Clinical Trials Redaction/Regulatory Response Specialist
About The Position
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.
Requirements
- 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
Nice To Haves
- Project management experience
Responsibilities
- 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
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
1,001-5,000 employees
