Senior Medical Writer

  • Salary: 71-80 CHF per hour
  • REF Number: 00047638
  • Consultant: Jocelyn Blackham
  • Contact: 0041 (0) 782 516 595
  • Date Published: 06.02.2020
  • Sector:
  • Location: Basel Area
  • Discipline: Clinical - Medical Writing

CK QLS are recruiting for a Senior Medical Writer to join a rapidly growing biopharmaceutical company at their site based in Basel-Landschaft on a on a contract basis for until the end of 2020, with the possibility of extension.

Company: This company is a rapidly growing biopharmaceutical company that is discovering, developing innovative medicines.

Location: This Senior Medical Writer role will be based at our clients site in Allschwil just outside of Basel.

Senior Medical Writer Role:

  • Write and manage review and approval of clinical and regulatory documents, such as clinical study reports (CSRs) and high-level clinical summaries and overviews.
  • Contribute scientifically and strategically at the project and/or study team level to facilitate efficient development of high-quality clinical documents for regulatory filing, e.g. provide input on pooling strategy, provide content expertise and guidance, and advise regarding regulatory requirements and ICH guidance.
  • Contribute to the planning of data analyses and presentation for CSRs and submission documents; review statistical analysis plans.
  • Support writing of responses to health authority questions, as required.
  • Work together with the in-house Editorial Group to produce high-quality documents in compliance with internal company standards and external regulatory requirements.
  • Participate in process and technology improvement initiatives related to regulatory writing and documentation.
  • Manage the work of external medical writers, as needed.
  • Mentor/train less experienced writers.

Your Background:

  • University degree in life sciences or other relevant scientific discipline required. Advanced degree is desirable.
  • Fluent English spoken and written skills.
  • Previous experience in writing regulatory documents.
  • 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 global regulatory submission experience.
  • Excellent knowledge of global regulatory environment, including key document requirements, reporting guidelines and approval processes.
  • Strong ability to work under pressure and prioritize multiple deadlines and projects.
  • Ability to work independently and as part of a team.
  • Attention to detail.
  • Excellent interpersonal and communication skills.

Apply: For more information or to apply for this Senior Medical Writer, please contact Jocelyn on 0041 (0) 782 516 595 or email applicationsqls@ckqls.ch. Please could you send any correspondence in English. Please quote reference 47182 in all correspondence.

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