Manager, Data Transparency And Regulatory Disclosure

Summary / purpose of the position

In collaboration with the DTRD and cross-functional teams, the DTRD Manager is responsible for driving the end-to-end processes of disclosure activities for assigned asset portfolio/s that result in timely and accurate disclosure of Ipsen clinical data on public websites, tracked appropriately.

The DTRD Manager is the point of contact for study teams, asset leads and strategic partners to support with decisions and operations related to any data disclosure/sharing activity associated with regulatory submissions or as per agencies' requests and local requirements.

In this new position, the DTRD Manager applies strong project management expertise and contribute to functional excellence through processes and technologies changes. The role involves driving the implementation of strategies that aim to maximize global efficiency and strategic alignment of IPSEN disclosure activities with external communication across therapeutic areas.

The mission entails imparting knowledge to key stakeholders on best practices and fostering a transparency culture throughout the company by reinforcing interactions with key partners.

Main responsibilities/ job expectations

The list below is an exhaustive list of potential activities and will be adjusted according to the profile.

Management of routine disclosure activities

• Bring specialized knowledge of global disclosure requirements and standards to study/asset teams providing guidance on best practices to ensure quality and confidentiality of information shared publicly, as well as consistency of trial/product information across disclosures.
• 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.
• 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, as applicable, 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 throughout the study and product life cycle.
• Plan and coordinate the end-to-end preparation of the following activities, working closely with cross-functional stakeholders from the asset or study, and the vendor.

1. o Study information for disclosure on public registries (i.e., ClinicalTrials.gov, EU CTR, CTIS, EU PAS Register and local register as applicable).
2. o Clinical trial lay protocol synopses and lay summaries.
3. o Anonymized/redacted documents or packages for public disclosure and submissions to agencies, for journal publications or ad-hoc requests.

• Contribute to response to questions received by agencies on Clinical Trial Applications, Marketing Authorization Applications and other regulatory procedures as needed.
• Ensure the maintenance of detailed and up-to-date tracking status for all studies, documents, packages posted 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 eDMS.
• Manage the shared mailboxes for internal and public enquiries, by ensuring that they are monitored, and that replies are provided to stakeholders or dispatched as required and in compliance 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 with procurement and in alignement top management.

Awareness of relevant legal, regulatory and industry requirements

· Perform a regulatory watch on disclosure and transparency requirements from agencies, industry associations 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.

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 (e.g., Quality Documents, training/guidance material) to ensure effective

implementation of processes.

· Mentors more junior staff members.

· Develop 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 to 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.

Knowledge, abilities experience

Education / Certifications:

· Bachelors or masters degree in life sciences

· Preferred for this role:

· Master or PhD graduated in a discipline relevant to pharmaceutical industry.

Experience:

· 3-5 years in at least one of the following areas: clinical data disclosure/transparency, regulatory affairs, clinical operations, or consulting for RD projects in the pharmaceutical industry.

· Good understanding of RD environment and drug development process.

· Well-versed in preparing or reviewing clinical and/or regulatory documents and/or experience in summarizing scientific information.

· Proved experience in project management.

Preferred for this role:

· Understand global regulatory requirements and guidance for clinical trial disclosure, e.g., FDAAA 801 and the Final Rule Final Rule, EU Clinical Trials Regulation No 536/2014, Good Pharmacovigilance Practices (GVP) module VIII.

· Understand Global Regulatory Affairs environment, in particular Clinical Trial Application and Marketing Authorization Applications s and associated transparency regulations (EMA Policy 70 and Health Canada PRCI).

· Familiar with other transparency activities, i.e., publications on journals, plain language summaries, voluntary data sharing.

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 electronic document management system (eDMS) 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., ClinicalTrials.gov (PRS), EU CTR (EudraCT), EU Clinical Trial Information System (CTIS).

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