Medical Writer

Vor 3 Tagen

NeuUlm, Deutschland Nuvisan GmbH Vollzeit

**TASKS**

Medical Writing as part of clinical development projects from study planning through to submission to health authorities

Preparation and review of clinical study documents (e.g., clinical study protocol, safety report, information and informed consent form, clinical study report, investigator’s brochure)

Responsible for the content and technical quality as well as for the timely preparation of clinical documents

Quality control of clinical documents

Participation in the creation and revision of SOPs

Coordination of internal and external review cycles

**QUALIFICATIONS**

A completed Master or University degree in medicine, pharmacy, biology, biochemistry or other life science.

Ideally experience in preparing medical writing documents for medicinal product trials.

Expertise of clinical development processes as well as the ability to quickly grasp new medical concepts.

Knowledge in pharmacokinetics and statistical evaluation of clinical trials

Excellent skills in compiling complex data and providing context.

Excellent command of spoken and written English and German (preferably mother tongue or equivalent).

Safe handling of standard software, MS Office and Documentum systems.

Very good communication skills

Assertiveness and high social competence

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