Senior Medical Writer

This is a fully remote position, open to applicants in Colombia.

📋 Description

• **Your Mission:**

• - To compose and refine intricate medical writing deliverables (such as informed consent forms, clinical study reports, clinical evaluation reports, CTD submissions) in alignment with sponsors’ and Excelya’s SOPs, guidelines, and relevant regulations.

• - To facilitate collaboration among cross-functional stakeholders and departments (including Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, PV) to guarantee the prompt collection, review, alignment, and integration of scientific and clinical content essential for the creation of high-quality medical writing deliverables (including clinical study protocols, IBs, INDs).

• - To verify the accuracy, consistency, and regulatory compliance of all information, data, and references included in the produced publications/documents, upholding elevated standards of scientific quality.

• - To contribute to document quality assurance (reviewing data accuracy, formatting, language appropriateness, and adherence to industry guidelines).

• - To mentor and guide less experienced Medical Writers on complex projects, and to assist the Principal Medical Writer in coordinating efforts with other Medical Writers or Senior Medical Writers.

• - To communicate with sponsors to negotiate necessary modifications and ensure alignment on deliverables and expectations.

⛳️ Requirements

• **What You Bring to the Table:**

• We seek candidates who embody our values of Audacity, Care, and Energy, as well as:

• - A degree in Life Sciences.

• - A minimum of 3 years of experience in medical writing.

• - Experience in writing protocols, CSRs, and CTDs.

• - Proficiency in English.

• - Previous experience in CROs is an advantage.

• - Strong project management and coordination skills.

🏝️ Benefits

• **Why Choose Excelya?**

• At Excelya, we lead with **Audacity**, act with **Care**, and move with **Energy**. We cultivate your potential through impactful projects, provide your talents the opportunity to flourish, and push boundaries to enhance every patient’s journey. Here, you're not just doing a job—you’re becoming a vital part of **something bigger**.

• So, if you're ready to **excel with purpose**, let’s write the next chapter together.