Technical Writer And Document Workflow Manager
Vollzeit @Gi Life Sciences Basel veröffentlicht 10 Stunden agoJob-Beschreibung
The department is responsible for the development of parenteral (biologics and synthetic molecules) drug product formulation and processes from Phase 1 up to commercial launch.
Process validation provides documented assurance that manufacturing processes consistently perform as intended, delivering product quality that complies with Health Authority regulations and safeguards patient well-being.
The Technical Writer and Document Workflow Manager is responsible for authoring and managing the review and approval of process validation and regulatory documents (e.g. IND), 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
Profile
- Bachelor s or Master’s degree in a scientific discipline
- At least 2 years of 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
General Information
- Start date: asap (latest in December 2025)
- Duration: long-term external employment
- Location: Basel (on-site)
- Workload: 100%
If you are interested in this opportunity, please send your CV in English.
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