Medical Writer (m/f)

REFERENZNUMMER:

284350/11

IHRE AUFGABEN:

-Act as a Transparency Specialist to comply with the clinical report publication requirements under EMA Policies and the Clinical Trial Regulation
-Writing clinical study reports and other documents as required
-Supporting and contributing to educational activities
-Overseeing evolving regulatory requirements and serving as a contact point and expert
-Identifying potential tools and managing external vendors providing specialized anonymization services
-Creating and maintaining Standard Operating Procedures and Working Instructions

IHRE QUALIFIKATIONEN:

-Experienced Medical Writer with demonstrated Life Sciences industry background
-Bachelor degree in Life Sciences or equivalent educational background with the combination of the required skills
-Experienced 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

WEITERE QUALIFIKATIONEN:

Medical writer, Medical affairs manager, Regulatory affairs assistant