Description
We are looking for a
Medical Writer (m/f)
Reference: -en
Start: asap
Duration: 24 MM++
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Erzeugnissen
Your tasks:
- Act as a Transparency Specialist to ensure compliance with clinical report publication requirements under EMA policies and Clinical Trial Regulation
- Write clinical study reports and other documents as required (Medical writing includes the writing of multiple Phase 2 and/or phase 3 clinical study reports)
- Support and contribute to educational activities
- Oversee evolving regulatory requirements and serve as a contact point and expert
- Identify potential tools and manage external vendors providing specialized anonymization services
- Create and maintain Standard Operating Procedures (SOPs) and working instructions
Your qualifications
- Experienced Medical Writer with demonstrated Life Sciences industry background
- Bachelor degree in Life Sciences or equivalent educational background in combination of the required skill set
- Experience in clinical report publication requirements under EMA policies and the Clinical Trial Regulation
- Proficiency in the writing of clinical study reports
- Profound user skills regarding MS Office
- Excellent, up to native-level English language skills, in both verbal and written form
- Profound professional medical writing experience within the pharmaceutical or associated industries
- Understanding of the regulatory guidelines associated with clinical study reports etc. (e.g. ICH E3, ICH M4E)
Skills:
- Medical writer
Keywords: Medical Writer