puestos de Office en España
Director, Nonclinical and Clinical Pharmacology Writing
Descripción de la vacante
A reputable company is seeking a Director for Nonclinical and Clinical Pharmacology Writing in Barcelona. This role will be responsible for overseeing the creation of regulatory documents, managing a team, and ensuring compliance with regulatory standards. Ideal candidates will have over 10 years of experience in medical writing, excellent communication, and project management skills, and preferably a PhD or MS in life sciences.
Formación
- Minimum 10 years of regulatory medical writing experience.
- Ability to summarize complex data and produce regulatory documents.
- Thorough knowledge of global regulatory requirements and ICH/GCP guidelines.
Responsabilidades
- Develop and implement document strategies for NCCP regulatory documents.
- Mentor medical writing team members to ensure quality and efficiency.
- Manage high-quality NCCP medical writing, ensuring scientific accuracy and clarity.
Conocimientos
Educación
Job Title: Director, Nonclinical and Clinical Pharmacology Writing, Barcelona
Alexion Pharmaceuticals, Inc.
Barcelona, Spain
Other
Yes
163299174470018662432460
1
23.07.2025
06.09.2025
Location: Barcelona, Spain
Job Reference: R-211288
Date Posted: 06/23/2025
This position is responsible for the timely delivery of high-quality nonclinical and clinical pharmacology (NCCP) regulatory documents supporting the clinical development portfolio at Alexion. The role involves leading NCCP writing activities across disease areas or clinical development programs with limited supervision.
- Develop and implement document strategies for NCCP regulatory documents, including protocols, Investigator’s Brochures, and module 2 summaries for IND/CTA/NDA submissions.
- Contribute to briefing packages, responses to health authority inquiries, and other submission documents.
- Author and manage high-quality NCCP medical writing, ensuring scientific accuracy, clarity, and regulatory compliance.
- Review documents prepared by others to ensure quality and adherence to standards.
- Mentor medical writing team members to ensure quality and efficiency.
- Maintain adherence to SOPs and regulatory requirements in collaboration with cross-functional teams.
- Minimum 10 years of regulatory medical writing experience with global submissions.
- Ability to summarize complex data and produce regulatory documents.
- Excellent communication, presentation, and Microsoft Office skills.
- Thorough knowledge of global regulatory requirements and ICH/GCP guidelines.
- Experience managing internal and external medical writers and training staff.
- Strong ethical standards and professionalism.
- PhD or MS in life sciences or relevant field.
- Experience with global clinical studies, regulatory submissions, and rare diseases.
- Skills in project management, planning, and negotiation.
- Ability to adapt and innovate in changing environments.
This role is primarily office-based. Candidates must be able to use a computer, communicate via phone and electronic messaging, and collaborate effectively during standard business hours.
* El índice de referencia salarialse calcula en base a los salarios que ofrecen los líderes de mercado en los correspondientes sectores. Su función es guiar a los miembros Prémium a la hora de evaluar las distintas ofertas disponibles y de negociar el sueldo. El índice de referencia no es el salario indicado directamente por la empresa en particular, que podría ser muy superior o inferior.