Senior Manager, Global Labelling

Title:

Senior Manager, Global Labelling

Company:

Ipsen Innovation (SAS)

Job Description:

Summary / purpose of the position

To develop and maintain Core labelling documents and support USPI/other local product information throughout the product life cycle in accordance with Ipsen Processes for assigned product(s)

To provide labelling guidance to support product teams and senior management in defining labelling strategy

To provide oversight of global labelling activities for assigned products

To contribute to the development of the labelling function and the implementation of labelling processes

To guide teams to ensure compliance with SOPs

Main responsibilities / job expectations

• Create and maintain regulatory compliant, competitive and up to date Company Core Data Sheet (CCDS) for assigned key development projects and marketed products
• Lead efficiently cross functional labeling teams as the Global Labeling Lead or mentor staff in this role, advising team members on labelling content, requirements, and strategies for good labelling outcomes and success
• Build strong collaboration with key internal stakeholders, including Regulatory Affairs, Clinical Research, Drug Safety, Quality, Commercial, Medical Affairs, Legal, Manufacturing, Supply Chain and other functions to support development of draft label text
• Provide expertise on regional labelling requirements and labelling trends to facilitate cross functional labelling team decisions during development of the CCDS and Health Authorities negotiations.
• Influence labelling team decision based on precedent labelling negotiations experience and get alignment on proposed CCDS wording. Present proposed CCDS and key differences with EU-USPI to Executive Labelling Committee (ELC) with support of the product team to obtain internal approval before submission of major labels.
• Facilitate fast track submissions while ensuring global Labelling documents are of the highest quality and represent the safe and effective use of the product
• Review scientific data, writes effectively and summarises into the appropriate detail for labelling content. Provide input for the production of high-quality documents supporting changes to Iabelling content.
• Manage and disseminate CCDS updates to defined stakeholders within required timelines and as per agreement with partners.
• Oversee the development of local labelling content for assigned products with respect to CCDS, as applicable across regions. Interacts with Global and Local Regulatory Affairs teams to ensure timely implementation of CCDS changes into local product information that are consistent with the company's position defined in the CCDS and in compliance with local labeling regulations. Supports Global/ local  Regulatory Affairs  (GRA/LRA) to  report non-conformances (non-alignment with required CCDS changes) or deviations when applicable.
• Review worldwide labelling against the CCDS and facilitate and track implementation of changes to align with core content
• Work closely with GRA Compliance group and GRA teams to ensure oversight of CCDS updates for assigned products in Ipsen territory by ensuring a follow up of local PI submissions as per CCDS defined timelines.
• Provide overview and escalate significant labelling issues to labelling Head, ELC or Global Safety Compliance/Pharmacovigilance committees, as appropriate. Lead the creation of the annual report.
• Work with the Global Regulatory/Submission teams on planning, managing and implementing labelling updates and defines best strategy to meet business needs based on interpretation and implementation of key regional labeling regulations, guidelines, and best labeling practices. Advise labelling staff for their planning strategies as requested.
• Maintain all labelling documents in accordance with Ipsen company policies, procedures and technologies. Ensure a thorough pre-review of labelling package before ELC and Issuance Notification (IN) before CCDS dissemination for assigned products or products from labelling staff.
• Provide input based on benchmark/precedent experiences and lead activities to encourage continuous improvement within Global Labelling.
• Develop the internal process for review and resolution of health-authority feedback on draft labeling. Participate in label-related Health Authority negotiation meetings upon GRA TA request.
• Review approved PI and final artwork when key safety changes are to be implemented into production, as requested or on ad-hoc basis.
• Maintain knowledge of current rules and regulations governing global labeling activities and provide updates to labelling staff/other stakeholders.
• Manage CCDS annotations and check consistency with source documents and within CCDS sections. Instruct labelling staff and provide support as needed.
• Assist GRA/LRA in preparation of responses to labelling-related Health Authority queries and track team decisions/HA negotiations to be able to provide lessons learned to labelling staff.
• Review and approve non-conformances from CCDSs for assigned products or when requested by labelling staff.
• Ensure deviations from labeling procedures and policies are addressed appropriately and escalated to Labelling Head or head of Function as appropriate.
• Represent labelling on product-specific global regulatory subteams.
• Participate to mandatory trainings and completes training records.
• Represent Ipsen at external meetings/conferences as appropriate.

Please note: The list of activities mentioned above is not exhaustive and may evolve over time in accordance with the role and the needs of the company.

Knowledge, abilities & experience

Education / Certifications:   

• Advanced degree (or equivalent) in scientific discipline (not limited to Pharmacy, Medicine, Safety,  Biological Sciences, Medical Writing).
• Regulatory degree or related discipline preferred.
• Good knowledge of EU & US labelling regulations/guidelines. Good overview of other country/region labelling is desired.

Experience:

• Regulatory professional with 12+ years of industry experience and relevant experience  (at least 6-8 years) in global regulatory labelling and management of EU/US PI.
• Project Management experience, experience mentoring individual.

Languages:

•  Fluency in English as business language

Key Technical Competencies Required

• Direct experience leading labelling content development for complex updates/new indications through regulatory submission and review process, Health Authority negotiations resulting in product approval
• Knowledge of pharmaceutical regulation related to product information in EU and US and ability to maintain good knowledge of new external guidelines/policies pertaining to product information
• Proven experience in drafting labelling content from the review of scientific data and summarised into the appropriate detail for labelling content.
• Data analysis skills and high level of attention to detail - ability to work proactively through labelling revisions and the product review process
• Knowledge of therapeutic area(s) and be able to develop a sound knowledge of a product portfolio
• Strong collaboration, presentation, communication and interpersonal skills with ability to establish effective working relationships with a diverse range of stakeholders
• Proven project management, leading teams from multiple functional areas. History of solving regulatory labeling related problems while exhibiting ability to make wise decisions or form insightful opinions (especially in complex situations ) and a balanced, realistic understanding of issues
• Excellent verbal and written communication skills; strong technical writing and presentation skills
• Strong scientific background and/or experience, working knowledge of medical terminology and drug safety
• Highly organized with the ability to manage complex projects and timelines
• Strategic thinking, must be able to influence teams, work as a team member and independently
• Experience with E2E global labelling processes
• Experience in review process, standards, and industry best practice pertaining to labeling
• Experience working in a Documentum-based document management system (EDMS)

Hybrid model : 3 days on site & 2 days teleworking

Dans le cadre de ses recrutements IPSEN s’engage au respect de l’égalité de traitement des candidats, indépendamment du sexe, de l’âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat.