[Hiring] Clinical Trials Redaction/Regulatory Response Specialist @Biogen

Role Description

This is a remote-based position, candidate must be located within the USA. Must be available to start work daily by 9AM EST.

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 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.

Qualifications

• 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.

Requirements

• Project management experience.

Benefits

• The base compensation range for this role is: $126,000.00-$176,000.00.
• Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
• Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
• 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.