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About the Role
Serve as an integrated team member delivering medical writing services for clinical documents, including Clinical Trial Reports (CTRs), Trial Design Outlines/Clinical Trial Protocols (TDOs/CTPs) and amendments, Briefing Books, Investigator’s Brochures (IBs) and updates, Biomarker Reports, and submission documents. Focus on eye health and inflammation therapeutic areas, with senior-level experience preferred. Work dedicatedly, embedded in sponsor processes and workflows, participating in planning, project discussions, and training. Adopt sponsor’s systems, tools, and methodologies for seamless collaboration.
Responsibilities
- Set-up and management of clinical documents in the Electronic Document Management System (EDMS)
- Review and approval of the Statistical Analysis Plan in the EDMS
- Management of timelines, including proposal, finalization, and updating
- Preparation for and attendance of trial team meetings or submission meetings
- Preparation, conduct, and documentation of kick-off meetings
- Preparation, conduct, and documentation of Results Alignment Meetings (RAM)
- Writing of drafts including appropriate in-text tables and figures
- Provision of drafts and management of all review cycles, reaching consensus, integrating changes, and completing the Review Documentation Form
- Initiation and monitoring or conducting of Quality Control (QC) checks and completion of the Quality Control Documentation Form
- Creation and provision of the final document version
- 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
- Follow the appropriate process as per document type and according to sponsor SOPs
Requirements
- Bachelor’s degree in a scientific, clinical, regulatory, or related field required
- 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
- Ability to clearly and accurately present complex scientific and clinical information
- Strong organizational, time management, and project management skills
- 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
- 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)
- Familiarity with document templates, style guides, and structured authoring tools
Skills
- Medical writing
- Clinical document development
- Electronic Document Management System (EDMS)
- Statistical Analysis Plan review
- Timeline management
- Meeting preparation and attendance
- Kick-off meeting preparation and documentation
- Results Alignment Meetings (RAM)
- Draft writing
- In-text table and figure creation
- Review cycle management
- Quality Control (QC) checks
- Document finalization
- Publishing and pre-archive checks
- Technical checks
- Microsoft Word proficiency
- Document formatting
- eDMS experience
- Document template familiarity
- Style guide familiarity
- Structured authoring tools familiarity
Location
- Remote
Work Type
- Full-time
Experience Level
- Senior-level experience in eye health and inflammation preferred
- Approx 5 years of experience in medical writing
Education Level
- Bachelor’s degree in a scientific, clinical, regulatory, or related field
- Advanced degree (e.g., MSc, PhD, PharmD, MD) preferred
About the Company
- 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
Equal Opportunity
- 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.