Research and Pre-Clinical Study Documentation Specialist (UCB - Braine L'alleud)
Offre d'emploi mise en ligne le 17/02/2020
To strengthen our Research and Pre-Clinical Processes, Non-Clinical Submission Excellence Group, we are looking to fill the position of:Research and Pre-Clinical Study Documentation Specialist.
The Research and Pre-Clinical Study Documentation 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 Research and Pre-Clinical Study Documentation Specialist has a strong understanding of the core business activity of Early Solutions as well as operational skills in order to effectively engage with multiple varied stakeholders and ensure the broad remit of the role.
Under the direction of the E-Content Management and Business Process Improvement Lead, the Research and Pre-Clinical Study Documentation 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.
- Study Documentation Operational Management – Manage day-to-day operations of regulated and non-regulated documents, non-clinical study-related documents intended for submission and documents for regulatory submissions, this includes:
- Records management/Workflow management/Template management, act as an ECMS (Electronic Content Management System) Business Administrator, a Template Coordinator and a PleaseReview (Workflow management tool) key-contact.
- Technical Support:
- Document formatting, act as a StartingPoint expert (Authoring tool), in accordance with UCB Writing Styles and publishing 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
- Back up Archiving activities
- Support and actively contribute to the Business Process Improvement (BPI) initiatives in order to streamline, simplify, standardize e-content management processes and related procedures
- 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 ECMS (Electronic Content Management Systems, e.g. Source Submissions Veeva Vault, StartingPoint)
- 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
- Excellent planning and organizational skills
- Priority management, ability to work on multiple objectives
- Analytical and process minded
- Excellent attention to detail
- Extensive computer skills
- Customer and quality focused
- Ability to work alone and also an integral member of the Non-Clinical Submission Excellence team
- Service management, demonstrate creative problem-solving skills to find effective solutions