ph3About Parexel /h3 pParexel 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. /p h3About Parexel /h3 pParexel 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. /p h3About The Role /h3 pWe 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. /p h3Key Responsibilities /h3 ul liDocument management within the EDMS.



/li liReview and approval of Statistical Analysis Plans in the EDMS. /li liManagement of timelines and ongoing schedule updates. /li liPreparation for and attendance at trial team and submission meetings. /li liPreparation, conduct, and documentation of kick off meetings. /li liPreparation, conduct, and documentation of Results Alignment Meetings where applicable. /li liWriting of drafts including tables and figures according to agreed timelines. /li liManagement of review cycles, comment reconciliation, and review documentation. /li liInitiation, monitoring, or conduct of Quality Control reviews and associated documentation. /li liCreation and provision of final document versions to project teams. /li liPublishing support, pre archive checks, and resolution of findings. /li liElectronic approval of final clinical documents in the EDMS. /liliTechnical and formatting checks for IBs and updates. /li liCompliance with sponsor processes and SOPs. /li liParticipation in governance, feedback, and alignment meetings. /li /ul h3Candidate Profile /h3 h3You Will Thrive In This Role If You Bring /h3 ul liPrevious Medical Writer or Senior Medical Writer experience. /li liStrong collaboration and communication skills. /li liExcellent attention to detail and document quality focus. /li liA patient focused mindset and commitment to advancing clinical research. /li /ul h3Required Qualifications /h3 ul liScientific degree and/or advanced scientific degree. /li li5 years' experience within medical writing. /li liKnowledge of ICH GCP, regulatory requirements, and clinical trial processes. /li liExperience with clinical document management systems and related tools. /li liStrong communication, organization, and problem solving skills. /li /ul pWe 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. /p /p #J-18808-Ljbffr

📌 Senior Medical Writer - Sponsor Dedicated - Italy remote (Italia)
🏢 Parexel
📍 Italia