Senior Manager, Data Transparency & Regulatory Disclosure

Title:

Senior Manager, Data Transparency & Regulatory Disclosure

Company:

Ipsen Biopharm Ltd

 

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

 Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Job Description:

Senior Manager, Data Transparency and Regulatory Disclosure

Global Regulatory Affairs Excellence, R&D

Director, Head of Regulatory Clinical Trial Excellence & Data Transparency

Paris, France & London, United Kingdom

WHAT - Summary & Purpose of the Position

Reporting 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 Competencies

1.          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 perspective

HOW - Knowledge & Experience

Knowledge & 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 sciences

Education / 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-hybrid

We 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.