Medical Writer (m/f)

REFERENZNUMMER:

354368/11

IHRE AUFGABEN:

-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

IHRE QUALIFIKATIONEN:

-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

WEITERE QUALIFIKATIONEN:

Medical writer