Regulatory Disclosure and Transparency Expert
7 days ago
We are seeking a highly skilled Data Transparency and Regulatory Disclosure Manager to join our team at Lifelancer. As a key member of our organization, you will be responsible for driving the end-to-end processes of disclosure activities for assigned asset portfolios, ensuring timely and accurate disclosure of Ipsen clinical data on public websites.
Key Responsibilities- Disclosure Management
- Provide specialized knowledge of global disclosure requirements and standards to study/asset teams, ensuring quality and confidentiality of information shared publicly.
- Assess the applicability of clinical studies and submission dossiers for disclosure in accordance with US EU laws and other applicable regulations or policies.
- Ensure study disclosure assessment is tracked and filed, and disclosure roadmap shared with relevant stakeholders in a timely manner.
- Review study protocols, study documents, and product-related documents to identify confidential information and determine its suitability for disclosure.
- Act as DTRD Lead by actively participating in relevant asset or study meetings to raise awareness of requirements and associated disclosure activities.
- Vendor Management and Budgeting
- Be accountable for and oversight work delegated to preferred vendors.
- Plan budget needs per each outsourced activity.
- Ensure optimal outsourcing strategy for disclosure activities by partnership with procurement and in alignment with top management.
- Regulatory Compliance and Awareness
- Perform a regulatory watch on disclosure and transparency requirements from agencies, industry associations, and communities.
- Contribute to relevant industry communities.
- Perform benchmark activities and monitor emergences of standards in this area.
- Participate in congress community calls, conferences, etc.
- Track and inform team management and team members about new requirements, developments, and latest updates as appropriate.
- Global Operational Excellence Support and Transversal Activities
- Participate or lead process improvement and digitalization/automation initiatives that promote strategic disclosures and operational excellence.
- Contribute to the development and maintenance of Standard Operating Procedures and other documentation to ensure effective implementation of processes.
- Mentor more junior staff members.
- Develop a plan for integration of new assets, including transfer of public documents, and ensure its execution.
- Assist senior management in establishing and maintaining governance for data transparency activities at Ipsen, while also ensuring that company policy is in accordance with both regulations and industry standards.
- Actively participate in or lead steering committee meetings, topics as needed.
- Support and/or assume executive delegation of senior management in transversal projects, including but not limited to team scope of activities, such as overseeing EU CTR and championing Data Privacy.
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London, Greater London, United Kingdom Lifelancer Full timeAbout the RoleWe are seeking a highly skilled Data Transparency and Regulatory Disclosure Manager to join our team at Lifelancer. As a key member of our organization, you will be responsible for driving the end-to-end processes of disclosure activities for assigned asset portfolios, ensuring timely and accurate disclosure of clinical data on public...
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London, Greater London, United Kingdom Lifelancer Full timeAbout the RoleWe are seeking a highly skilled Data Transparency and Regulatory Disclosure Manager to join our team at Lifelancer. As a key member of our organization, you will be responsible for driving the end-to-end processes of disclosure activities for assigned asset portfolios, ensuring timely and accurate disclosure of clinical data on public...
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London, Greater London, United Kingdom Lifelancer Full timeAbout the RoleWe are seeking a highly skilled Data Transparency and Regulatory Disclosure Manager to join our team at Lifelancer. As a key member of our organization, you will be responsible for driving the end-to-end processes of disclosure activities for assigned asset portfolios, ensuring timely and accurate disclosure of Ipsen clinical data on public...
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London, Greater London, United Kingdom Lifelancer Full timeAbout the RoleWe are seeking a highly skilled Data Transparency and Regulatory Disclosure Manager to join our team at Lifelancer. As a key member of our organization, you will be responsible for driving the end-to-end processes of disclosure activities for assigned asset portfolios, ensuring timely and accurate disclosure of Ipsen clinical data on public...
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