Senior Medical Writer
New
E
ExcelyaMedical Affairs
ColombiaPart-TimeSenior
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- At least 3 years
- Required Skills
- Project Management
Requirements
- Degree in Life Sciences.
- At least 3 years of experience in medical writing.
- Experience writing protocols, Clinical Study Reports (CSRs), and Common Technical Documents (CTDs).
- Fluent in English.
- Strong project management and coordination skills.
- Previous experience in CROs is a plus.
Responsibilities
- Write and edit complex medical writing deliverables (including informed consent forms, clinical study reports, clinical evaluation reports, CTD submissions) in accordance with SOPs and regulations.
- Coordinate cross-functional stakeholders including Clinical Operations, Biostatistics, and Regulatory Affairs to ensure timely collection and integration of clinical content.
- Ensure the accuracy, consistency, and regulatory compliance of all information, data, and references in produced documents.
- Contribute to document quality control by reviewing data accuracy, formatting, and industry guideline compliance.
- Mentor and lead less experienced medical writers on complex projects.
- Liaise with sponsors to negotiate changes and ensure alignment on project deliverables.
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