Technical Writer Parenteral Process Validation, Drug Product m/f/d, Basel-StadtThe 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.
Contract duration: 1 year/will be extended due to on-going projects
Location: Basel
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, Basecamp2.0) in support of project teams.
Requirements: - 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
- 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
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