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Senior Labeling Lead

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Amsterdam, Noord-Holland, Nederland NLF Fortrea Netherlands BV Voltijd

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

The Senior Global Labeling Lead (SGLL) 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. This may also include Regulatory Authority driven documents such as the Core Safety Profile.

The SGLL will guide and advise the Labeling Team on internal labeling guidances and policies and will raise awareness of important factors to consider when revising the label. The SGLL 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 SGLL will also be knowledgeable on key labeling requirements worldwide, in order to ensure that CDS updates may be implemented globally. The SGLL will review the downstream impact of CDS updates on Local Product Documents (LPD) and ensure that downstream impact on LPDs is considered during Labeling Team discussions. The SGLL 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 SGLL provides project management to the Labeling Team throughout the entire process, from the decision 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 SGLL 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 Specialists so that labeling and decision documents can be prepared and managed appropriately throughout Client processes and systems. The SGLL also interfaces with Hub Labeling Managers and PCO colleagues to support timely and quality submissions globally. The SGLL 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.

Primary Responsibilities

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. 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 Specialists. 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 Specialists and Regulatory Strategists. For deliverables in scope, support responses to inquiries from Client colleagues related to inspection activities and regulatory agency questions.

Requirements

5-6 year of experience and 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 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.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.