Document Management Specialist

작업 내용

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 ScopeUnder 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 find effective solutions

We can offer you an informal and open working environment that does not lock scientists into structure and hierarchy. Freedom to take space to pursue your own ideas and make a difference. Opportunity to gain internal and external visibility through interactions with other UCB teams and with world-renown academic investigators. Opportunity to grow both as a drug hunter and leader through participation in project teams and our career/personal development programs.Why you should applyAt 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.RANDATUCBAbout Us.UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 7,600 people in all four corners of the globe, inspired by patients and driven by science.At UCB, everything we do start with a simple question: “How will this create value for people living with severe disease?”. We are on a journey to become the patient-preferred biopharma leader by delivering medicines and solutions that improve lives. We want to ensure the creation of patient value, now and into the future, while contributing to a society where a population of 8 billion people and more should be able to live a good life within limited resources of one planet.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. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.