Clinical Trials Redaction/regulatory Response Specialist

Biogen

Remote
Base: $126,000.00-$176,000.00; bonus/equity: cash ...
Remote
Global redaction regulations
Ema policy 0070
Health canada prci
Biogen is seeking a Clinical Trials Redaction/Regulatory Response Specialist for a remote position in the USA. The role involves managing redaction activities for clinical documents and supporting regulatory responses, requiring strong expertise in global redaction regulations and excellent organizational skills

Job Summary

  • The 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, and coordinating cross-functional reviews.
  • Biogen offers a full and highly competitive range of benefits designed to support 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 managing redaction activities for clinical documents and supporting regulatory responses, requiring strong expertise in global redaction regulations and excellent organizational skills.

Salary

Base: $126,000.00-$176,000.00; Bonus/Equity: Cash bonus and equity incentive opportunities; Benefits: Medical, Dental, Vision, Life insurances, Fitness & Wellness programs, Disability insurance, Paid vacation, Holidays, Paid days off for Personal Significance, Sick time, Paid Maternity and Parental Leave, 401(k) program, Employee stock purchase plan, Tuition reimbursement

Skills & Requirements

Must-have

  • Global redaction regulations
  • EMA Policy 0070
  • Health Canada PRCI
  • EU CTR
  • Cross-functional reviews
  • Microsoft suite proficiency

Nice-to-have

  • Customer-focused professional
  • Agility and positive approach
  • Project management experience

Key Requirements

  • 7+ years of experience
  • Bachelor's degree in Life or Health Sciences preferred
  • Strong understanding of global redaction requirements
  • Ability to work under tight timelines with high quality and minimal supervision
  • Experience in leading regulatory meetings

Work Rights

Not specified

Tailored Resume

Cover Letter