[Hiring] Medical Writer @Sigma Systems, Inc.

Role Description

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 and Protocol Amendments
• Clinical Study Reports (CSRs)
• Investigator Brochures (IBs)
• Regulatory Briefing Books
• IND and NDA submission documents
• Other clinical and regulatory summary 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. 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.

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.

Requirements

• 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.

Benefits

• 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.