Description
We are looking for a
Medical Writer (m/f)
Reference: -en
Start: asap
Duration: 9 MM+
Place: in the Basel region
Branch: Pharmazeutische Industrie
Your tasks:
- Write and oversee the preparation of clinical study protocols, clinical study reports, Investigator’s Brochures, clinical pharmacology sections of US and EU clinical trial applications and marketing applications
- Perform macro editing of documents for organization, content, structure, and tone, ensure documents are consistent, and oversee micro editing of documents for punctuation, grammar, sentences, paragraphs, and writing styles
- Coordination of review, revision, quality control, quality assurance, electronic publishing, and approval of documents
- Development and maintenance of standards and processes
- Follow Safety, Health, and environmental policies and procedures
- Performance of other projects and duties as required/assigned
Your qualifications
- Degree in the life sciences field or a related discipline (biology, pharmacy, medicine) on a Masters/PharmD/PhD level
- Profound experience in Medical Writing with experience in Clinical Pharmacology, ideally in writing Phase 1 clinical protocols and CSRs, IBs, PSP and PIPs, and submission documents is highly desirable
- Clinical pharmacology background with experience in Abuse liability document writing preferred
- Functional knowledge regarding world-wide government regulations pertaining to drug development and regulatory documents in support of clinical research
- Proficient in the Microsoft® Office suite of applications/functionality, and in the use of electronic document management systems
- Excellent English skills
Skills:
- Medical writer