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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?

• 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
• 100% Remote role

Job Details

Here's what you'll do

• 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
• Assist in the review, development, and maintenance of document templates, work instructions, and standard operating procedures, as needed
• 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
• 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
• 3+ years of Regulatory editing and publishing experience within biopharma, medical device, IVD, or CRO industries (protocols, amendments, IBs, CSRs, INDs, NDA modules)
• Work independently to meet submission timelines
• Strong user of MS Office (Word, Excel, PowerPoint)
• 3+ years of document QC experience in the biopharmaceutical industry.

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

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