Senior Medical Writer - Sponsor Dedicated - Italy remote
Primary Location: Italy, Remote ID de la oferta R0000044125 Categoría Medical Writing Fecha de publicación 07/30/2026
Overview
Como Redactor Médico en Parexel, sus sólidos conocimientos científicos, aptitudes para escribir y enfoque en el paciente comunican datos científicos complejos con eficacia a diversos interesados, incluidos organismos regulatorios, profesionales médicos y el público en general. Debe ser capaz de colaborar con equipos multidisciplinarios para desarrollar una amplia gama de documentos de investigación clínica, como formulario de consentimiento informado, reporte de estudio clínico, documentos de farmacovigilancia y más.
Fomentamos una cultura de inclusión, colaboración y aprendizaje continuo que empodera a nuestros empleados a ejercer un impacto positivo en las vidas de las personas.
Perfil del éxito
¿Posee estas competencias sociales y rasgos interpersonales para tener éxito en Parexel?
- Comunicador
- Adaptable
- Consistente
- Perspicaz
- Orientado al detalle
- Orientado al trabajo con plazos
Acerca de este rol
About Parexel
Parexel 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 Role
We 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.
Key Responsibilities
- Document management within the EDMS.
- Review and approval of Statistical Analysis Plans in the EDMS.
- Management of timelines and ongoing schedule updates.
- Preparation for and attendance at trial team and submission meetings.
- Preparation, conduct, and documentation of kick off meetings.
- Preparation, conduct, and documentation of Results Alignment Meetings where applicable.
- Writing of drafts including tables and figures according to agreed timelines.
- Management of review cycles, comment reconciliation, and review documentation.
- Initiation, monitoring, or conduct of Quality Control reviews and associated documentation.
- Creation and provision of final document versions to project teams.
- Publishing support, pre archive checks, and resolution of findings.
- Electronic approval of final clinical documents in the EDMS.
- Technical and formatting checks for IBs and updates.
- Compliance with sponsor processes and SOPs.
- Participation in governance, feedback, and alignment meetings.
Candidate Profile
You will thrive in this role if you bring:
- Previous Medical Writer or Senior Medical Writer experience.
- Strong collaboration and communication skills.
- Excellent attention to detail and document quality focus.
- A patient focused mindset and commitment to advancing clinical research.
Required Qualifications
- Scientific degree and/or advanced scientific degree.
- 5 years’ experience within medical writing.
- Knowledge of ICH GCP, regulatory requirements, and clinical trial processes.
- Experience with clinical document management systems and related tools.
- Strong communication, organization, and problem solving skills.
If this job does not sound like the next step in your career, but perhaps you know someone who would be a perfect fit, send them the link to apply.
We 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.
#LI-REMOTE
POTENCIAL TRAYECTORIA PROFESIONAL
Parexel ofrece trayectorias profesionales para que los redactores médicos progresen en su puesto técnico o gerencial, además de opciones para transferirse a otras áreas del negocio.
- Redactor Médico Adjunto
- Redactor Médico I
- Redactor Médico II
- Redactor Médico Sénior
- Experto en la MateriaGestión de personal
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