Clinical Trials Redaction/regulatory Response Specialist

Biogen Support

USA
Base: $126,000.00-$176,000.00; bonus/equity: short...
Fully remote
7+ years experience in redaction operations
Strong understanding of global redaction requirements
Proficient with microsoft suite programs
Biogen Support is seeking a fully remote Clinical Trials Redaction/Regulatory Response Specialist to lead redaction activities for clinical documents and provide support for regulatory responses. The ideal candidate should have over seven years of experience in redaction operations or regulatory affairs within the pharmaceutical industry, with strong attention to detail and organizational skills

Job Summary

  • The role leads redaction activities for clinical documents to ensure compliance with global health authority expectations such as EMA Policy 0070 and EU CTR.
  • Candidates must be available to start work daily by 9AM EST and possess a minimum bachelor's degree in Life or Health Sciences.
  • Biogen offers a competitive benefits package including up to $10,000 in tuition reimbursement, paid parental leave, and equity incentive opportunities.

Matching Summary

Match Score: 85

Biogen Support is seeking a fully remote Clinical Trials Redaction/Regulatory Response Specialist to lead redaction activities for clinical documents and provide support for regulatory responses. The ideal candidate should have over seven years of experience in redaction operations or regulatory affairs within the pharmaceutical industry, with strong attention to detail and organizational skills.

Salary

Base: $126,000.00-$176,000.00; Bonus/Equity: Short term and long-term incentives including cash bonus and equity; Benefits: Medical, Dental, Vision, 401(k) match, Tuition reimbursement

Skills & Requirements

Must-have

  • 7+ years experience in redaction operations
  • Strong understanding of global redaction requirements
  • Proficient with Microsoft suite programs

Nice-to-have

  • Project management experience
  • Experience leading regulatory meetings
  • Agility in fast-paced compliant setting

Key Requirements

  • Minimum bachelor's degree in Life or Health Sciences
  • 7+ years of pharmaceutical industry experience
  • Must be located within the USA

Work Rights

Must be located within the USA

Tailored Resume

Cover Letter