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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
Who You Are
You are an insightful, customer-focused professional who collaborates effectively across diverse teams. You manage multiple priorities well, deliver high-quality work in dynamic environments, and bring strong organizational skills. You consistently demonstrate integrity, agility, and a positive approach in a fast-paced, compliant setting.
Required Skills
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
Preferred Skills
Project management experience
#LI-Remote
Job Level: Management
Additional Information
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.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being ; including, but not limited to:
- 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
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
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