Senior Medical Writer at Excelya

, , Poland -

Full Time

Start Date

Immediate

Expiry Date

29 Jan, 26

Salary

0.0

Posted On

31 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Medical Writing, Regulatory Documents, Literature Reviews, Quality Control, Statistical Analysis, Cross-Functional Collaboration, Mentoring, ICH Regulations, CONSORT Guidelines, STROBE Guidelines, PRISMA Guidelines, Analytical Skills, Teamwork, Creativity, Intellectual Curiosity, Strong Work Ethic

Industry

Pharmaceutical Manufacturing

Description

Why Join Us? At Excelya, we are committed to excellence in healthcare, and we invite you to be part of our dedicated team where your expertise can make a significant impact. As a young, ambitious health company with over 900 talented professionals, we strive to be Europe's leading mid-size CRO, delivering the best employee experience. Our integrated service model enables you to engage in diverse projects, working alongside industry experts to enhance scientific knowledge and improve the patient journey. About the Job We are seeking a Senior Medical Writer to produce medical writing deliverables (both regulatory and medical communication documents). Main Activities: Ensure compliance with sponsors’ and Excelya’s SOPs, guidelines, and relevant legislation. Stay updated on changes in industry standards, laws, and procedures. Conduct literature reviews aligned with project and sponsor requirements. Write, edit, and review a wide range of medical documents (protocols, CSRs, ICFs, CTDs, manuscripts, etc.). Perform quality control for accuracy, consistency, and compliance with industry standards. Review statistical analysis plans, tables, and figures for clarity and correctness. Collaborate with cross-functional teams (data management, biostatistics, project management) to ensure timely and high-quality deliverables. Communicate with sponsors to manage document expectations and negotiate changes. Mentor and support junior and senior medical writers; act as backup when needed. Contribute to project coordination and assist other Medical Affairs team members as required. About You We are looking for candidates who embody our values of Audacity, Care, and Energy: Master degree in life sciences or equivalent A relative experience of a minimum of 3 years in medical writing. Has previous experience working a CRO Analytical skills and ability to interpret data A strong work ethic Intellectual curiosity and creativity The ability to work effectively in a team in a fast-paced and dynamic environment Advanced level of English Strong knowledge of ICH regulations, and CONSORT, STROBE and PRISMA guidelines Why Join Us? At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare. Here's what makes us unique— We are a young, ambitious health company representing 900 Excelyates, driven to become Europe's leading mid-size CRO with the best employee experience. Our one-stop provider service model—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey. Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.

Responsibilities

The Senior Medical Writer will produce medical writing deliverables, ensuring compliance with relevant guidelines and legislation. They will collaborate with cross-functional teams and mentor junior writers while managing document expectations with sponsors.