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Company

Jobot

Address Chicago, IL, United States
Employment type CONTRACTOR
Salary
Category Nanotechnology Research,Research Services,Biotechnology Research
Expires 2023-05-21
Posted at 1 year ago
Job Description
Want to learn more about this role and Jobot? Click our Jobot logo and follow our LinkedIn page!


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?


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


Job Details


Here's what you'll do


  • 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
  • Ensure that the format and content of clinical and regulatory documents comply with applicable submission formatting regulations
  • 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
  • Identify and appropriately communicate risks associated with document QC and propose mitigation plans


Here's what you'll need


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


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


Want to learn more about this role and Jobot?


Click our Jobot logo and follow our LinkedIn page!