Société : Viroclinics Biosciences Lieu : Ghent Flanders Site source : Talent BE
) company SOPs and developing them into clear and concise procedures.
As ProceduralDocumentTechnicalWriter you review regulatory requirements, and will author, review, edit and perform quality control of documents. This function is responsible for applying appropriate document templates, standards, style and terminology across documents.Your responsibilities will be:
Collaborate with subject matter experts (SMEs) and department heads to write, review or edit comprehensive, accurate, and user-friendly ProceduralDocuments (SOPs, Work Instructions, forms, checklists, manuals, …) in a clear, concise format Coordinates with various departments to assure Proc Docs written are indicative of the process and understandable to the reader Develop a deep understanding of various processes and translate complex information into clear, step-by-step instructions.
Explain complex information into easily understandable language for a variety of audiences, ensuring accuracy and compliance with applicable regulations and company procedures Regularly review and update existing Proc Docs to ensure accuracy and compliance Continuously improve documentation processes and templates to enhance clarity and usability Act as a liaison between different departments to ensure consistency and standardization in documentation practices Lead workflow facilitation of all ProceduralDocuments within the electronic Document Management System Ensure good documentation practices are followed and perform document QC checks.
About You:
You have technical GxP document writing experience in the pharmaceutical, biotechnology, contract research organization or related environment/industry, or recognized equivalent of education and experienceStrong technical comprehension and writing capability with the ability to communicate complex information clearly and concisely.Experience with process mapping and collaborative document development.Excellent attention to detail, logical flow, formatting, and document structure.Ability to work independently and to collaborate effectively with cross-functional teams and build relationships with Subject Matter Experts.Broad knowledge of ICH guidelines, FDA CFRs, EMA directives and other applicable regulatory guidelinesAbility to prioritize tasks, work simultaneously on multiple projects, according to tight timelinesExperience working with an electronic Data Management Systems (Veeva Quality Docs)Proficiency with Microsoft Office and use of electronic document templatesYou are a good and effective communicator.
About usCerba Research is more than just a place of work; it is an organization of committed individuals united by a passion to advance world health.
Serving clients in the global pharmaceutical and biotech industries, we are experts in serological, virological, and molecular approaches and work with a variety of viruses.
Our experts are actively involved in international vaccine and antiviral research programs and is renowned for producing high-quality work that is supported by comprehensive virological and immunological research.
As an equal opportunity employer, Cerba Research is fully devoted to promoting your professional growth and development. By joining us, you will join a diverse, socially active and highly motivated community.
Our dynamic workplace emphasizes teamwork, continual learning, and finding fulfillment in your job while providing plenty of opportunity for skill development, participation in a variety of initiatives, and the possibility to take ownership of your role.
As a reflection of our dedication to excellence, we also place a high priority on your work-life balance and general well-being.
Join our vibrant team that is dedicated to innovation in the life sciences sector, where you can have a positive impact while advancing your career of choice! ViroclinicsBiosciences GhentFlanders
