Regulatory Document Specialist / Scientific Editor

Position Summary

This role is for a seasoned Regulatory Document Specialist / Scientific Editor who will help prepare, format, and quality-check regulatory submission materials. The work is fully remote and centered on ensuring that scientific and regulatory documents are accurate, consistent, and ready for publication or filing.

The ideal candidate will bring strong hands-on experience with EndNote and document-formatting platforms such as StartingPoint, along with a solid background in proofreading complex scientific or regulatory content.

Key Responsibilities

• Review regulatory application content to make sure the narrative flows consistently and clearly.
• Check grammar, punctuation, spelling, and overall readability across documents.
• Verify that content follows the required style standards and formatting rules.
• Use electronic publishing and formatting tools to prepare scientific and regulatory files.
• Organize, manage, and format citations and reference lists in EndNote.
• Transform scientific reference materials into a polished, submission-ready format.
• Prepare manuscripts and related documents so they meet journal submission requirements.
• Maintain consistency throughout large and complex regulatory packages.
• Work with internal stakeholders to uphold document quality and formatting standards.

Required Qualifications

• At least 5 years of experience in scientific editing, regulatory publishing, technical writing, or document formatting.
• Advanced practical knowledge of EndNote.
• Strong working experience with SharePoint.
• Background in proofreading and formatting scientific, medical, pharmaceutical, or regulatory documents.
• Excellent editing ability and a strong eye for document quality review.
• Ability to work independently in a remote setting with close attention to detail.

Preferred Qualifications

• Experience using StartingPoint or comparable tools such as GlobalSubmit.
• Prior support for regulatory submission work.
• Familiarity with ALCS style guidelines is helpful, though not mandatory.
• Exposure to scientific publishing, manuscript preparation, or journal submission workflows.

Additional Information

This is a part-time remote position with up to 20 hours per week, and the workload may rise to 30 hours per week depending on business needs. The pay rate is $35 per hour.

Preferred Industry Experience

• Pharmaceutical
• Life sciences
• Biotechnology
• Medical research
• Regulatory affairs