Senior Medical Writer
JobgetherRemotely
gcpregulatory submissionsregulatory writingms wordich guidelinesclinical study protocols
Job Description
📋 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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