Document Management Specialist

il y a 20 heures

Brainel'Alleud, Belgique UCB S.A. Temps plein

**Make your mark for patients.**

We’re here because we want to build the future and transform patients’ lives for the better.

At UCB, our people are our experiences and achievements, our passion and drive. That’s why we’re looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.

An exciting journey lies ahead. Will you join us in pushing the boundaries of what’s possible?

**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 **Research and Pre-Clinical Processes** team, we are looking for a talented individual to fill the position of **Document Management Specialist, **based in Braine-l’Alleud, Belgium.

The Document Management Specialist provides business and technical expertise and drives for excellence within operations, processes, documentation, and compliance with R&D regulations within Early Solutions, with global reach, challenge and influence.

To undertake this role, the Document Management Specialist has a strong understanding of the core business activity of Early Solutions, Non-Clinical function, as well as operational skills to effectively engage with multiple varied stakeholders and ensure the broad remit of the role.

**Business Scope**:
Under the direction of the E-Content Management and Business Process Improvement Lead, the Document Management Specialist is responsible for the operational management of regulated and non-regulated documents. The role ensures organizational efficiency and compliance with national or international legislation.

The role may also involve working closely with the Non-Clinical Medical Writing Services Lead, supporting procedures and contributions to regulatory submissions.

The Document Management Specialist contributes to the effectiveness and efficiency of the team and the optimization of the quality of our Study Document Management business processes.

**Main accountabilities**:

- Study Documentation Management - Manage day-to-day operations of regulated and non-regulated documents, this includes:

- Records/Workflow/Template management, act as an ECMS (Electronic Content Management System) Business Administrator
- Technical Support:

- Document formatting in accordance with UCB Writing Styles and formatting standards for regulatory submissions
- Work closely with internal and external SPARK (Submission Portfolio and Regulatory Knowledge Management) and Submission-Publishing teams to ensure documents are correctly formatted and undergo their appropriate Submission-Readiness (SR) checks in a timely manner, and subsequently check publishing output
- Provide support and training to in scope users on e-content management systems and related business procedures
- Maintain business documentation
- Back up Archiving activities
- Actively contribute to the Business Process Improvement (BPI) initiatives to streamline, simplify, standardize e-content management processes and procedures

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

- Scientific background
- Experience of working in pharma industry, knowledge of pharmaceutical development processes, conduct of non-clinical studies and scientific deliverables
- Proven experience under GxP (GLP, GCP) regulations
- Proven experience in database management, ECMS (Electronic Content Management Systems, e.g. Veeva Vault)
- Experience of pharmaceutical submission-related activities and an awareness of the latest standards required for regulatory submissions including international guidance’s published by the regulatory agencies such as FDA, EMA

**Competencies**:

- Excellent planning and organizational skills
- Analytical, sequential and process compliance minded, attention to detail
- Excellent technical skills, extensive computer skills
- Excellent communication skills (English, French)
- Priority management, ability to work on multiple objectives
- Customer and quality focused
- Ability to work alone and as an integral member of the team
- Service management, demonstrate creative problem-solving skills to fi

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