Senior Medical Writer (Oncology)

TL;DR

Senior Medical Writer (Oncology): Authoring and editing high-quality clinical, safety, and regulatory documents across all phases of clinical research with an accent on regulatory submission standards and complex medical deliverables. Focus on managing client expectations, collaborating with SMEs, and ensuring strict adherence to FDA and ICH guidelines.

Location: United States (Remote or Hybrid based on proximity to office)

Company

hirify.global is a professional services firm providing regulatory sciences, clinical research, and quality & compliance solutions for biotech and pharmaceutical organizations.

What you will do

• Author high-quality medical deliverables including protocols, study reports, IBs, and complex submission documents such as NDA, BLA, and MAA.
• Supervise and mentor junior medical writers to ensure quality and consistency.
• Manage client expectations and lead project kickoff and comment review meetings.
• Collaborate with subject matter experts in clinical operations, data management, and biostatistics.
• Coordinate QC reviews and maintain audit trails for all documents.
• Ensure strict adherence to ICH E3/E6(R2), EU MDR/IVDR, and company standard operating procedures.

Requirements

• Minimum 5 years of experience writing clinical or regulatory documents for drugs, biologics, or medical devices.
• Must be based in the United States.
• Advanced knowledge of FDA regulations, ICH guidelines, and regulatory submission processes.
• Bachelor’s degree or higher, preferably in a medical or scientific discipline.
• Expert proficiency in MS Word and familiarity with American Medical Association (AMA) style.
• Exceptional project management and communication skills.

Culture & Benefits

• Strong commitment to diversity, equity, and inclusion.
• Flexible work arrangements supporting remote work and hybrid collaboration.
• Entrepreneurial and innovative work environment.
• Transparent hiring process with personal application reviews and no AI screening tools.