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Medical Writer - Drug Safety

Newark Metro Area, NJ

Job Type: Scientific Job Number: JN -102019-25779 Region: Newark Metro Area

Job Description



Reporting to the Associate Director, Global Drug Safety & Risk Management

Aggregate Safety Reporting , the primary role of the ASR Medical Writer is to provide formatted Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), Addendum Reports and US Periodic Safety Reports (PSRs) in publishing-ready format.

Qualification/Experience Required:

Minimum of PharmD, MS, or the equivalent combination of relevant education and professional experience (BS with appropriate experience will be considered)


Must have experience writing ASR and DSUR reports

Minimum of five years relevant experience in pharma/biotech writing, preferably in PV writing

Experience with safety databases (ARISg or similar) and their output

Expertise in Medical and/or Scientific Writing

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