Stability Technical Writer

il y a 1 mois

Brainel'Alleud, Belgique UCB Temps plein

**Make your mark for patients**

To strengthen our **Analytical Processes & Operations - Stability CoE and Reporting team**, we are looking for a talented individual to fill the position of **Technical Writer**, based in Braine, Belgium.

**About the role**

As Stability Technical writer, you will ensure the preparation of stability reports for UCB products from phase III to commercial phase, in order to meet regulatory requirements and the needs of the various stakeholders within UCB in due time.

**Who will you work with**

As Stability technical writer, you will support the stability Subject Mater Expert in the redaction of the stability reports. You will collaborate with other departments to ensure that reports are released in time following client needs and UCB priorities.

**What will you do**
- Collect analytical data and ensure data integrity control.
- Prepare stability reports.
- Ensure good document management (creation and update, life cycles and compliance with good documentary practices).
- Carry out an assessment of the stability trend using dedicated statistical tools.
- Ensure a double check of the data used in stability reports.
- Ensure the delivery of stability documentation for RA submission in a timely manner.
- Develop expertise in LIMS, IStudyReporter, and other departmental software. Organize, plan, and deliver necessary training to colleagues based on demand for these tools.
- Engage in daily continuous improvement projects, identifying and proposing solutions to minimise functional constraints, with the goal of enhancing the quality and efficiency of departmental output.
- Report any GMP deviations to the Manager.
- Participate in resolving deviations.
- Demonstrate flexibility and proactivity to keep customer satisfaction as a goal.
- Act as a back-up for direct colleagues or the manager, in accordance with the manager's instructions and after having followed appropriate training.

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

- Bachelor's degree preferred.
- Proficiency in Microsoft Office Suit.
- Strong organizational and multitasking skills.
- Excellent communication, interpersonal skills and proactivity.
- Experience in an environment regulated by GMP is a plus.
- Knowledge of statistics (ANOVA, normality, etc.) is an asset.
- Fluent in French and good writing skill in English.

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.

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