Senior Medical Writer — Clinical Protocols & Regulatory Docs

SystImmune, Inc.; États-Unis; À distance; USD 85 000 - 120 000; Plein temps

Résumé du poste

SystImmune, Inc. in Redmond, WA is seeking a Medical Writer to lead and oversee regulatory clinical documentation, including protocols, CSRs, and INDs. The role emphasizes quality, regulatory compliance, and clear scientific communication across trial teams.

The successful candidate will ensure documents meet FDA and ICH guidelines, work within templates, and manage timelines while coordinating with cross-functional teams on study materials and briefing documents.

Qualifications

• Master's degree in a life sciences discipline or 3–4 years of pharmaceutical medical writing experience, or PhD with at least 1 year of pharma medical writing experience.
• Excellent writing and communication skills.
• Proven interpersonal, organizational and problem-solving abilities in a matrix management environment.
• Knowledge of FDA and ICH guidelines.
• Skilled in clinical data interpretation.
• Proven experience writing/supporting major documents (e.g., protocols, CSRs, ISE, ISS, and Clinical Overview).

Responsabilités

• Write, edit and manage the production of high-quality clinical documentation including clinical study protocols, synopses, and clinical study reports for submission to regulatory authorities in support of marketing applications and BLAs.
• Act as a member of clinical trial teams.
• Follow and track clinical documentation milestones.
• Write/edit other strategic documents, as required

Connaissances

Medical writing

Regulatory knowledge

Communication

Team collaboration

Formation

Master's degree in life sciences

PhD with pharma medical writing experience

Description du poste

SystImmune, Inc. in Redmond, WA is seeking a Medical Writer to lead and oversee regulatory clinical documentation, including protocols, CSRs, and INDs. The role emphasizes quality, regulatory compliance, and clear scientific communication across trial teams.

The successful candidate will ensure documents meet FDA and ICH guidelines, work within templates, and manage timelines while coordinating with cross-functional teams on study materials and briefing documents.