Remote Senior Medical Writer for Regulatory Submissions

Placements24; Riverton (UT); Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Fully remote

Competitive salary

Bonus program

Health insurance

Retirement planning

Paid time off

Job summary

Placements24 seeks a Senior Medical Writer to join a global pharmaceutical leader. This fully remote role supports regulatory documentation from anywhere within the country, contributing to CSRs, IBs, and CTD modules.

You will collaborate with clinical operations, biostatistics, regulatory affairs to ensure content accuracy, alignment with ICH, FDA, EMA, and SAHPRA guidelines, and timely delivery. Applicants should have 6–8 years of regulatory writing experience, an advanced life-science degree,

Qualifications

• Advanced degree (Master's or Ph.D.) in a life science or related field.
• 6–8 years of experience as a Medical Writer in pharma/biotech focusing on regulatory docs.
• Proven ability to author complex regulatory documents for global submissions.
• Strong understanding of ICH guidelines and submission requirements.
• Excellent writing, editing, proofreading, and data interpretation skills.

Responsibilities

• Author, edit, and review CSR, IBs, protocols, and CTD modules.
• Ensure documents comply with ICH, FDA, EMA, SAHPRA guidelines.
• Collaborate with clinical ops, biostatistics, and regulatory affairs to gather content.
• Manage multiple writing projects with timelines.
• Develop and implement departmental templates, style guides, and SOPs.
• Maintain knowledge of therapeutic areas and drug development processes.
• Review documents produced by teammates or external vendors.
• Ensure consistency in messaging and terminology across documents.
• Participate in team meetings and departmental initiatives.
• Stay updated on evolving regulatory requirements and best practices.

Skills

Regulatory writing

Medical writing

Project management

ICH guidelines

Independent work

Education

Master's or Ph.D. in life sciences

Job description

Placements24 seeks a Senior Medical Writer to join a global pharmaceutical leader. This fully remote role supports regulatory documentation from anywhere within the country, contributing to CSRs, IBs, and CTD modules.

You will collaborate with clinical operations, biostatistics, regulatory affairs to ensure content accuracy, alignment with ICH, FDA, EMA, and SAHPRA guidelines, and timely delivery. Applicants should have 6–8 years of regulatory writing experience, an advanced life-science degree,