Descripción de la oferta
The FTE Medical Writer will serve as an integrated member of the team, delivering medical writing services for the development of clinical documents, including Clinical Trial Reports (CTRs), Trial Design Outlines/Clinical Trial Protocols (TDOs/CTPs) and CTP amendments, Briefing Books, Investigator’s Brochures (IBs) and IB updates, Biomarker Reports, and submission documents such as the Summary of Clinical Efficacy and Safety, etc. Emphasis will be placed on the therapeutic areas of eye health and inflammation; senior-level experience in these areas is preferred.
The FTE Medical Writer will work on a dedicated basis and be embedded in sponsor’s processes and workflows, including Feedback and Alignment Meetings. In this role, the FTE Medical Writer will participate in ongoing project-related activities, such as planning, project discussions, and all required training sessions. The FTE Medical Writer will adopt sponsor’s systems, tools, and methodologies to ensure seamless collaboration and alignment with internal teams.
Tasks typically include, but are not limited to:
Document management: Set-up and management of clinical document in the Electronic Document Management System (EDMS)
Review and approval of the Statistical Analysis Plan in the EDMS
Management of timelines including proposal of timelines to trial/project team (based on timelines communicated by sponsor), finalising them after agreement, and updating them as appropriate
Preparation for and attendance of the required trial team meetings or submission meetings
Preparation, conduct, and documentation of kick-off meetings, e.g. for TDO/CTP, IB or CTR writing
Preparation, conduct, and documentation of Results Alignment Meetings (RAM; not applicable for Phase I in healthy volunteer studies)
Writing of drafts including appropriate in-text tables and figures according to the timelines agreed upon with trial/project team
Provision of drafts and management of all review cycles by the trial/project team, reaching consensus on comments/changes, integration of changes into the text, and completion of the Review Documentation Form (as applicable)
Initiation and monitoring or conducting of Quality Control (QC) checks as well as completion of the Quality Control Documentation Form (QCDF)
Creation and provision of the final document version to the trial/project team
Initiation of publishing and pre-archive checks, monitoring and resolution of findings
E-approval of final clinical document in the EDMS
Technical checks after the final draft of initial IBs and IB updates in the EDMS, and by going through a Final Formatting checklist document
FTE Medical Writer will follow the appropriate process as per document type and according to sponsor SOPs
Qualifications
Bachelor’s degree in a scientific, clinical, regulatory, or related field required; advanced degree (e.g., MSc, PhD, PharmD, MD) preferred
Approx 5 years of experience in medical writing within the biopharmaceutical, biotechnology, or CRO industry; equivalent experience in clinical or preclinical development will also be considered
Strong knowledge of global regulatory requirements and guidelines (e.g., ICH, FDA, EMA) across all phases of clinical development
Broad understanding of clinical research processes, including study design, data analysis, and regulatory submission requirements
Demonstrated ability to lead writing activities for complex documents and provide strategic input to cross-functional teams
Excellent written and verbal communication skills, with the ability to clearly and accurately present complex scientific and clinical information
Strong organizational, time management, and project management skills, with the ability to manage multiple priorities and meet tight deadlines
Proven ability to work collaboratively in a cross-functional, team-oriented environment while also operating independently when needed
High attention to detail with a commitment to quality, consistency, and scientific accuracy
Proficiency in Microsoft Word and document formatting best practices
Experience with electronic document management systems (eDMS) and familiarity with document templates, style guides, and structured authoring tools
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
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