Senior Manager, Data Transparency & Regulatory Disclosure

Ipsen; Greater London; Ibrido; GBP 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

Ipsen Biopharm Ltd recherche un Senior Manager, Data Transparency et Regulatory Disclosure, basé à Londres ou Paris, dans l’équipe Global Regulatory Affairs Excellence. Vous dirigerez les activités de disclosure clinique, gèrerez les demandes FOI et collaborerez avec des partenaires externes et des équipes internes pour assurer conformité et transparence.

Le poste exige une expertise en clôture des données cliniques, une forte capacité d’influence et la gestion de fournisseurs, avec une approche

Competenze

• Gestion des activités de disclosure et de publication clinique.
• Gestion des demandes FOI et conformité réglementaire.
• Collaboration transfonctionnelle et supervision de fournisseurs.

Mansioni

• Planifier et exécuter les activités de disclosure clinique sur les registres publics et plateformes réglementaires.
• Gérer le contact TA DTRD pour les domaines thérapeutiques assignés et conseiller sur les exigences de disclosure.
• Maintenir le suivi des activités de disclosure et assurer la traçabilité dans les systèmes (eTMF, iDOC).
• Contribuer à l’amélioration continue des processus et à la gestion de la relation avec les fournisseurs.

Conoscenze

Disclosure management

Vendor management

Regulatory compliance

Cross-functional collaboration

Project leadership

Formazione

Bachelor's or master's degree in life sciences

Strumenti

eTMF

iDOC

Disclosures software

Descrizione del lavoro

## Senior Manager, Data Transparency & Regulatory DisclosurePostuler: London (UK): Paris: Temps complet: Offre publiée aujourd'hui: R-22828**Titre :**Senior Manager, Data Transparency & Regulatory Disclosure**Société:**Ipsen Biopharm Ltd**A propos d'Ipsen:**Ipsen est un groupe biopharmaceutique mondial de taille moyenne, spécialisé dans les médicaments transformateurs dans trois aires thérapeutiques : l'oncologie, les maladies rares et les neurosciences. Forts de près de 100 ans d'expérience en développement, avec des Hubs mondiaux aux États-Unis, en France et au Royaume-Uni, nous focalisons nos efforts là où les besoins médicaux non satisfaits sont importants, grâce à la recherche et à l'innovation.Nos équipes passionnées, présentes dans plus de 40 pays, se concentrent sur l'essentiel et s'efforcent chaque jour d'apporter des médicaments aux patients dans 88 pays. Nous construisons un environnement de travail qui met en avant un leadership centré sur l'humain et favorise une culture de collaboration, d'excellence et d'impact. Au sein d’Ipsen, chaque individu est encouragé à être soi-même, à grandir et à s’épanouir aux côtés du succès de l'entreprise. Rejoignez-nous dans notre démarche vers une croissance durable, en créant un impact réel sur les patients et la société.Pour plus d'informations, visitez notre site web à l'adresse **https://www.ipsen.com** et suivez nos dernières actualités sur **LinkedIn** et **Instagram**.**Description de l'emploi :**Senior Manager, Data Transparency and Regulatory DisclosureGlobal Regulatory Affairs Excellence, R&DDirector, Head of Regulatory Clinical Trial Excellence & Data TransparencyParis, France & London, United KingdomWHAT - Summary & Purpose of the PositionReporting to the Head of the Regulatory Clinical Trial Excellence & Data Transparency within GRA Excellence, the Senior Manager, Data Transparency and Regulatory Disclosure (DTRD) plays a strategic and operational leadership role in advancing Ipsen’s global clinical data transparency and disclosure agenda. This position serves as a subject matter expert, supporting cross-functional teams and strategic partners to ensure compliance with global and local transparency regulations, while fostering a culture of excellence, innovation, and collaboration.Key Responsibilities:• Lead or support the planning and execution of clinical data disclosure activities across public registries and regulatory platforms (e.g., CTIS, EMA Policy 0070, Health Canada PRCI).• Act as the primary DTRD contact for assigned therapeutic areas (e.g., neuroscience, rare diseases, oncology), managing end-to-end disclosure processes and advising on regulatory requirements.• Govern and support access to information requests under Freedom of Information (FOI) laws (e.g., US FOIA, EMA Policy 0043), ensuring timely and compliant responses.• Manage relationships with external vendors supporting transparency, lay language summaries, and redaction services, ensuring quality, timelines, and budget adherence.• Communicate complex strategic concepts clearly and effectively, tailoring messages to diverse internal and external audiences.• Lead cross-functional collaboration to ensure transparency deliverables remain on track and within scope.• Drive process improvements and implement new technologies to enhance operational efficiency and compliance.• Contribute to regulatory intelligence, external engagement, SOPs and training material development to align with evolving global standards.• Demonstrate thought leadership by presenting industry trends, benchmarking insights, and best practices to internal stakeholders and at external events.• Proactively identify areas for improvement and develop strategic solutions to mitigate risks and maintain business continuity.WHAT - Main Responsibilities & Technical Competencies1. Management of Therapeutic Area (TA) Disclosure Activities- Accountable for assessing the applicability of clinical studies and marketing applications for disclosure under US, EU, and other applicable regulations and Ipsen policy, and for planning and managing disclosure activities accordingly.