Medical Writer

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Author, edit, and review clinical and regulatory documents, which include Clinical Study Protocols and Protocol Amendments, Clinical Study Reports, Investigator Brochures, Regulatory Briefing Books, IND and NDA submission documents, and other clinical and regulatory summary documents.

• Convert intricate scientific, clinical, and statistical information into clear, precise, and submission-ready documentation.

• Work in conjunction with Clinical Development, Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Pharmacovigilance, and Medical Affairs teams.

• Organize document review cycles, integrate reviewer feedback, and address comments.

• Oversee document development timelines and negotiate deliverables with cross-functional stakeholders.

• Ensure that documents adhere to relevant regulatory guidelines, ICH requirements, Good Clinical Practice, and internal quality standards.

• Assist with regulatory submissions, interactions with health authorities, and activities related to inspection readiness.

• Play a role in enhancing medical writing templates, processes, style guides, and documentation standards.

⛳️ Requirements

• A Bachelor's degree or higher in a relevant scientific, medical, pharmacy, or life sciences discipline.

• At least 5+ years of practical regulatory medical writing experience within the pharmaceutical, biotechnology, or clinical research sector.

• Recent experience in the CNS (Central Nervous System) therapeutic area is mandatory.

• Proven experience in independently authoring clinical and regulatory documents.

• Strong background in developing clinical study protocols, CSRs, Investigator Brochures, and regulatory submission documents.

• Comprehensive understanding of clinical development processes, regulatory requirements, and ICH guidelines.

• Exceptional scientific writing, editing, and communication skills.

• Experience in coordinating document review cycles and collaborating with cross-functional clinical development teams.

• Capability to manage multiple deliverables, negotiate timelines, and work autonomously.

• Availability during U.S. East Coast business hours.

• Willingness to attend occasional early-morning meetings (around 8:00 AM ET) and evening meetings (approximately 6:00–8:00 PM ET) to coordinate with teams based in Japan.

• Experience supporting biologics or vaccine development programs is highly desirable.

• Familiarity with preparing IND/NDA submissions and regulatory briefing packages.

• Awareness of global clinical development programs and international regulatory requirements.

• Experience collaborating with cross-functional teams across U.S. and Japan time zones.

• Candidates must possess direct, hands-on experience in authoring clinical and regulatory documents.

• Candidates whose expertise is primarily or exclusively oncology-focused, especially those with extensive recent oncology-only medical writing experience, may not be considered suitable.

🏝️ Benefits

• Fully remote contract opportunity.

• Flexible hours.

• Adaptable part-time to full-time workload, approximately 20–40 hours per week.

• Potential for increased hours and responsibilities based on project needs and performance.

• Opportunity to assume additional hours and responsibilities based on project requirements and performance.

• Collaboration with international pharmaceutical and biotechnology teams.