- Author and manage development of clinical regulatory documents (protocols, amendments, clinical study reports, Investigator's Brochures, and IND/CTA submissions)
- Ensure regulatory, technical, and quality standards are met and apply best practices
- Balance multiple tasks across drug projects and prioritize effectively
- Maintain clarity, accuracy, format, and consistency of scientific content
- Collaborate with external service providers/contractors as needed
- Develop collaborations across Alexion functions and stay informed on regulatory and MW knowledge
- Aim for continuous improvement and represent Alexion MW in communications
- Work independently with guidance from senior team members
- Operate as an individual contributor with no direct reports
- Science-based education or experience, preferably pharmacology
- Academic foundation in science, preferably pharmacology
- Strong ability to analyze pharmacology data and summarize for submissions
- Experience in regulatory documentation and/or medical communications
- Medical writing experience in the pharmaceutical industry
- Excellent oral, written, and presentation skills
- Knowledge of regulatory requirements relevant to the role
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Senior Manager, Nonclinical and Clinical Pharmacology Writing - Barcelona - Alexion Pharmaceuticals
Descripción
Experteer Overview¿Interesado en saber más sobre este trabajo?
Desplácese hacia abajo y descubra qué habilidades, experiencia y cualificaciones académicas se necesitan.
In this role you will support theAlexion Rare Disease Unit by authoring and managing high-quality, regulatory-compliant nonclinical and clinical documents for early and late-stage programs.
You work within the Medical Writing & Clinical Trial Transparency team to enable clinical research and regulatory approvals, collaborating across functions and external partners.
The position combines independent execution with senior guidance, emphasizing accuracy, consistency, and regulatory rigor. This is a hybrid, office-based role in Barcelona, offering impact on rare-disease therapies and opportunities to shape regulatory submissions.Compensaciones / Beneficios
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Medical Writers
Solo para miembros registrados Barcelona, Catalonia
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Expert Medical Regulatory Writer
Solo para miembros registrados Barcelona, Barcelona provincia
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Principal Medical Regulatory Writer
Solo para miembros registrados Barcelona, Barcelona provincia
-
Expert Medical Regulatory Writer
Solo para miembros registrados Barcelona
-
Principal Medical Regulatory Writer
Solo para miembros registrados Barcelona
-
Clinical Biometrics Manager
Solo para miembros registrados Barcelona, Catalonia
-
Toxicologist Graduate
Solo para miembros registrados Barcelona, Catalonia
-
VP Venture investments, We Venture Capital
Solo para miembros registrados Barcelona, Catalonia
-
Medical Writers
Solo para miembros registrados Barcelona
-
Expert Medical Regulatory Writer
Solo para miembros registrados Barcelona
-
Principal Medical Regulatory Writer
Solo para miembros registrados Barcelona
-
Expert Medical Regulatory Writer
De jornada completa Solo para miembros registrados Barcelona
-
Principal Medical Regulatory Writer
De jornada completa Solo para miembros registrados Barcelona
-
Toxicologist Graduate
Solo para miembros registrados Barcelona
-
Clinical Biometrics Manager
Solo para miembros registrados Barcelona
-
Toxicologist Graduate
Solo para miembros registrados Hospitalet de Llobregat
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Toxicologist Graduate
Solo para miembros registrados Barcelona, ES,