Data Transparency Lead (m/f/d) (Clinical Trial) (US)

Make your mark for patients

We are looking for a Data Transparency Lead (m/f/d) who is accountable, strategic, and collaborative to join our Global Medical Writing team, based in our office in Raleigh, US.

About the role

As the Data Transparency Lead (m/f/d), you will be responsible for overseeing the global delivery of data transparency activities in compliance with transparency requirements. This includes ensuring that all transparency processes - such as the preparation of plain language summaries, Policy 0070 submissions, Health Canada PRCI submissions, and data sharing operations - are aligned with UCB's policies and regulatory requirements. You will drive the development of best practices and ensure transparency activities are carried out consistently, ethically, and in accordance with global standards.

Who you'll work with

You will collaborate closely with teams across Clinical Project Management, Biostatistics, Medical Writing, Regulatory Affairs, and Patient Safety. You will also work with both internal stakeholders and external vendors to maintain high standards of compliance and data integrity.

What you'll do

• Represent the organization as the data transparency and anonymization point of contact, providing input and guidance on best practices.
• Lead and/or support the preparation of data and documents for transparency, disclosure, and data sharing.
• Lead the development of new data anonymization techniques in collaboration with service providers.
• Oversee the anonymization and redaction service provider, ensuring compliance with performance metrics and regulations.
• Provide anonymized clinical study data to qualified recipients within approved platforms.
• Assist with results and registration process tasks as needed.
• Support the Disclosure, Quality Control, Medical Writing Teams as needed
• Perform other tasks as assigned.

Interested? For this role we're looking for the following education, experience, and skills:

• Bachelor's degree in a relevant field required; a Master's degree is preferred
• Proven experience in managing global data transparency and disclosure or similar roles
• In-depth knowledge of clinical study transparency and data anonymization regulations
• Knowledge of disclosure requirements including registry and results posting
• In-depth knowledge of clinical development and clinical trials
• Knowledge of clinical and regulatory documents and submissions
• Excellent organizational and project management skills
• Ability to collaborate with cross-functional teams and manage global partnerships
• Experience with an Electronic Content Management systemAre you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!

This position's reasonably anticipated base salary range is $121,000-$160,000 annually. The actual salary offered will take into account internal equity and may also vary depending on the candidate's geographic region, job-related knowledge, skills and experience, among other.

If you are interested to learn more about R&D within UCB, please find more information here R&D at UCB.

RANDATUCB

Are you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!

About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.

Why work with us?
At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equitable opportunities to do their best work. We 'go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.