.
+ Ability to interact effectively with all levels/roles of project team members. Demonstrated ability to communicate and/or present to senior or executive level management.
+ 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 make sound decisions even in ambiguous situations. Independently seeks to identify and resolve problems in a proactive manner.
+ Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the abil
