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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 ParexelParexel 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 RoleWe are seeking a Medical Writer II to join our team in Czechia, Hungary, UK, or Netherlands.As a Senior Medical Writer, you will serve as a dedicated, embedded resource supporting the development of high quality clinical and regulatory documents. This role plays an important part in advancing clinical research by ensuring the timely preparation, coordination, review, and finalization of key clinical documents, including Clinical Trial Reports (CTRs), Clinical Trial Protocols (CTPs), protocol amendments, Investigator's Brochures (IBs), biomarker reports, and submission related documentation.You will work closely with cross functional project teams, participate in planning and alignment activities, manage document timelines, coordinate review cycles, and support quality and compliance processes throughout the document lifecycle. Responsibilities include clinical document development, document management within electronic document management systems, stakeholder coordination, quality control oversight, and support for document approval and publishing activities.You will join a fast paced, growth oriented environment where your expertise contributes directly to the delivery of clinical research programs and the advancement of new therapies for patients. Working as an integrated member of the team, you will have the opportunity to deepen your knowledge of clinical development processes while helping ensure the successful execution of critical study and submission milestones.Key ResponsibilitiesDevelop and maintain clinical and regulatory documents including CTRs, CTPs, protocol amendments, IBs, biomarker reports, and submission documentsManage clinical documents within the Electronic Document Management System (EDMS), including document setup, workflow management, and approvalsEstablish, communicate, and maintain agreed project timelines in collaboration with trial and project teamsPrepare for, facilitate, and document project meetings, kick off meetings, Results Alignment Meetings, trial team meetings, and submission meetings as requiredDraft clinical documents, including appropriate in text tables and figures, in accordance with agreed timelines and applicable proceduresCoordinate and manage document review cycles, drive alignment on comments, integrate revisions, and complete required review documentationInitiate, conduct, or oversee quality control activities and complete supporting quality control documentationFinalize and deliver completed documents to project teams and support document publishing and pre archive activitiesPerform technical and formatting checks for Investigator's Brochures and related updatesSupport final electronic approval processes and ensure compliance with established procedures, systems, and standard operating proceduresCollaborate effectively within an integrated team environment and participate in ongoing project governance, feedback, and alignment activitiesCandidate ProfileYou'll thrive in this role if you bring:Strong medical writing, project coordination, and document management capabilitiesExperience working in clinical research or another regulated environmentThe ability to collaborate across teams and communicate clearly with a variety of stakeholdersA quality focused mindset and strong attention to detailComfort working with electronic document management systems, document review processes, and quality control proceduresRequired QualificationsAt least 1 year experience as Medical WriterBachelor's degree or equivalent combination of education and relevant experienceKnowledge of clinical development documentation processes and regulated working environmentsExperience working with Electronic Document Management Systems (EDMS) and document lifecycle management processesStrong communication, organization, stakeholder management, and problem solving skillsPreferred QualificationsAdvanced scientific, life sciences, or related educational backgroundExperience supporting clinical trial documentation and regulatory submissionsFamiliarity with clinical document review, quality control, publishing, and approval workflowsExperience collaborating within cross functional clinical development teams
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