Senior Medical Writer

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Excelya

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🧬 Biotechnology

Healthcare Insurance • Pharmaceuticals • Biotechnology

Excelya is a leading global Contract Research Organization (CRO) focused on advancing healthcare through innovative solutions and expert guidance. With a presence in 28 countries, Excelya supports biotech, pharmaceutical, and medical device companies by offering full-service, functional service provider (FSP), and resourcing solutions across a broad spectrum of therapeutic areas. The company's unique business model emphasizes collaboration and flexible services, enabling clients to deliver life-changing therapies effectively.

📋 Description

• **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.

🎯 Requirements

• **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.

🏖️ Benefits

• **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.