Director/Team Lead/Global Labeling Lead

JOB SUMMARY

The Global Labeling Lead Director/Team Lead

• 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.
• 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 Dir/TL 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 Dir/TL will also be knowledgeable on key labeling requirements worldwide in order to communicate the potential impact of CDS updates globally. The GLL Dir/TL will ensure that downstream impact on Country Labeling Documents (CLDs) is considered during Labeling Team discussions. The GLL Dir/TL 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.
• 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.
• Serves as the 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 Specialists so that labeling can be prepared and managed appropriately throughout Pfizer processes and systems. The GLL Dir/TL also interfaces with Hub Labeling Managers and Pfizer Country Office (PCO) colleagues to support timely and quality submissions globally.
• 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

• 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 be incorporated into CLDs worldwide
• Prioritize 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.
• Partner with Labeling Operations Managers.
• 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.
• Champion continuous improvement of business practices associated with processes and tools through liaison with relevant stakeholders. 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.
• May lead teams tasked with development of continuous improvement of business practices associated with processes and tools.
• Advocate for new labeling initiatives to labeling stakeholders across the portfolio and across the WSR/WRD organizations.
• Manages and provides ongoing guidance and mentoring to GLLs as necessary to ensure staff can satisfactorily fulfill their job roles.
• Provide back up to Labeling Cluster Head and serve as group point of contact when necessary.
• May be active in external facing activities and is effective at representing Pfizer in various industry groups (such as DIA PhRMA) or at FDA-sponsored events (e.g. Workshops AdComs).
• Enforces use of standards and best practices for execution of labeling projects.
• Demonstrates leadership skills in creating and fostering a supportive accountable and growth-driven environment.
• Demonstrates ability to exhibit sound judgement leading through ambiguity and change.

QUALIFICATIONS / SKILLS

Qualifications

Education:

• Life sciences pharmacy graduate or equivalent.
• Advanced academic qualifications/degree such as PhD an advantage but not essential.

Experience and Attributes:

• Min 8 years of pharmaceutical labeling experience required
• 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 important and advantageous.
• Proven understanding of the dynamics and purpose of company Core Data Sheets (CDS); experience in reviewing and understanding of implications of the CDS.
• Serves as a subject matter expert on external labeling guidelines and regulations and internal labeling policies and procedures.
• Proven ability to successfully understand 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.
• 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.
• 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 Team toward its goals and resolve issues. Influences senior management decisions that impact business direction.
• Consistent ability to foster strong matrix team working relationships. Proven track record of leading groups of individuals to work together on creating solutions.
• Interfaces directly with senior management as appropriate on prescribing information content and requirements and labeling policy.
• Independently seeks to identify and resolve problems in a proactive manner. Assesses impact on greater organization and identifies innovative options and/or multiple solutions.
• Proven ability to make sound decisions even in ambiguous doing so the job holder will proactively seek information and insight from a broad range of sources and weight benefits and risks before making important decisions.
• Ability to make decisions without complete information or in situations where consultation with others is not possible due to situation or time constraints.
• Interfaces directly with senior management as appropriate on labeling content and requirements and labeling policy.
• Exercises foresight and judgment in highly complex situations.

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.

Work Location Assignment:Hybrid

This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.

The annual base salary for this position ranges from $169700.00 to $282900.00. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of lifes moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution paid vacation holiday and personal days paid caregiver/parental and medical leave and health benefits to include medical prescription drug dental and vision coverage. Learn more at Pfizer Candidate Site U.S. Benefits (). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Regulatory Affairs