Global Labeling Lead (Director) Oncology/Vaccines and Other areas
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 (LT) 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 LT 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 LTs are aware of the required timelines and following up with LT 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 LT (e.g. Regulatory Strategist, Safety Lead, Functional Line SMEs, Labeling Justification /Clinical Overview author) and will provide day-to-day direction to Labeling Operations Mgrs. so that labeling can be prepared and managed appropriately throughout Pfizer processes and systems.
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 & approvals.
- Utilize regulatory, labeling & 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) & their associated Patient Labeling Documents. Manage complex labeling projects (e.g., development labeling for NCEs and NMEs) with conflicting priorities & minimal oversight.
- Engage in and contribute to LT 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 be incorporated into CLDs worldwide.
- Prioritize LT activities and set clear targets using effective project management. Follow up with SMEs to secure their contributions so that internal & 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.
- Contribute to the development of continuous improvement of business practices associated with processes & 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 & regulatory agency questions.
- May lead teams tasked with development of continuous improvement of business practices associated with processes & tools.
- Advocate for new labeling initiatives to labeling stakeholders across the portfolio and Pfizer.
- Train & provide guidance and mentorship to other Global Labeling Leads as needed.
- Provide back up to Labeling Cluster Head and serve as group point of contact when necessary.
- Bachelor degree plus 14 years experience
Experience and Attributes:
- At least 10 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 important and advantageous.
- Proven understanding of the 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, regulations & internal labeling policies and procedures.
- Proven ability to successfully understand regulatory implications of product strategy with regards to the product label, assessment & 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 & post approval (maintenance) stages.
- Demonstrated ability to develop strong and positive working relationships across multiple cultures & within global environment.
- Knowledge of global/regional regulatory guidelines & requirements important.
- Excellent written & verbal communication skills essential.
- Complete fluency in English Language.
- Strong project management skills and attention to detail required.
- Proven ability to negotiate, influence & problem solve.
- Knowledge of U.S. and EU regulations & guidelines pertaining to labeling and demonstrated ability to decipher & 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 & to propose recommendations to the Labeling Team.
- Clear & 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 & 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 team members to facilitate agreement, 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 ability to make sound decisions. In doing so, the job holder will proactively seek information & insight from a broad range of sources & weigh benefits and risks before making important decisions.
- Interfaces directly with senior management as appropriate on prescribing information content &d 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.
- Ability to also make decisions without complete information or in situations.
- Interfaces directly with senior management as appropriate on labeling content & requirements & labeling policy.
- Exercises foresight & judgment in highly complex situation
- Master degree plus 12 years experience
- Life sciences, pharmacy graduate or equivalent.
- Advanced academic qualifications/degree such as PhD an advantage but not essential.
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.
Other Job Details:
Last Date to Apply for Job: 04/15/22
Additional Location Information:
NO Relocation Package
Eligible for Employee Referral Bonus
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