Medical Writer

Medical Writer

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.

YOUR RESPONSIBILITIES :

 

Ø Produce documents to support clinical trials and regulatory submissions, in accordance with international regulations and guidelines

Ø Research and recommend external partners, and monitor the quality and progress of sub-contracted writing activities.

Ø Contribute to updating SOPs and templates managed by Scientific Writing, and interface with other departments for process fine-tuning.

Ø Liaised with multi-disciplinary teams to drive the CTD 

Ø Created and developed various regulatory documents

Ø Lead the initiative to develop guidance document for trial results disclosure activities

 

YOUR PROFILE :

 

Ø At least 7 years scientific/medical writing experience in the pharmaceutical industry.

Ø Expertise in clinical eCTD submissions (NDA, BLA)

Ø Excellent scientific/medical writing skills.

Ø Excellent understanding of biostatistics.

Ø Excellent communication skills.

Ø Expert knowledge of regulatory requirements for global submissions.

Ø Proven ability to manage CRO writing activities.

Ø Experience of process improvement initiatives (updating SOPs, templates etc.)

Ø Excellent written and spoken English, french is a must

Marine Dollat mdollat@axepta.com

Specialist Pharmaceutical and Medical Device recruiter and headhunter recruiting in Switzerland and France for the provision of Pharma and Medical Device staff including Quality (GCP, GMP, GLP, GxP, Quality System, Quality Engineer, Quality manager, Quality director and VP level), Regulatory Affairs or Production's position. As specialists in the placement of candidates within the Pharmaceutical Industry, our service is thorough, professional and intelligent. In addition to our permanent and contract recruitment services, we provide proactive search campaigns, advertising campaigns and dedicated account management. If you would like to have a confidential discussion regarding your search for staff or your search for a new position please feel free to contact me directly at mdollat@axepta.com