Expert Medical Writer

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.

 

The Expert Medical Writer will be responsible for writing and overseeing the writing of complex regulatory documents for submission to regulatory authorities in support of drug development and marketing applications.

 

Job Requirements 

 

  • Lead, oversee and coordinate medical writing support for the preparation of regulatory documents in support of marketing applications worldwide, such as CTD summary and overview documents;
  • Act as Programme Medical Writer for complex submissions in Clinical Development
  • Contribute scientifically and strategically to submission teams at the project and/or study team level to facilitate efficient development of high-quality clinical documents for regulatory filing
  • Write and/or review clinical regulatory documents such as CTD Module II summaries and Clinical Overviews, Clinical study reports, and other regulatory documents, as needed, such as Responses to Health Authority questions, 120-day Safety updates, or Paediatric investigational plans
  • Contribute to the planning of data analyses and presentation for Clinical study reports and submission documents; review statistical analysis plans and related documents
  • Act as subject matter expert for regulatory requirements within clinical study and submission teams to ensure compliance of documentation to internal company standards and external regulatory guidelines
  • Effectively collaborate with cross-functional stakeholders, including Therapeutic Area, Clinical Pharmacology, Biostatistics, Drug Safety, Clinical Operations, Preclinical Research, and Drug Regulatory Affairs
  • Work together with the in-house Editorial Group to produce high-quality final documents and ensure timely delivery
  • Drive process and technology improvement and/or cross-functional initiatives related to regulatory writing and documentation
  • Effectively manage the outsourcing of medical writing, as needed
  • Mentor/train less experienced writers

 

Candidate Requirements

 

  • University degree in life sciences or other relevant scientific discipline required. Advanced degree is desirable
  • English mother tongue, or excellent spoken and written English
  • 7+ years of experience as a medical writer in the pharmaceutical industry across several therapeutic areas
  • Well-developed and proven medical writing skills, combined with an ability to interpret and present complex scientific data from different disciplines in a clear, concise format
  • Proven and repeat experience in global registration of drugs, including complex submissions
  • Advanced knowledge of global regulatory environment, including key document requirements, reporting guidelines and approval processes
  • The ability to develop and mentor more junior medical writers
  • The ability to work independently and as part of a team
  • Strong ability to work under pressure, prioritize multiple deadlines and projects and meet challenging deadlines
  • Excellent interpersonal and presentation skills

 

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: 1269

 

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.