Senior Medical Writer - Sponsor Dedicated - Italy remote

Job description

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. About Parexel Parexel is a leading global clinical development partner delivering insights driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient focused clinical trials that broaden access and make research a care option for anyone, anywhere. We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart®. About the Role We are seeking an experienced Medical Writer to join a key functional service provider program supporting one of our key sponsors. As a Medical Writer, you will act as an integrated resource within the team, delivering Medical Writing Services for the creation of clinical documents including CTRs, CTPs and amendments, IBs and updates, biomarker reports, and submission documents. Working in a dedicated sponsor aligned environment, you will contribute to high-quality clinical development programs through close collaboration, scientific communication, and proactive project engagement. Key Responsibilities Document management within the EDMS. Review and approval of Statistical Analysis Plans in the EDMS. Management of timelines and ongoing schedule updates. Preparation for and attendance at trial team and submission meetings. Preparation, conduct, and documentation of kick off meetings. Preparation, conduct, and documentation of Results Alignment Meetings where applicable. Writing of drafts including tables and figures according to agreed timelines. Management of review cycles, comment reconciliation, and review documentation. Initiation, monitoring, or conduct of Quality Control reviews and associated documentation. Creation and provision of final document versions to project teams. Publishing support, pre archive checks, and resolution of findings. Electronic approval of final clinical documents in the EDMS. Technical and formatting checks for IBs and updates. Compliance with sponsor processes and SOPs. Participation in governance, feedback, and alignment meetings. Candidate Profile You will thrive in this role if you bring: Previous Medical Writer or Senior Medical Writer experience. Strong collaboration and communication skills. Excellent attention to detail and document quality focus. A patient focused mindset and commitment to advancing clinical research. Required Qualifications Scientific degree and/or advanced scientific degree. 5 years’ experience within medical writing. Knowledge of ICH GCP, regulatory requirements, and clinical trial processes. Experience with clinical document management systems and related tools. Strong communication, organization, and problem solving skills. If this job does not sound like the next step in your career, but perhaps you know someone who would be a perfect fit, send them the link to apply. We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.