My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their regulatory team in Switzerland, Vaud Canton.
Due to this growth my client is looking for a Medical Writer with experience working on global level.
Produce documents to support clinical trials and regulatory submissions, in accordance with international regulations and guidelines
Research and recommend external partners, and monitor the quality and progress of sub-contracted writing activities.
Contribute to updating SOPs and templates managed by Scientific Writing, and interface with other departments for process fine-tuning.
Liaised with multi-disciplinary teams to drive the CTD
Created and developed various regulatory documents
Lead the initiative to develop guidance document for trial results disclosure activities
At least 7 years scientific/medical writing experience in the pharmaceutical industry.
Expertise in clinical eCTD submissions (NDA, BLA)
Excellent scientific/medical writing skills.
Excellent understanding of biostatistics.
Excellent communication skills.
Expert knowledge of regulatory requirements for global submissions.
Proven ability to manage CRO writing activities.
Experience of process improvement initiatives (updating SOPs, templates etc.)
Excellent written and spoken English, french is a must