Added
14 days ago
Type
Full time
Salary
Salary not provided

Related skills

gcp ich guidelines regulatory submissions ms word regulatory writing

📋 Description

  • Critically evaluate medical literature to identify primary sources and assess study design and bias.
  • Author and edit regulatory documents: protocols, investigator brochures, clinical study reports
  • Manage writing assignments and maintain project timelines across multiple tasks.
  • Apply regulatory writing conventions, templates, and style guides.
  • Collaborate with clients and teams to coordinate project requirements and communications.
  • Lead or support development of interpretive guides and mentoring of writers.

🎯 Requirements

  • 3+ years in pharma with 3–5 years in regulatory and clinical writing.
  • Bachelor’s/Master’s/PhD in a scientific field.
  • Lead author experience on clinical study protocols.
  • Experience with regulatory submissions and clinical study reports is desirable.
  • Strong interpretation of clinical data and scientific communication skills.
  • Proficiency in Word, Excel, PowerPoint, and document tools.

🎁 Benefits

  • Fully remote position, anywhere in Brazil.
  • Full-time employment.
  • Work on regulatory and clinical projects across sectors.
  • Exposure to complex clinical data and submission processes.
  • Collaborative environment with experienced professionals.
  • Mentorship and leadership development opportunities.
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