Clinical Trials Redaction/regulatory Response Specialist

Biogen

Remote, USA
Base: $126,000.00-$176,000.00; bonus/equity: cash ...
Remote
Global redaction regulations
Ema policy 0070
Health authority response preparation
Biogen is seeking a Clinical Trials Redaction/Regulatory Response Specialist for a remote position in the USA. The role involves leading redaction activities for clinical documents, ensuring compliance with global regulations, and supporting regulatory responses

Job Summary

  • The Medical Writing Redaction/Regulatory Response Specialist leads and executes redaction activities for clinical documents intended for public disclosure, ensuring compliance with global requirements.
  • The role also provides essential support for regulatory responses by organizing background materials, drafting and formatting response documents, coordinating cross-functional reviews, and ensuring alignment with internal standards and health authority expectations.
  • Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being.

Matching Summary

Match Score: 85

Biogen is seeking a Clinical Trials Redaction/Regulatory Response Specialist for a remote position in the USA. The role involves leading redaction activities for clinical documents, ensuring compliance with global regulations, and supporting regulatory responses.

Salary

Base: $126,000.00-$176,000.00; Bonus/Equity: Cash bonus and equity incentive opportunities; Benefits: Medical, Dental, Vision, Life insurance, 401(k) match, etc.

Skills & Requirements

Must-have

  • Global redaction regulations
  • EMA Policy 0070
  • Health authority response preparation
  • Cross-functional review coordination
  • Microsoft suite proficiency

Nice-to-have

  • Customer-focused professional
  • Agility in fast-paced environments
  • Positive approach in compliant setting

Key Requirements

  • Bachelor's degree in Life or Health Sciences preferred
  • 7+ years of experience in redaction operations, Medical Writing Operations, and/or regulatory affairs
  • Strong understanding of global redaction requirements (EU CTR, Policy 0070, PRCI, etc.)
  • Ability to work under tight timelines with high quality and minimal supervision
  • Experience in leading regulatory meetings

Work Rights

Must be located within the USA

Tailored Resume

Cover Letter