Work Selection AG As a first-tier supplier to our renowned business client, F. Hoffmann-La Roche Ltd. based in Basel we are looking for a motivated and committed Technical Writer, for a 12 month assignment with the option to extend. The Technical Writer and Document Workflow Manager is responsible for authoring and managing the review and approval of process validation and regulatory documents (IND and IMAs). Converts scientific data into clear, scientifically sound, well-structured scientific internal and regulatory documents intended for global health authorities and stakeholders, which are based on respective model documents. Understands purification process development and has an excellent knowledge of purification process validation. Tasks & Responsibilities - Independently write, review and format process validation protocols and reports as well as regulatory documents - Interpret and understand process validation data as needed to prepare respective documents - Compile and organize the supporting data and documentation to ensure that accuracy, completeness, and consistency are maintained in the final PV package and regulatory documents (Compliance of internal and external documents) - Work on multiple projects and/or project teams in parallel (dependent on complexity and time commitment for each project) ensuring timeline adherence in collaboration with project managers - Coordinate assigned Process Validation (PV) study documents and regulatory submission dossier sections for project teams. - Apply IT solutions/tools and act as ?Superuser? to manage process knowledge and document workflow (e.g., Veeva Quality Docs, Veeva RIM, eVAL Roche, Basecamp2.0) in support of project teams. Must Haves - Bachelor's degree or Master's degree in a scientific discipline - 2+ years experience within the Parenteral Drug Product aseptic process development and/ or product process validation knowledge including technical terminology - 2-5 years of experience in technical writing, experience in writing of regulatory documents is of advantage - Excellent command of English is required - Superior working knowledge and affinity to IT tool to manage text processing, flow diagram and spreadsheet applications as well as validation documentation workflows - Ability to learn fast, grasp the essence of a strategy or a story quickly to convert relevant scientific data/information into high quality summaries and reports - Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects - Ability to take high degree of initiative and demonstrates motivation to work independently and be a self-starter - Team and solution oriented with flexibility in prioritization Benefits - Enjoy exclusive discounts all year round at renowned retailers and over 200 top brands - Benefit from fleet discounts when purchasing a new car or receive consistent fuel discounts with our fuel card - Be part of one of the most prestigious pharmaceutical companies and actively shape the future of healthcare - Work on a state-of-the-art campus with green spaces, social areas, and an inspiring atmosphere - Take advantage of attractive fitness and swimming pool offers or use the gaming room as a creative retreat Have we sparked your interest? Don't hesitate and submit your complete application documents online today. We look forward to hearing from you! Wir wertschätzen Vielfalt und begrüssen daher alle Bewerbungen ? unabhängig von Geschlecht, sozialer Herkunft, Religion, Alter und Identität. Zur leichteren Lesbarkeit und besseren Verständlichkeit verwenden wir nur eine Gender-Form. Selbstverständlich sind im jeweiligen Kontext alle Genderformen gleichermassen gemeint. Temporär 100% Mitarbeiter Branche: Anderes Funktion: Anderes