Medical Writer - Braine-l'Alleud, België - UCB S.A.

UCB S.A.
UCB S.A.
Geverifieerd bedrijf
Braine-l'Alleud, België

1 week geleden

Sophie Dubois

Geplaatst door:

Sophie Dubois

beBee Recruiter
Beschrijving

Make your mark for patients


We are looking for a
Medical Writer who is
methodical, detail-oriented, with excellent problem-solving skills to join us in our
Development Solutions team, based in our office in
UK (Slough), Brussels (Braine l'Alleud), Germany (Monheim) or United States (RTP).



About the role


As a
Medical Writer you will prepare and contribute to clinical documents for a regulatory audience, within a team environment, according to UCB SOPs and templates.


Clinical submissions documents in scope include:

Phase 1-4 protocols clinical study reports (CSRs), summary documents, risk management plans, patient narratives, clinical parts of Investigator's Brochures, INDs, agency meeting briefing packages, and other documents that may be assigned.


Who you'll work with

What you'll do

  • Prepare and provide authoring support for clinical submission documents for a regulatory audience, within a team environment, according to UCB SOPs and templates.
  • Manage review and approval process of clinical documents, which includes generating consensus among reviewers, and facilitating discussions in an efficient manner.
  • Manage and perform quality control reviews of clinical documents.
  • Coordinate effectively with Medical Writers and project teams, as needed, to plan timelines and maintain consistency across documents within a project and across indications.
  • Participate in the development of processes and tools related to document authoring, management, and quality control.
  • Travel both domestically and internationally as business necessitates.

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

  • 3 years of experience in scientific or medical writing in the Biopharmaceutical industry. An advanced degree (e.g., MS, PhD, etc.) may be considered in lieu of years of experience.
  • Excellent written and verbal communication skills, mastery of the English language, with a comprehensive understanding of English grammar and punctuation.
  • Basic knowledge of medical, pharmaceutical, and clinical research concepts.
  • Basic understanding of Common Technical Document structure and content and of applicable regulations and guidelines (eg, Code of Federal Regulations, European Directive, and International Council on Harmonisation).
  • Proficiency with Microsoft Office.
  • Excellent problemsolving capabilities, organizational skills, and project management skills.
  • Can adapt to change and manage shifting priorities and timelines.
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 for 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.


Learn more about sustainability at UCB and how it is integrated into our business approach.

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/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.
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