The Medical Writing Senior Manager is responsible for leading the development, coordination, and delivery of high‑quality clinical and regulatory documents that support Almirall’s R&D; programs. This role ensures scientific accuracy, regulatory compliance, and alignment with strategic and integral submission objectives across therapeutic areas. The position collaborates cross‑functionally with clinical development, regulatory affairs, patient safety, biostatistics, and external partners to ensure timely, efficient, and effective communication of scientific data. The role also drives innovation through the informed use of AI/GenAI technologies and strengthened process governance with external vendors.

CORE RESPONSIBILITIES
Clinical & Regulatory document writing leadership
- 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.

Cross‑functional collaboration & writing strategic Input
- 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.

Quality, standards & team guidance
- 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.

AI/GenAI‑Enabled Medical Writing excellence
- Evaluate and implement AI/GenAI‑enabled authoring tools to enhance efficiency, consistency, and document quality.
- Establis

📌 Medical Writing Senior Manager (San Feliú de Llobregat)
🏢 Almirall
📍 San Feliú de Llobregat