Clinical Documentation Specialist | $70/hr Remote

Position: Regulatory Affairs Specialist Type: Contract Compensation: $50 - $70/hour Location: Remote Commitment: 10-40 hrs/week Role Responsibilities Author and review evaluation tasks inspired by real-world agency requests and sponsor response threads.Apply expert judgment to review clinical documentation for regulatory compliance.Distinguish between substantively adequate and superficially polished responses.Assess consistency across comprehensive document sets, identifying unsupported or conflicting claims.Provide structured, well-reasoned written feedback grounded in applicable regulatory guidelines.Collaborate asynchronously and communicate complex regulatory concepts clearly. Requirements Have strong relevant experience in the domain of regulatory affairs.Documented experience drafting or leading responses to health authority information requests.Demonstrated working knowledge of the ICH framework and CTD/eCTD structure.Proven ability to critically read clinical or safety documents to identify regulatory risks.Exceptional written communication skills with the capability to convey regulatory reasoning clearly.Degree in life sciences, pharmacy, medicine, or a related field; RAC certification is an advantage. Application Process Easy Apply on LinkedInCheck email for next stepsParticipate in resume evaluation & interview stage