Clinical Trials Redaction/Regulatory Response Specialist
Biogen
5 hours ago
Remote
United States
Clinical Research and Development
Responsibilities:
- Lead and execute redaction activities for clinical documents intended for public disclosure.
- Serve as a subject-matter expert on global redaction regulations and evolving health authority expectations.
- Manage redaction in line with EMA Policy 0070, Health Canada PRCI, EU CTR, and other global requirements; ensure timely delivery.
- 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 preparing health authority responses (e.g., FDA, EMA, PMDA, Health Canada) by coordinating document collection, background materials, cross-functional input, and compliant, timely submissions.
- Format, compile, and assemble response packages with consistency, clarity, and adherence to submission standards.
- Assist Regulatory Leads with fact-checking and improving grammar, clarity, and flow of response documents.
Required Skills/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.
- 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.
Benefits:
- Medical, dental, vision, and life insurances; fitness & wellness program (fitness reimbursement); short- and long-term disability; paid vacation and end-of-year shutdown (Dec 26–Dec 31); company paid holidays and personal days; sick time; paid maternity and parental leave; 401(k) with company match; employee stock purchase plan; tuition reimbursement (up to $10,000/year); employee resource groups participation.
Additional/Location Notes:
- Remote-based position; candidate must be located within the USA.
- Must be available to start work daily by 9AM EST.
- Lead and execute redaction activities for clinical documents intended for public disclosure.
- Serve as a subject-matter expert on global redaction regulations and evolving health authority expectations.
- Manage redaction in line with EMA Policy 0070, Health Canada PRCI, EU CTR, and other global requirements; ensure timely delivery.
- 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 preparing health authority responses (e.g., FDA, EMA, PMDA, Health Canada) by coordinating document collection, background materials, cross-functional input, and compliant, timely submissions.
- Format, compile, and assemble response packages with consistency, clarity, and adherence to submission standards.
- Assist Regulatory Leads with fact-checking and improving grammar, clarity, and flow of response documents.
Required Skills/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.
- 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.
Benefits:
- Medical, dental, vision, and life insurances; fitness & wellness program (fitness reimbursement); short- and long-term disability; paid vacation and end-of-year shutdown (Dec 26–Dec 31); company paid holidays and personal days; sick time; paid maternity and parental leave; 401(k) with company match; employee stock purchase plan; tuition reimbursement (up to $10,000/year); employee resource groups participation.
Additional/Location Notes:
- Remote-based position; candidate must be located within the USA.
- Must be available to start work daily by 9AM EST.