Senior Medical Writer - Us

Praxisprecisionmedicines

Remote
Base: $130,000—$150,000 usd; bonus/equity: discret...
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Regulatory compliant documents
Clinical trial transparency
Ich guidelines
** Praxis Precision Medicines is seeking a Senior Medical Writer to join their remote team, responsible for creating high-quality regulatory documents for clinical development programs. The ideal candidate will have extensive medical writing experience, a solid understanding of drug development processes, and a collaborative spirit. **

Job Summary

  • This role is responsible for medical writing activities for one or more clinical development programs at Praxis, as directed by the Associate Director, Medical Writing.
  • Supports documents for regulatory submissions to US and global health authorities, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), protocols, investigator brochures, clinical study reports, briefing documents, regulatory responses to health authority questions, and scheduled reports.
  • At Praxis, we believe that taking care of our people (and *their* people) is important, so we provide a world class benefits package to help you thrive.

Matching Summary

Match Score: 75

** Praxis Precision Medicines is seeking a Senior Medical Writer to join their remote team, responsible for creating high-quality regulatory documents for clinical development programs. The ideal candidate will have extensive medical writing experience, a solid understanding of drug development processes, and a collaborative spirit. **

Salary

Base: $130,000—$150,000 USD; Bonus/Equity: discretionary quarterly bonus, long-term stock incentives and ESPP; Benefits: 99% premium paid for medical, dental and vision plans, life insurance, AD&D, disability benefits, wellness benefit, generous PTO, paid holidays and company-wide shutdowns

Skills & Requirements

Must-have

  • regulatory compliant documents
  • clinical trial transparency
  • ICH guidelines
  • FDA/EU guidance

Nice-to-have

  • CNS and Rare Disease experience
  • passion to deliver quality results
  • highest levels of professionalism

Key Requirements

  • 4+ years of medical writing experience
  • Bachelor’s degree in scientific discipline
  • AMWA certification preferred
  • Experience with Veeva RIM

Work Rights

Not specified

Tailored Resume

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