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

Nonclinical Medical Writing Expert

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Research & Early Development
Job ID:  69613

Help us transform patients' lives.

At UCB, we put our heart, soul, and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation.  Will you join us in our pioneering adventure?

To strengthen our Research and Pre-Clinical Processes of Early Solutions team, we are looking for a talented individual to fill the position of: Nonclinical Medical Writing Expert, based in either Braine l’Alleud, Belgium, or Slough (London area), UK.

 

As Nonclinical Medical Writing Expert you will have oversight of all the nonclinical medical writing deliverables for a wide variety of regulatory submissions. The NMW Expert is responsible for the preparation of nonclinical scientific documents for submissions to the Regulatory Authorities, and ensures submission-ready, high-quality supporting documentation, including the availability of high-quality SEND datasets, in accordance with agreed submission timelines.  Excellent organisation skills allow effective management of the different nonclinical contributions whilst a flexible and serviceable mindset ensures a collaborative relationship with the different nonclinical areas all the whilst ensuring consistent high quality.

 

You like to work in an environment where your business scope is:

The Nonclinical Medical Writing (NMW) group resides organisationally within “Research and Pre-Clinical Processes” of “Early Solutions” and works to advance the strategy and creation of high-quality nonclinical documents to support efficient and successful regulatory submissions across all regions.

To undertake this role, the NMW Expert has a strong understanding of the core business activity of early phase drug development, of worldwide regulatory submissions supporting clinical trial applications and marketing authorisations, as well as the operational skills and confidence to effectively engage with multiple varied stakeholders and ensure the broad remit of the role.

Under the direction of the NMW Lead, the NMW Expert is responsible for ensuring the operational implementation of the nonclinical contributions to regulatory submissions and reporting to relevant authorities. The role ensures organisational efficiency and compliance with National or International legislation. In addition, the role heavily contributes to business process improvements in response to keeping best practices, changes in business infrastructure, and organisational change management. 

 

You will contribute by:

  • Responsible for the preparation of complex documents such as integrated CTD summaries and IBs, and other core medical writing deliverables. May act as primary author or be available to assist the primary author(s) where necessary. Ensures all documents are authored according to regulatory requirements, internal standards, and with adherence to team expectations.
  • Assumes responsibility for adhering to timelines agreed within the global submission team and must demonstrate organisational and project management skills to effectively manage all nonclinical contributions.
  • Assumes responsibility for the availability of high-quality SEND datasets as required by the Regulatory Agency.
  • Integral member of the global submission team and will participate on multiple cross-functional teams. May act as nonclinical representative.  Ensures appropriate and effective collaboration with all key submission contributors.
  • Serves as expert in the use of UCB authoring tools ensuring accordance with UCB writing styles and regulatory submissions specifications, and as expert in UCB Electronic Content Management Systems.
  • Ensures maintenance of the Nonclinical Medical Writing trackers via a network of internal and external partners.

 

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

Minimum Qualifications:

  • PhD, MSc or BSc in a relevant pharmaceutical development science.
  • Demonstrated awareness (5+ years in an equivalent role) of regulatory requirements for the conduct of nonclinical studies including Good Laboratory Practices (GLPs) and ICH guidelines, relevant regulatory submission guidance documents, and SEND requirements.
  • Confident taking the lead on projects.
  • Proficiency in the use of standard software including Microsoft® Excel, Word, PowerPoint, authoring tools (ideally StartingPoint and PleaseReview), and in Electronic Content Management Systems.

 

Preferred Qualifications:

  • Excellent attention to detail.
  • Demonstrated ability to organize/execute multiple projects in parallel, prioritize work and meet milestones/deadlines.
  • Excellent intra- and inter-departmental written and verbal communication skills, presentation skills desirable.
  • Service mindset.
  • Demonstrate creative yet analytical problem-solving skills to find effective solutions.

 

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.

UCB- Inspired by Patients. Driven by Science. Everything we do starts with a simple question: “How will this create value for people living with severe diseases?” By putting patients at the heart of what 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 and 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.

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. 

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