Remote Medical Writer – Clinical Development (CNS / Regulatory Writing)

Job ID: 37863940
Location: Remote – United States
Contract Duration: 4 Months
Work Schedule: Flexible, approximately 20–40 hours per week
Work Hours: Must be available for U.S. East Coast and occasional Japan-aligned meetings
Industry: Pharmaceutical / Biotechnology / Clinical Research

Job Overview

Sigma Systems is seeking an experienced Medical Writer – Clinical Development for a 4-month remote contract opportunity supporting clinical development programs within the pharmaceutical and biotechnology industry.

This is a hands-on, individual contributor position requiring strong expertise in clinical and regulatory medical writing, particularly the development of clinical study protocols, Clinical Study Reports (CSRs), Investigator Brochures (IBs), briefing books, and regulatory submission documents.

The ideal candidate will have at least 5 years of pharmaceutical or biotechnology regulatory writing experience, with recent experience in Central Nervous System (CNS) clinical development. Experience with biologics or vaccines is highly desirable.

Candidates must be comfortable independently authoring and editing complex clinical and regulatory documents while collaborating with cross-functional teams across different time zones, including the United States and Japan.

Key Responsibilities

• Author, edit, and review clinical and regulatory documents, including:
  • Clinical Study Protocols and Protocol Amendments
  • Clinical Study Reports (CSRs)
  • Investigator Brochures (IBs)
  • Regulatory Briefing Books
  • IND and NDA submission documents
  • Other clinical and regulatory summary documents
• Translate complex scientific, clinical, and statistical information into clear, accurate, and submission-ready documentation.
• Collaborate with Clinical Development, Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Pharmacovigilance, and Medical Affairs teams.
• Coordinate document review cycles, incorporate reviewer feedback, and resolve comments to ensure document accuracy and consistency.
• Manage document development timelines and negotiate deliverables with cross-functional stakeholders.
• Ensure all documents comply with applicable regulatory guidelines, ICH requirements, Good Clinical Practice (GCP), and internal quality standards.
• Support regulatory submissions, health authority interactions, and inspection readiness activities.
• Contribute to improving medical writing templates, processes, style guides, and documentation standards.

Required Qualifications

• Bachelor's degree or higher in a relevant scientific, medical, pharmacy, or life sciences discipline. Advanced degree preferred.
• Minimum of 5+ years of hands-on regulatory medical writing experience in the pharmaceutical, biotechnology, or clinical research industry.
• Demonstrated experience independently authoring clinical and regulatory documents.
• Strong experience developing clinical study protocols, CSRs, Investigator Brochures, and regulatory submission documents.
• Recent CNS (Central Nervous System) therapeutic area experience is required.
• Strong understanding of clinical development processes, regulatory requirements, and ICH guidelines.
• Excellent scientific writing, editing, and communication skills.
• Experience coordinating document review cycles and working with cross-functional clinical development teams.
• Ability to manage multiple deliverables, negotiate timelines, and work independently.

Preferred Qualifications

• Experience supporting biologics or vaccine development programs.
• Experience preparing IND/NDA submissions and regulatory briefing packages.
• Familiarity with global clinical development programs and international regulatory requirements.
• Experience working with cross-functional teams across U.S. and Japan time zones.

Work Schedule and Availability

• Remote opportunity within the United States.
• Approximately 20–40 hours per week, depending on project requirements.
• Flexible hours with availability for U.S. East Coast business hours.
• Must be available for occasional early-morning meetings (approximately 8:00 AM ET) and evening meetings (approximately 6:00–8:00 PM ET) to coordinate with Japan-based teams.
• Opportunity for increased hours and responsibilities based on project needs and performance.

Important Candidate Considerations

This position requires broad clinical regulatory writing capabilities and recent CNS therapeutic area experience.

Candidates whose experience is exclusively or predominantly oncology-focused, particularly those with several years of recent oncology-only medical writing experience, may not be suitable for this opportunity.

This is not a medical communications, scientific content, or literature review-only position. Candidates must have direct, hands-on experience authoring clinical and regulatory documents.

Why Apply?

• Fully remote contract opportunity.
• Work on clinical development and regulatory documentation.
• Collaborate with international pharmaceutical and biotechnology teams.
• Flexible part-time to full-time workload, approximately 20–40 hours per week.
• Potential to take on additional hours and responsibilities based on project requirements and performance.