Expertly delivering clinical trials operations, with care.
Senior Medical Writer
Location
Colombia
Posted
4 days ago
Salary
0
Seniority
Senior
No structured requirement data.
Job Description
Senior Medical Writer
Excelya
Role Description We are seeking a Freelancer Senior Medical Writer, based in Colombia for a part-time role, to provide medical and scientific expertise required for the successful completion of Excelya’s projects. - To write and edit complex medical writing deliverables (including informed consent forms, clinical study reports, clinical evaluation reports, CTD submissions) in accordance with sponsors’ and Excelya’s SOPs, guidelines and applicable legislation. - To coordinate cross-functional stakeholders and departments (including Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, PV) to ensure the timely collection, review, alignment, and integration of scientific and clinical content required for the development of high-quality medical writing deliverables (including clinical study protocols, IBs, INDs). - To ensure the accuracy, consistency and regulatory compliance of all information, data and references included in the produced publications/documents, maintaining high standards of scientific quality. - To contribute to document quality control (reviewing data accuracy, formatting, appropriateness of language and compliance with industry guidelines). - To mentor and lead less experienced Medical Writers on complex projects, and to support the Principal Medical Writer with the coordination of other Medical Writers or Senior Medical Writers. - To liaise with sponsors to negotiate changes where necessary and ensure alignment on deliverables and expectations. Qualifications - Degree in Life Sciences. - At least 3 years of experience in medical writing. - Experience with writing of protocols, CSRs and CTDs. - Fluent in English. - Previous experience in CROs is a plus. - Project management and coordination skills. Benefits - High-impact projects. - Opportunities to nurture your potential. - Space to shine and push boundaries.
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