Medical Writer

Reference Number: 896198-W
Type of placement: Contract, until the 31st of December 2019
Location: CH, NW

Introduction:

Our client, a dynamic global bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a Medical Writer to start as soon as possible on a contract until the 31st of December 2019 based in the Basel area.

The ideal candidate should have at least 5 years of experience in years of previous experience in writing regulatory documents.

Main Responsibilities:

  • Write and review clinical regulatory documents such as clinical study reports, investigator’s brochures and CTD Module II Summaries, in collaboration with Regulatory Project Managers,Clinical Science Leaders, and the International Project Team.
  • Contribute scientifically 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;
  • As required, support writing of responses to health authority questions;
  • Assist in the preparation and review of statistical analysis plans.
  • Work together with the in-house Documentation Group to produce high-quality documents in compliance with regulatory requirements.
  • Manage external medical writing services.

Qualifications and Experience:

Qualifications and Experience:

  • A degree in life sciences (BSc and/or MSc/PhD)
  • Ideally English native speaker
  • At least 5 years of professional experience as a a medical writer in the pharmaceutical industry across several therapeutic areas
  • Previous experience in experience in writing protocols and clinical study reports (CSRs) 
  • Strong interpersonal and negotiation skills, ability to work effectively as part of a cross-functional team, comfortable giving presentations and providing training
  • Relevant working/residency permit or Swiss/EU-Citizenship required.

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