Documentation Specialist in Regulatory Affairs
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CTC is a specialized search and recruitment partner for the Life Sciences industry, serving clients and candidates since 1997. We enable careers by connecting talented professionals with meaningful opportunities, and we support our clients in engaging, retaining, and developing the right talent when needed.
Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking a:
Documentation Specialist in Regulatory Affairs
for a contract of 12 months, based in Basel.
Main Responsibilities
* Proof-reading and copy-editing in English, and formatting in MS Word
* Handling the review cycle and tracking versions of draft documents
* Preparing and compiling multiple-component reports and submissions
* Communicating document status and progress to stakeholders
* Electronic publishing of final Word documents as eCTD-compliant PDFs using Adobe Acrobat and ISI Toolbox
* Updating of existing and creating new internal processes, templates, guidelines and instructions
* Providing training to clinical authors and other colleagues handling documents
Qualifications and Experience
* Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required
* English mother tongue
* Experience in editing/proof-reading or publishing
* Knowledge of the pharmaceutical industry and drug development a plus
Seniority level
* Associate
Employment type
* Contract
Job function
* Writing/Editing, Art/Creative, and Advertising
Industries
* Pharmaceutical Manufacturing and Biotechnology Research
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