Clinical Trials Redaction, Regulatory Response Specialist

Biogen

Medical Writing Specialist leading redaction activities for compliance with global requirements. Supporting regulatory responses and ensuring high-quality redacted document delivery.

Posted 4/30/2026full-timeRemote • 🇺🇸 United StatesSeniorLead💰 $126,000 - $176,000 per yearWebsite

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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

Benefits

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

redaction operationsMedical Writing Operationsregulatory affairsglobal redaction requirementsdocument formattingfact-checkingsubmission standards

Soft Skills

attention to detailwritten communicationorganizational skillstimeline managementcross-functional collaborationability to work under tight timelinesminimal supervision

Certifications

bachelor’s degreeLife SciencesHealth Sciences