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Job details

REMOTE Contract // Regulatory Editing/Publishing opportunity with a well-funded Rare Disease biotech

This Jobot Job is hosted by Jeff Barron

Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume.

Salary $40 - $80 per hour

A Bit About Us

Our client is a publicly traded clinical-stage biotech with a focus on rare disease and orphan drugs in endocrinology. The company's robust pipeline and successful Ph II/III trials have led to strong stock performance and a robust financial runway for continued compound development & pathway to commercialization.

Why join us?

• 100% Remote role
• Incredible company culture and proven management team
• Make a big impact on small patient populations through the development and approval of orphan drug candidates
• 20 hours per week

Job Details

Here's what you'll do

• Perform QC review of clinical and regulatory documents for submission to regulatory agencies in accordance with company-specific SOPs, templates, style guide, and QC processes within established timelines
• Assist in the review, development, and maintenance of document templates, work instructions, and standard operating procedures, as needed
• Provide editorial and formatting support, with a focus on clarity, accuracy, and consistency, and ensure that format and content comply with applicable regulations
• Identify and appropriately communicate risks associated with document QC and propose mitigation plans
• Ensure that the format and content of clinical and regulatory documents comply with applicable submission formatting regulations

Here's what you'll need

• Bachelor's Degree preferred
• Work independently to meet submission timelines
• Strong user of MS Office (Word, Excel, PowerPoint)
• 3+ years of document QC experience in the biopharmaceutical industry.
• 3+ years of Regulatory editing and publishing experience within biopharma, medical device, IVD, or CRO industries (protocols, amendments, IBs, CSRs, INDs, NDA modules)

Interested in hearing more? Easy Apply now by clicking the "Apply" button.

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