Senior Medical Writer
Primary Location: India, Remote ID de la oferta R0000043704 Categoría Medical Writing Fecha de publicación 07/16/2026Overview
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
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Job Summary
We are looking for an experienced Senior Medical Writer to author, review, and manage clinical and regulatory documents supporting global drug development programs. The ideal candidate will have expertise in clinical research documentation, regulatory writing, project leadership, and stakeholder management, ensuring the delivery of high-quality documents that meet regulatory and client requirements.
Key Responsibilities
Author and review clinical and regulatory documents, including Study Protocols, Clinical Study Reports (CSRs), Investigator Brochures (IBs), Informed Consent Forms (ICFs), Clinical Overviews, Clinical Summaries, and Safety Reports.
Conduct literature reviews and analyze scientific and clinical data to support document development.
Ensure documents comply with ICH-GCP, FDA, EMA, client requirements, SOPs, and regulatory guidelines.
Coordinate cross-functional reviews, manage document timelines, and incorporate stakeholder feedback.
Serve as the Medical Writing representative on project teams and act as a primary point of contact for assigned projects.
Review statistical outputs and ensure accurate presentation and interpretation of clinical data.
Perform quality reviews to ensure data consistency, accuracy, and publishing readiness.
Mentor junior writers and contribute to process improvement, training, and SOP development initiatives.
Required Qualifications
Bachelor's, Master's, PharmD, MD, PhD, or equivalent degree in Life Sciences, Pharmacy, Medicine, or a related field.
Must have experience in Medical Writing, preferably within a CRO, pharmaceutical, or biotechnology environment.
Strong experience authoring clinical and regulatory documents such as Protocols, CSRs, Investigator Brochures, and CTD documents.
Solid understanding of clinical research, drug development processes, and ICH-GCP guidelines.
Excellent scientific writing, editing, and communication skills.
Proficiency in Microsoft Word, Excel, document management systems, and collaborative authoring tools.
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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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POR QUÉ TRABAJAR EN PAREXEL
