20 publicaciones de empleo destacadas de clinical research en alcobendas, md (¡Están contratando!)

Senior/ Medical Writer - FSP
IQVIA —Madrid, Madrid provincia
- Jornada completa
- Trabajo híbrido
- Microsoft Word
- Doctorado
- Investigación
9d
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- Jornada completa
- Grado
- Liderazgo
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- Teletrabajo opcional
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Ergomed —Madrid, Madrid provincia
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- Teletrabajo
- Inglés
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Solicitud rápida
Medical Monitor (Gastroenterology)
PSI CRO —Madrid, Madrid provincia
- Jornada completa
- Trabajo híbrido
- Inglés
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Medical Engagement Partner Cardiometabolic Diseases - Noreste y Norte
Roche —Madrid, Madrid provincia
- Jornada completa
- Inglés
- Investigación
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Trilingual Health Psychologist (Spanish, English, and Portuguese)
Lyra Health —Madrid, Madrid provincia
- De 31.000 € a 36.000 € al año
- Jornada completa
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- Español
- Inglés
- Grado
Senior Project Manager / Associate Project Management Director
Optimapharm d.o.o. —Madrid, Madrid provincia
- De 80.000 € a 100.000 € al año
- Jornada completa
- Teletrabajo
- Inglés
- Investigación
- Máster
Medical Engagement Partner Cardiometabolic Diseases - Madrid, CLM y Comunidad Valenciana
Roche —Madrid, Madrid provincia
- Jornada completa
- Inglés
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M3EU —Madrid, Madrid provincia
- Jornada completa
- Teletrabajo
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
Solicitud rápida
Business Development Manager – Medical Affairs Solutions (IQVIA Pharma Review)
IQVIA —Madrid, Madrid provincia
- Jornada completa
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SpotLab —Madrid, Madrid provincia
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Associate Medical Director- Neurology
IQVIA —Madrid, Madrid provincia
- Jornada completa
- Inglés
- Desarrollo de negocios
- Teletrabajo opcional
CRA I-II in Madrid. Sponsor dedicated.
サイネオス・ヘルス —Madrid, Madrid provincia
- Grado
10d

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Senior/ Medical Writer - FSP

IQVIA -
Madrid, Madrid provincia

Solicitar ahora

Detalles del empleo

Jornada completa
Hace 9 días

Cualificaciones

Microsoft Word
Investigación clínica
Doctorado
Investigación
Máster
Project management
Grado
Farmacia
Gestión del tiempo

Descripción completa del empleo

Madrid, Spain | Full time | Hybrid | R1560755

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.

Where you'll work

Hybrid

You’ll split your time between home and the office, giving you the flexibility to focus where you work best while still building strong in-person connections with your team. This model combines the autonomy of remote work with the collaboration, energy and resources of an office environment.

Culture

Culture at IQVIA is built on a shared belief: that when people are empowered with better data, smarter technology and deeper expertise, they can change what’s possible for patients. Across every team and every corner of the globe, you’ll find colleagues who genuinely care — about the mission and about each other. That’s what makes this a place where people tend to stay, grow and do the best work of their careers.

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Refina tu búsqueda

clinical research empleos en alcobendas, md

Senior/ Medical Writer - FSP

Medical Affairs Business Analyst - Pharma R&D

Field Service Engineer - Diagnostics & Life Science

Sr. Clinical Project Manager (Europe)

Medical Strategy Lead, Oncology-Clinical Development (Centre of Excellence)

Medical Scientist Lead

Medical Science Liaison

Medical Engagement Partner Cardiometabolic Diseases - Andalucia, Extremadura, Murcia y Canarias

Associate/ Study Start Up Manager, IQVIA Biotech

Principal Biostatistician

Medical Monitor (Gastroenterology)

Medical Engagement Partner Cardiometabolic Diseases - Noreste y Norte

Trilingual Health Psychologist (Spanish, English, and Portuguese)

Senior Project Manager / Associate Project Management Director

Medical Engagement Partner Cardiometabolic Diseases - Madrid, CLM y Comunidad Valenciana

Qualitative Project Assistant (French speaking)

Business Development Manager – Medical Affairs Solutions (IQVIA Pharma Review)

Regulatory & Quality Lead – AI IVD Diagnostics

Associate Medical Director- Neurology

CRA I-II in Madrid. Sponsor dedicated.

Quiero recibir la alerta de empleo más reciente de clinical research en alcobendas, md

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