Senior Labeling Lead

Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Summary of Responsibilities:

• Utilize regulatory, labeling and project management expertise to oversee and support the development, review and delivery of CDS, CSI, USPI, SPC (for products registered in the EU via the Centralized, Mutual Recognition or Decentralized procedures) and their associated Patient Labeling Documents.
• Engage in and contribute to Labeling Team discussions around content and format of the above-mentioned documents, as well as downstream impact on LPDs worldwide.
• Act as a reviewer and signatory during review of labeling ensuring that content complies with regulatory requirements and guidelines and company policies and procedures and that the label content can be transcribed into the LPDs worldwide.
• Prioritize Labeling Team activities and set clear targets using project management tools. 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.
• Oversee and direct Labeling Operations Managers.
• Communicate label update plans to the Hub Labeling Managers in a timely manner.
• 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.
• Facilitate cross-functional and team awareness and understanding of regulatory issues as appropriate.
• Champion continuous improvement of business practices associated with processes and tools through liaison with Hub Labeling Managers, Labeling Operations Managers and Regulatory Strategists.
• For deliverables in scope, support responses to inquiries from Pfizer colleagues related to inspection activities and regulatory agency questions.
• Lead client internal labeling initiatives involve in strategic decisions.
• The LL will guide and advise 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, to ensure that CDS/CSI updates may be implemented globally. The GLL will review the downstream impact of CDS/CSI updates on Local Product Documents (LPD) and ensure that downstream impact on LPDs 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 LL provides project management to the Labeling Team throughout the entire process, from the decision to update a CDS/CSI/USPI/SPC through notification to stakeholders 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 LL serves as the GLM primary point of contact for Labeling Teams (e.g. WRS Strategist, Functional Line SMEs, Labeling Justification Document/Clinical Overview author) and will provide day-to-day direction to Labeling Operations Managers so that labeling and decision documents can be prepared and managed appropriately throughout Pfizer processes and systems. The GLL also interfaces with Hub Labeling Managers and PCO colleagues to support timely and quality submissions globally.
• The LL 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.
• Manage Development product end to end labeling updates.
• And all other duties as needed or assigned.

Qualifications (Minimum Required):

• Life sciences, pharmacy graduate or equivalent.
• Advanced academic qualifications/degree such as PhD an advantage but not essential.
• Minimum 7 to 8 yrs. of relevant experience in Strategic/Global labeling.
• English language, both written and oral.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

• Experience and Attributes:
• Significant ‘hands on’ registration experience associated with development, maintenance and commercialization activities 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), Core Safety Information (CSI); experiences of review and implications of the CDS/CSI an advantage.
• 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 locations.
• Understanding of regulatory authority philosophy and expectations.
• 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.
• Technical Skills:
• Knowledge of global/regional regulations and guidelines pertaining to labeling and demonstrated ability to decipher and understand implications of label changes on pending and approved labels across the regions.
• Demonstrated knowledge and understanding of company Core Data Sheets, Core Safety Information documents 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.
• Fluency in English language important; multi-language skills are advantageous.
• 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.
• Handled Development product labeling update.

Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

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