Expert Regulatory Writer
Novartis Pharmaceuticals Corporation
East Hanover, NJFull-time$200K/yrSeen 1 day agoSeen in employer's feed 1 day ago
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Requirements
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Job overview
The Expert Regulatory Writer writes, reviews, and manages clinical and safety documentation for regulatory submissions supporting marketing applications. The role provides documentation consultancy to other functions, mentors less experienced writers, and leads writing teams for complex submissions. It also contributes to messaging and pooling strategy, guides clinical content for the CTD, and ensures documentation complies with company standards and regulatory guidelines.
Skills & qualifications
Skills
Qualifications
Full job description
Experience Required
6 years of experience in the job offered or related position.
Minimum Education Required
Master's degree in Biology, Cell Biology, Neuroscience, Pharmaceutical Science, or a related field.
Compensation
$200,300.62 / Yearly
Hours Per Week
40
Number Of Positions
1
Job Description
Write, review and/or manage the production of high quality clinical and safety documentation
for submission to regulatory authorities in support of marketing applications; provide
authoritative documentation-related consultancy to other line functions; coach/mentor and/or
train less experienced writers; lead writing team for complex submissions, while actively
contributing to key messaging and pooling strategy; provide expert content guidance for
clinical portions of the CTD; and ensure compliance of documentation to internal company
standards and external regulatory guidelines.
Place of Work
On-site
Requisition ID
#RP775407
Job Type
Full Time
Application Email
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