Director, Nonclinical and Clinical Pharmacology Writing

JR Spain; Barcelona; Presencial; EUR 70.000 - 90.000; Jornada completa

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

Regulatory medical writing experience

Communication skills

Microsoft Office proficiency

Knowledge of regulatory requirements

Project management skills

Educación

PhD or MS in life sciences or relevant field

Descripción del empleo

Job Title: Director, Nonclinical and Clinical Pharmacology Writing, Barcelona

Client:

Alexion Pharmaceuticals, Inc.

Location:

Barcelona, Spain

Job Category:

Other

EU Work Permit Required:

Yes

Job Reference:

163299174470018662432460

Job Views:

1

Posted:

23.07.2025

Expiry Date:

06.09.2025

Job Description:

Location: Barcelona, Spain

Job Reference: R-211288

Date Posted: 06/23/2025

Position Overview:

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.

Key Responsibilities:

• 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.

Qualifications:

• 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.

Preferred Qualifications:

• 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.

Additional Information:

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.