Clinical Trials Redaction/Regulatory Response Specialist

This is a remote-based position, candidate must be located within the USA

Must be available to start work daily by 9AM EST

About This Role

The Medical Writing Redaction/Regulatory Response Specialist leads and executes redaction activities for clinical documents intended for public disclosure, ensuring compliance with global requirements and supporting Medical Writing in delivering high-quality redacted packages. 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.

The Specialist reports to the Associate Director of Medical Writing Operations and is a is a core member of the Medical Writing Operations structure, contributing to both document delivery excellence and broader clinical submission readiness.

What You'll Do

• Serve as the subject-matter expert on global redaction regulations and evolving health authority expectations
• Manage redaction of clinical documents in line with EMA Policy 0070, Health Canada PRCI, EU CTR, and other global requirements and oversee timely delivery of redaction workflows
• Maintain and update CCI redaction trackers across programs
• Assess internal and external technology solutions to improve redaction processes
• Support audits and inspections related to redaction activities
• Support Regulatory teams in preparing health authority responses (e.g., FDA, EMA, PMDA, Health Canada) by coordinating document collection, background materials, cross-functional input, and ensuring timely, compliant submissions
• Format, compile, and assemble response packages with consistency, clarity, and adherence to submission standards
• Assist Regulatory Leads with fact-checking and enhancing grammar, clarity, and flow of response documents

• Minimum bachelor's degree, Life or Health Sciences preferred
• 7+ years of experience in redaction operations, Medical Writing Operations, and/or regulatory affairs in the pharmaceutical industry
• Strong understanding of global redaction requirements (EU CTR, Policy 0070, PRCI, etc.)
• Exceptional attention to detail and strong written communication skills
• Ability to work under tight timelines with high quality and minimal supervision
• Strong organizational, timeline management, and cross-functional collaboration abilities
• Proficient with major Microsoft suite programs
• Experience in leading regulatory meetings

• Project management experience

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation