For one of our clients, a leading global pharmaceutical company, we are currently looking for a Drug Product Parenteral Process Validation Technical Writer and Document Workflow Manager.
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General Information:
- Start date: ASAP
- Latest possible start date: 01.12.2025
- Duration: unlimited
- Workplace: Basel
- Workload: 100%
- Remote/Home Office: Yes, 1 day per week
- Working hours: Standard
- Department: Global Pharmaceutical Development (MMDP)
About the job:
The department Pharmaceutical Development within Pharma Technical Development 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 is documented assurance of consistent process performance and product quality that meets Health Authority regulations for the patients.
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.
Your Profile:
- Bachelor’s degree or Master's degree in a scientific discipline
- At least 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 is required, experience in writing regulatory documents is of advantage.
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
Sounds interesting? Apply now – we’re looking forward to receiving your applications!
Application Submission Deadline: 12.09.2025
