Senior Medical Writing Leader for Global Regulatory Docs

Almirall; Sant Feliu de Llobregat; On-site; EUR 90,000 - 140,000; Full time

Job summary

Almirall is seeking a Senior Manager of Medical Writing to lead the development, coordination, and delivery of clinical and regulatory documents supporting R&D programs. The role ensures scientific accuracy, regulatory compliance, and alignment with global submission objectives.

You will collaborate with clinical development, regulatory affairs, biostatistics, and external vendors, drive AI/GenAI-enabled workflows, and mentor junior medical writers to maintain high-quality outputs.

Qualifications

• Advanced degree in Life Sciences (PhD, PharmD, MD, MSc or equivalent).
• 8+ years of medical writing experience in the pharmaceutical or biotech industry.
• Proven track record in authoring and managing clinical and regulatory documents for global submissions.
• Experience working with external vendors and overseeing outsourced activities.
• Fluent in English.

Responsibilities

• Lead the planning, writing, and review of clinical and regulatory documents including protocols, investigator brochures, clinical study reports, paediatric documentation, responses to HA questions, and submission dossiers.
• Ensure consistency, clarity, and scientific integrity across all documents in compliance with ICH guidelines, GCP, and global regulatory requirements.
• Work closely with cross-functional teams to gather scientific input and ensure alignment on messaging and content.
• Provide strategic input into document planning, dossier strategy, and global regulatory submission planning.
• Review and edit documents prepared internally or by external vendors to ensure scientific accuracy and adherence to standards.
• Contribute to the development and maintenance of medical writing standards, templates, guidance documents, and SOPs.
• Mentor and guide junior medical writers, fostering capability development and high-quality output.
• Evaluate and implement AI/GenAI-enabled authoring tools to enhance efficiency, consistency, and document quality.
• Establish guardrails, quality controls, and best practices for safe, compliant, and high-quality use of AI-generated content.
• Support change-management activities, internal training, and workflow integration of AI/GenAI capabilities within the medical writing team.
• Manage external medical writing vendors, including selection, contracting, oversight, and performance review.
• Ensure robust process governance, quality standards, and clear communication channels with external partners.

Skills

Cross-functional collaboration

Mentoring juniors

Strategic input

Attention to detail

Vendor management

Communication skills

Education

Advanced degree in Life Sciences (PhD, PharmD, MD, MSc or equivalent)

Tools

AI/GenAI tools

Document management systems

Authoring tools

Structured content management

Job description

Almirall is seeking a Senior Manager of Medical Writing to lead the development, coordination, and delivery of clinical and regulatory documents supporting R&D programs. The role ensures scientific accuracy, regulatory compliance, and alignment with global submission objectives.

You will collaborate with clinical development, regulatory affairs, biostatistics, and external vendors, drive AI/GenAI-enabled workflows, and mentor junior medical writers to maintain high-quality outputs.