- Act as the DTRD TA lead for assigned therapeutic areas (e.g., neuroscience, rare diseases, oncology), offering expert guidance on disclosure requirements and best practices, while balancing compliance and transparency obligations with a global strategic perspective and the need to safeguard Ipsen’s interests.- Review study protocols and product-related documents to identify confidential information and determine suitability for public disclosure.- Act as study team member and participate in study and asset team meetings to raise awareness of disclosure requirements throughout the product lifecycle.- Plan and coordinate the preparation of:o Study information for public registries (e.g., ClinicalTrials.gov, EU Clinical Trial Register, CTIS, EU RWD Catalogue).o Lay protocol synopses and lay summaries.o Anonymized/redacted documents for public registries, journal publications, or ad hoc requests.o Anonymized/redacted package for clinical data publication under Policy0070 and PRCI.o Access requests or response to access requests under FOI laws.- Prepare response to agency queries related to CTAs, clinical data publication, and access requests.- Maintain accurate tracking of disclosure activities and ensure documentation is up to date in systems such as eTMF, iDOC and relevant disclosure software.2. Vendor Management & Partnership Oversight- Oversee work delegated to preferred vendors supporting submissions to clinical public registries, preparation of lay summaries, and anonymization/redaction services.- Act as the key point of contact for vendor coordination and dispatch project-related work in alignment with the Function Head guidance.- Collaborate with vendors and internal stakeholders to optimize efficiency, ensure quality deliverables, and maintain strong partnerships.- Monitor vendor performance to ensure adherence to quality and compliance standards, escalating issues to the Function Head as needed.- Support the Function Head in planning and managing budgets for outsourced activities, including contract renewals and participation in procurement-led tender processes.3. Global Operational Excellence & Transversal Activities- Manage shared mailboxes for internal and public inquiries, ensuring timely and compliant responses.- Develop and execute integration plans for new assets entering the pipeline.- Support Function Head in cross-functional activities and/or projects, including:o Governance of Ipsen’s data transparency activities across departments (i.e., including voluntary data sharing and publications).o Oversight of Ipsen.com content related to clinical trials and transparency.o Participation in steering committees and project kick-offs.- Lead or contribute to process improvement and digital transformation initiatives to enhance operational efficiency in alignment with team and business needs, vision and global strategy.- Work as key GRA/GRA excellence or DTRD contact on activities/project managed by other departments as agreed with Function Head and/or GRA LT.- Contribute to Regulatory Clinical Trial Excellence activities, including supporting the coordination of regulatory governance routines and other CRO partnership or internal clinical trial workstreams and initiatives led or supported by Regulatory.4. Quality & Compliance Activities- Contribute to the development and maintenance of Quality Documents, including team-specific and cross-functional SOPs, as well as training materials, to support the effective implementation of disclosure processes and DTRD responsibilities.- Act as Business Process Owner for assigned SOPs.- Provide quarterly compliance and KPI reporting for the assigned portfolio of activities.- Identify, escalate, and report compliance issues and risks, and manage quality events as required.- Participate in audit and inspection readiness activities, acting as a subject matter expert. Serve as the DTRD point of contact during audits and inspections, as needed.5. Regulatory Intelligence & External Engagement- Monitor global regulatory developments and emerging industry standards related to clinical data transparency.- Perform benchmarking and contribute to regulatory watch activities.- Inform team and Function Head of relevant updates and their operational implications.- Represent Ipsen in industry communities, conferences, and working groups to share insights and gather best practices.- Contribute to the development of Ipsen’s thought leadership in transparency through external presentations and publications.HOW - Behavioural Competencies Required)• Ensures Accountability• Communicates effectively• Collaborates• Excellence in execution• Manages Ambiguity• Global perspectiveHOW - Knowledge & ExperienceKnowledge & Experience (essential):• 5-7 years of experience in a transparency/disclosure or regulatory affairs position in the pharma industry.• Comprehensive understanding of the R&D and Global Regulatory Affairs environment, drug development process, and transparency regulations and standards.• Experience in project management, cross-functional collaboration, strategy/policy development, and education on best practices.Knowledge & Experience (preferred):• Experience in one of Ipsen’s therapeutic area: oncology, rare diseases, and neuroscience.• Experience in Anonymization/Access to Information management.• Experience in industry forums.• Experience managing vendors and budget.Education / Certifications (essential):• Bachelor’s or master’s degree in life sciencesEducation / Certifications (preferred):• Master's or PhD in a discipline relevant to the pharmaceutical industry and regulatory affairs/clinical development.Language(s) (essential):• Excellent written and spoken English. #LI-MM1 #LI-hybridWe are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application.