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.
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.
The perfect candidate has a Bachelor's degree or Master's degree in a scientific discipline and at least 2 years experience within the Parenteral Drug Product aseptic process development and/ or product process validation knowledge including technical terminology. Additionally 2-5 years of experience in technical writing is required, experience in writing of regulatory documents is of advantage.
General Information:
• Start date: asap
• latest Start Date:
• Planned duration: unlimited via Hays
• Workplace: Basel
• Workload: 100%
• Home Office: Yes, 1 day per week
• Team: ca. 5-10 Team Members in Basel
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, 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