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Projektbeschreibung
REFERENZNUMMER:
294170/11
IHRE AUFGABEN:
-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
IHRE QUALIFIKATIONEN:
-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)
WEITERE QUALIFIKATIONEN:
Medical writer
294170/11
IHRE AUFGABEN:
-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
IHRE QUALIFIKATIONEN:
-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)
WEITERE QUALIFIKATIONEN:
Medical writer
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges