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

Senior Medical Writer

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Clinical Development
Job ID:  64826

Senior/Principal Medical Writer

UCB – Inspired by patients. Driven by science.

Help us transform patients’ lives.

About UCB

 

At UCB, we put our heart, soul and skills into making a difference for people living with severe diseases. We look to transform patients’ lives by pushing the boundaries of what is possible. With us, our talent makes the most of who they are, unlocking innovation and setting new standards for patients.

 

Everything we do starts with a simple question: “How will this make a difference to the lives of people living with severe diseases?” And to find the answers, we connect globally with patients and their families living with the physical and social burdens of severe disease. These connections give us new perspectives, drive our innovation, and offer a hope for a new generation of therapies that will help to transform lives.

 

To strengthen our Global Clinical Science & Operations Group, we are looking to fill the position of: Senior/Principal Medical Writer.

 

About the Role

You will be responsible for:

  • Ensuring critical review and interpretation of clinical efficacy and safety data for appropriate medically relevant and SOP/GCP/ICH compliant presentations.
  • Preparing clinical submission documents for a regulatory audience according to UCB SOPs and templates.
  • Managing review and approval process of clinical submissions documents, which includes authoring documents, generating consensus among reviewers and facilitating discussions.
  • Providing process, content, and submission/document planning expertise to Clinical Submission Team, Clinical Satellite Team and Clinical Trial Team.
  • Advising the team on resource utilization, efficiencies, timelines and interdependencies.

 

About You

You should have:

  • A relevant degree coupled with expert knowledge of medical, pharmaceutical, and clinical research concepts.
  • A high degree of familiarity with statistical and data output alongside prior CSR/Summary Document generation experience.
  • Excellent knowledge of the methods, techniques, and procedures of medical writing tasks.
  • Previous experience with submissions in CTD format.
  • Knowledge of eTechnology related to regulatory submission activities (eCTD, EDMS, Life Cycle Management).
  • A detailed understanding of applicable regulations, Common Technical Document structure and content, including CSR and summary document content.
  • An understanding of applicable regulations and guidelines.

 

UCB – The Facts

With more than 7500 employees in approximately 40 countries, we are a global biopharmaceutical company headquartered in Brussels, Belgium which invests in cutting-edge scientific research to meet unmet patient needs. A few other reasons that make UCB an amazing place to work:

  • Promising pipeline that includes several novel molecules and no major patent expiration in the next decade;
  • About 25% of 2016 revenue reinvested into Research & Development
  • 2018 Key Financials: €4.6 billion global revenue Specialties: Neurology, Immunology


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