Medical Writer, Regulatory Affairs

  • Location: Malvern, Pennsylvania
  • Type: Direct Hire
  • Job #27149

Why open:         Expansion and growth of the company

Base Range:       $95k-$105k + 15% Bonus + Equity

Location:              Malvern, PA – Presence on-site (90%+ in office ideal)

Relocation:         Yes

Team size:           3-4 RA staff total

 

Skill set:

  • BS or higher in life sciences
  • 5+ years Pharmaceutical regulatory experience
  • Pharma/BioTech, Vaccine and/or gene therapeutic regulatory knowledge
  • Strong writing skills pertaining to GMP, GLP and GCP international regulations
  • Experience for drafting, editing, and authoring regulatory documents
  • pre-IND, Type C guidance meeting, IND, BLA experience-ideal
  • Outstanding communication and writing skills
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