Documentation Specialist, Drug Regulatory Affairs

Location: 

Basel Area - Allschwil, BL, CH

 

 

About Idorsia Pharmaceuticals Ltd

Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.

In order to achieve this, we will develop Idorsia into one of Europe’s leading biopharmaceutical company, with a strong scientific core.

Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet – the ideal constellation to bringing R&D efforts to business success.

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 600 highly qualified specialists dedicated to realizing our ambitious targets.

 

Job Responsibilities

 

The resource will join the Editorial Group of the Drug Regulatory Affairs Function and will be responsible for the following tasks:

 

  • Proof-reading and copy-editing in English, and formatting in MS Word and PowerPoint
  • 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
  • Updating templates, guidelines and instructions
  • Providing training to clinical authors and other colleagues handling documents

 

 

Candidate’s Requirements

 

  • English mother tongue, or excellent spoken and written English
  • Demonstrated ability to prioritize tasks
  • Good organizational and communication skills
  • Committed attention to detail
  • Excellent MS Office skills (Word, Excel, PowerPoint)

 

Advantageous:

 

  • A background in publishing or editing/proof-reading
  • An academic background (university degree)
  • Knowledge of the pharmaceutical industry and drug development

 

 

 

What Idorsia offers

  • Exciting opportunities  for development and professional growth within our dynamic organization
  • A collaborative and solution oriented enviroment where you can make a difference
  • An innovative and open culture in a truly multicultural environment
  • A competitive salary and generous social benefits

 

 

Work  Location: Allschwil

Country: Switzerland

Business Area: Global Clinical Development

Schedule: Fulltime

Job Type: Permanent

Job ID: 1628

 

If you are interested, please click on apply now.

Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course.

Please note Idorsia operates a strictly-controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.