Medical Writer – Regulatory Documents

For our client, a leading pharmaceutical company based in Switzerland, we are looking for a

Medical Writer – Regulatory Documents 80% - 100% (Ref. Nr. 3016)
CTD Module 2 and 5 expertise

Your main tasks

• Author clinical study reports (CSRs), investigator brochures, and CTD Module 2 summaries.

• Write and review clinical overview, clinical summary, and nonclinical written summaries.

• Ensure consistency and quality of medical writing across regulatory submissions.

• Collaborate with clinical, biostatistics, and regulatory teams on document strategy.

• Manage medical writing timelines and coordinate with external writing vendors.

Your profile

• PhD or Master's in Life Sciences, Medicine, or Pharmacy.

• 4-7 years of medical writing experience in the pharmaceutical industry.

• Extensive experience with ICH CTD format and regulatory submission documents.

• Strong command of scientific English with excellent writing and editing skills.

• Knowledge of AMWA/EMWA medical writing guidelines.