Medical Devices Development Documentation lead

仕事内容

Make your mark for patientsWe are looking for a Medical Devices Development Documentation lead who is accountable and has excellentdata management andorganizational skills to join us in our Pipeline Device and Delivery Systems team, based either in Braine l’Alleud (Belgium)or in our offices in Bulle (Switzerland) or Slough(England) .About The RoleThis work will be performed in the context of cross-functional technical project and programteams that ensure the design, development, industrialization, and life cycle management ofmedical device and delivery systems to meet the needs of internal stakeholders and ultimately patients.The primary goal of the function is manage documentation for the device and delivery systems development team. The Technical documentation lead will author, review the relevant documents, and generate scientific protocol and reports that support the Design History file, technical documentation and the regulatory license applications and hence must be of a very high standard. All data and reports are written in English and will be verified, cleaned, analysed, and visualized.You will alternately contribute to the preparation of regulatory submissions withbusiness partners by coordinating the elaboration of the relevant documentation and manage the review and approval in the appropriate electronic document management system.The candidate will also contribute to the data integrity review of the relevant technicaldocumentation and CMC sections of regulatory dossiers.Who You’ll Work WithYou will work in a team environment, collaborating with various quality, regulatory, scientific, clinical and manufacturing experts.This position reports to the Head of Devices and Delivery System Portfolio Management and industrial strategy.What You’ll Do

• You analy ze and evaluat e all available development, technical, commercial information and documentation and elaborate recommendation for the development team.
• You manage documentation within UCB’s data systems, evaluating the information, and the consistency of the reports.
• You a uthor device and delivery systems development protocols, reports, risk assessment and templates.
• You v erify data integrity for all relevant documentation.
• You interact with internal and external personnel on many aspects of project and technical documentation related matters
• You l ead cross-functional and matrix teams , a ssess in project team the timelines and deliverables and coordinate and track the relevant documentation accordingly.
• You l iaise with other departments or external partners to ensure documentation meets stakeholder’s needs (quality, regulatory, commercial manufacturing, etc…).

All these activities will be performed in compliance with Quality policies, standards, Quality Management System and with the regulatory requirements for each development phase of the products and devices.Interested? For this role we’re looking for the following education, experience and skills

• You have a master degree in biology, chemistry, or another relevant field of study.
• You have a minimum of 3 years working in the pharmaceutical/biologics/medical industry.
• Operational GMP or quality experience would be a distinct advantage.
• You have a p ractical understanding of Good Manufacturing Practice and ISO13485, 21CFR820, 21CFR210/211, 21CFR4, ISO14971, ICHQ9, MDR requirements.
• You can collaborate in the context of cross-functional internal and external project teams , in a cross cultural environment .
• You have e xcellent planning and organizational skills.
• You are experienced in t echnical writing in English.
• You can communicate technical data to non-specialist audiences from diverse backgrounds, coordinate cross-functional and matrix teams .
• You are accountable for decisions and actions taken.
• . You possess good interpersonal, verbal, and written communication skills and can confidently present information at interdepartmental meetings in English. You e nsure free flow of information throughout the sphere of work.
• You can independently analyses data and information and assess the risks and actions to take within area of expertise, with an extensive quality experience.
• You are able to provide guidance for improvements, corrective and preventive actions related to processes.
• You are able to h elp others solve problems in a creative and practical way through development of solutions.

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 UsUCB 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 for 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.Learn more about sustainability at UCB and how it is integrated into our business approach.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/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.