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Let's push the boundaries together and make the most of your talents!

CDI Document Specialist

Location: 

Raleigh, North Carolina, United States

Job Function:  Clinical Development
Job ID:  68186

Help us transform patients' lives.

At UCB, we put our heart, soul and skills into making a difference for people living with significant unmet needs. Working together, we blend the best of our talents to deliver thoughtful solutions that patients value. Will you join us in this pioneering adventure?

 

 

 

 

To strengthen our Global Clinical Science & Operations (GCSO) department, based our RTP Office in Raleigh, NC we are looking for a talented individual to fill the position of: CDI Document Specialist.

 

As CDI Document Specialist you will manage the collection of documentation for studies, assets and technology solutions across CDI, and the completion of assigned eTMF and other documentation repositories, ensuring submission, audit and inspection readiness

You like to work in an environment where you can:

  • Oversee maintenance of study and asset documentation
  • Develop CDI TMF Plan, conduct ongoing and final QC checks of TMF for sections owned by CDI; providing CRO or Partner with queries/feedback to ensure correctness and completeness of documents and of TMF overall.
  • Maintain eTMF filing of CDI study and asset documentation

 

You will contribute by:

  • Understanding and sharing of project management plans, and ensuring documentation completion is aligned with plans to support completeness, including eTMF
  • Ensuring regulatory submission, audit and inspection readiness
  • Participating in Submission Team Meetings, as necessary, to determine submission document timeline requirements and to ensure necessary documents are implemented in the submission package as required.
  • Working closely with Global Medical Writing colleagues to determine narrative related patient data reports (eCRFs) required for submissions
  • Working closely with CDI colleagues in support of technology solution documentation
  • Contributing to process improvement initiatives and share best practice experience with Line Manager and across CDI as appropriate

 

Interested? For this position you’ll need the following education, experience and skills:

  • Bachelor’s degree
  • 3 or more years of experience in a clinical development environment required.
  • Prior experience in a Data Management related field is preferred
  • Familiarity with document management systems – Veeva Vault experience desired
  • Experience with Clinical trials and related documents is an advantage.
  • Familiarity with reporting and publishing tools
  • Prior knowledge of computer system validation

 

Why you should apply

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

 

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.

 

 

About Us

At UCB, we come together every day to work, laser-focused, on a simple question: How will this create value for people living with severe diseases? By putting patients at the heart of everything we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees worldwide operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases. We are looking for people with passion and empathy who develop a real understanding of patient’s needs and can deliver thoughtful solutions to decisionmakers across the heath care ecosystem.

Curious to know more? Please visit our website www.ucb.com.

 

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.

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