Senior Medical Writer (Colombia) at Excelya

, , Colombia -

Full Time

Start Date

Immediate

Expiry Date

21 Sep, 26

Salary

0.0

Posted On

23 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Medical Writing, Clinical Study Reports, Clinical Evaluation Reports, CTD Submissions, Informed Consent Forms, Project Management, Stakeholder Coordination, Regulatory Compliance, Quality Control, Mentoring, English Fluency

Industry

Pharmaceutical Manufacturing

Description

Redefine Medical. Empower Innovation. Build with Audacity. Join Excelya as Our Next Medical Star! At Excelya, we don’t just work—we Excelyate. Across 24 countries, 900+ passionate professionals are shaping the future of healthcare with one bold ambition: to become Europe's leading mid-size CRO, offering the best employee experience. Now, we’re calling on curious minds and courageous spirits to step into a career-defining role in Medical Affairs. Ready to make an impact that travels the globe? Let’s talk. About the Job 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. Your Mission: 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. What You Bring to the Table: We are looking for candidates who embody our values of Audacity, Care, and Energy and also: 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. Why Choose Excelya? At Excelya, we lead with Audacity, act with Care, and move with Energy. We nurture your potential through high-impact projects, give your talents the space to shine, and push boundaries to elevate every patient’s journey. Here, you're not just doing a job—you’re becoming a key part of something bigger. So, if you're ready to excel with purpose, let’s write the next chapter together.

Responsibilities

The role involves writing and editing complex medical deliverables such as clinical study reports and CTD submissions while ensuring regulatory compliance. It also requires coordinating cross-functional stakeholders and mentoring junior medical writers to ensure high-quality scientific output.