Regulatory Affairs Documentation Specialist

CK Group are recruiting for a Regulatory Affairs Documentation Specialist to join a Swiss high-potential biopharmaceutical company, specialized in the discovery, development and commercialization of innovative small molecules, with the aim of transforming the horizon of therapeutic options.

The position will be for a 12-month contract, located at the clients office near Basel, the rate for this role will be 52.54CHF per hour.

Job Responsibilities:

• Proof-reading and copy-editing in English, and formatting in MS Word
• Handling the review cycle and tracking versions of draft documents
• Helping to prepare and compile multiple-component reports and submissions
• Transparently communicating document status and progress to stakeholders
• Electronic publishing of final Word documents as eCTD-compliant PDFs using Adobe Acrobat and ISI Toolbox
• Contributing to the update of existing and creating new internal processes, templates, guidelines and instructions
• Providing training to clinical authors and other colleagues handling documents

Requirements:

• Educated to degree level or above in Life science or a relevant field with experience in a Regulatory Affairs role and background in editing/proof-reading orpublishing would be a real advantage
• Excellent spoken and written English
• Good organizational and communication skills
• Committed attention to detail
• Excellent MS Office skills (Word, Excel, PowerPoint)
• Adept at working in a complex environment and learning new processes and systems
• Demonstrated ability to prioritize tasks
• Knowledge of the pharmaceutical industry and drug development is an advantage

Apply:

Entitlement to work in the EEA is essential. Please quote jobreference 56500 in all correspondence.