Pp 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 RD programs. This role ensures scientific accuracy, regulatory compliance, and alignment with strategic and global 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/Gen AI technologies and strengthened process governance with external vendors. /ph3 CORE RESPONSIBILITIES /h3h3 Clinical Regulatory document writing leadership /h3ullip 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. /p /lilip Ensure consistency, clarity, and scientific integrity across all documents in compliance with ICH guidelines, GCP, and global regulatory requirements. /p /li /ulh3 Cross‑functional collaboration writing strategic Input /h3ullip Work closely with cross‑functional teams to gather scientific input and ensure alignment on messaging and content. /p /lilip Provide strategic input into document planning, dossier strategy, and integral regulatory submission planning. /p /li /ulh3 Quality, standards team guidance /h3ullip Review and edit documents prepared internally or by external vendors to ensure scientific accuracy and adherence to standards. /p /lilip Contribute to the development and maintenance of medical writing standards, templates, guidance documents, and SOPs. /p /lilip Mentor and guide junior medical writers, fostering capability development and high‑quality output.



/p /li /ulh3 AI/Gen AI‑Enabled Medical Writing excellence /h3ullip Evaluate and implement AI/Gen AI‑enabled authoring tools to enhance efficiency, consistency, and document quality. /p /lilip Establish guardrails, quality controls, and best practices for safe, compliant, and high‑quality use of AI‑generated content. /p /lilip Support change‑management activities, internal training, and workflow integration of AI/Gen AI capabilities within the medical writing team. /p /li /ulh3 Vendor and process governance /h3ullip Manage external medical writing vendors, including selection, contracting, oversight, and performance review. /p /lilip Ensure robust process governance, quality standards, and clear communication channels with external partners. /p /li /ulh3 REQUIRED EDUCATION AND EXPERIENCE /h3ullip Advanced degree in Life Sciences (Ph D, Pharm D, MD, MSc or equivalent experience). /p /lilip Minimum 8 years of experience in medical writing within the pharmaceutical or biotech industry. /p /lilip Proven track record in authoring and managing clinical and regulatory documents for global submissions. /p /lilip Experience working with external vendors and overseeing outsourced activities. /p /lilip Fluent in English. /p /li /ulh3 PREFERRED SKILLS AND COMPETENCIES /h3ullip Strong understanding of ICH guidelines, GCP, CTD requirements, and global regulatory frameworks. /p /lilip Knowledge of AI/Gen AI tools and practical experience integrating them into document workflows is highly desirable. /p /lilip Proficiency with document management systems, authoring tools, and structured content management approaches. /p /lilip Strong communication skills and ability to work in dynamic cross‑functional environments. /p /lilip Excellent attention to detail, strategic thinking, and ability to manage multiple priorities. /p /lilip Strong influencing capacities, and vendor‑management capabilities. /p /li /ul /p #J-18808-Ljbffr

📌 Medical Writing Senior Manager (Barcelona)
🏢 Almirall
📍 Barcelona