Manager, Data Transparency and Regulatory Disclosure H/F

at  Ipsen Biopharm Ltd

The following list comprehensively outlines the responsibilities of the DTRD team. The key responsibilities for this position are highlighted in the summary/purpose section, but they may be adjusted based on the individual’s profile and team’s needs.

Oversight of Disclosure Activities and Transparency Lead for Therapeutic Area

• Act as DTRD Lead by:o Assess the applicability of clinical studies and submission dossiers (CTA, MAA, label variations,etc.) for disclosure in accordance with US, EU laws, and other applicable regulations or policies,as well as Ipsen policy.

o Ensure study disclosure assessment is tracked and filed, and disclosure roadmap shared withrelevant stakeholders in a timely manner.
o Review study protocols, study documents, and product-related documents, as applicable, toidentify confidential information and determine its suitability for disclosure.o Actively participating in relevant asset or study meetings to raise awareness of requirementsand associated disclosure activities throughout the study and product life cycle.

o Bring specialized knowledge of global disclosure requirements and standards to study/asset teamsproviding guidance on best practices to ensure quality and confidentiality of information shared publicly, as well as consistency of trial/product information across disclosures.

• Plan and coordinate the end-to-end preparation of some of the following activities, working closelywith cross-functional stakeholders from the asset or study, and the vendor.

o Study information for disclosure on public registries (i.e., ClinicalTrials.gov, EU Clinical TrialRegister, CTIS, EU RWD Catalogue and local register as applicable).
o Clinical trial lay protocol synopses and lay summaries.

o Anonymized/redacted documents or packages for public disclosure and submissions toagencies, for journal publications or ad-hoc requests.

• Contribute to response to questions received by agencies on CTA, Marketing Applications (MA)and other publication or access requests as needed.
• Ensure the maintenance of detailed and up-to-date tracking status for all studies, documents, packagesposted on public websites, as well as for asset-specific commercially confidential information.
• Upload and maintain up to date documentation of disclosure activities in the eTMF and iDOC.
• Manage the shared mailboxes for internal and public enquiries, by ensuring that they aremonitored, and that replies are provided to stakeholders or dispatched as required and incompliance with applicable guidance and regulations.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 withprocurement and in alignment with team/department strategy.Global operational excellence support and transversal activities
• Participate or lead process improvement and digitalization/automation initiatives thatenhance global efficiency and operational excellence for disclosure activities
• Contribute to the development and maintenance of Standard Operating Procedures andother documentation (e.g., Quality Documents, training/guidance material) to ensureeffective implementation of processes.
• Develop plan for integration of new assets and ensure its execution.
• Support and/or take on executive delegation from senior manager in cross-functional activities/projectssuch as:

o Overseeing governance for Ipsen’s data transparency activities, including those managed byother departments (e.g., data sharing, publications), ensuring alignment with regulations andindustry standards.
o Maintaining and enhancing Ipsen.com pages related to data transparency policy, clinical trials,and lay summaries, while collaborating with Digital, Business & Ethics, and other relevantfunctions.o Contributing to EU CTR oversight, maintaining the CTR governance framework, and providingongoing support to study teams.
o Participating in or leading steering committee and kick-off meetings as required.

o Mentoring junior staff members.Awareness of relevant legal, regulatory and industry requirements• Perform a regulatory watch on disclosure and transparency requirements from agencies, industryassociations and communities.

• Contribute to relevant industry communities.
• Perform benchmark activities and monitors emergences of standards in this area.
• Participate to congress, community calls, conferences etc.
• Track and inform team management and team members about new requirements, developments,and latest updates as appropriate.

Knowledge, abilities & experience

Education / Certifications:

• Bachelor’s or master’s degree in life sciences
• Preferred for this role:
• Master or PhD graduated in a discipline relevant to pharmaceutical industry.

Experience:

• 3-5 years of experience in at least one of the following areas: any R&D role related to clinical studies andregulatory submissions, including consulting for R&D projects within the pharmaceutical industry.
• Good understanding of R&D environment and drug development process.
• Demonstrated experience in project management, collaborating with cross-functional teams, andreporting to senior management.
• Experience in developing strategies from multiple inputs, educating on new topics and best practices, andquickly mastering new subjects.
• Previous experience in implementing software/tools and leading cross-functional projects is a plus

Preferred for this role:

• Understand global regulatory framework for clinical trial applications and disclosure requirementsin US and EU, e.g., FDAAA 801 and the Final Rule Final Rule, EU Clinical Trials Regulation No536/2014, Good Pharmacovigilance Practices (GVP) module VIII, EMA Policy 70 and Health CanadaPRCI.
• Familiar with other transparency activities, i.e., publications on journals, plain language summaries, voluntarydata sharing.

Languages:• Excellent written and spoken English.

Soft skills:

• Exceptional time management skills with a proven ability to forecast and manage workload.
• Adaptable working style, capable of prioritizing tasks and performing well under pressure.
• Strong critical and strategic thinking abilities.
• Excellent communication skills, with proficiency in preparing presentation materials that are ready forreview.
• Innovative mindset, bringing new ideas and methods to enhance efficiency, ensure cross-functionalalignment, and promote operational excellence.
• Enthusiastic team player, willing to mentoring junior staff.

Technical skills:

• Proficiency with Microsoft Word, Excel, Power Point, and other Office applications.
• Experience working on platforms like Sharepoint, Drive, Teams etc.
• Ability to work effectively with document management system (eDMS, iDOC) and trial master file (eTMF).
• Familiarity with clinical trial management system(s) (CTMS) and clinical data repository.
• Working knowledge and familiarity with clinical study public registry websites and databases, e.g., USProtocol Registration and Results System (PRS), European Union Drug Regulating Authorities ClinicalTrials Database (EudraCT), EU Clinical Trial Information System (CTIS), EMA Real World Data (RWD)Catalogue.

• 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 withprocurement and in alignment with team/department strategy.Global operational excellence support and transversal activities
• Participate or lead process improvement and digitalization/automation initiatives thatenhance global efficiency and operational excellence for disclosure activities
• Contribute to the development and maintenance of Standard Operating Procedures andother documentation (e.g., Quality Documents, training/guidance material) to ensureeffective implementation of processes.
• Develop plan for integration of new assets and ensure its execution.
• Support and/or take on executive delegation from senior manager in cross-functional activities/projectssuch as

Preferred for this role:

• Understand global regulatory framework for clinical trial applications and disclosure requirementsin US and EU, e.g., FDAAA 801 and the Final Rule Final Rule, EU Clinical Trials Regulation No536/2014, Good Pharmacovigilance Practices (GVP) module VIII, EMA Policy 70 and Health CanadaPRCI.
• Familiar with other transparency activities, i.e., publications on journals, plain language summaries, voluntarydata sharing