Descripción de la oferta
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 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/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. 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. Vendor and process governance 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. REQUIRED EDUCATION AND EXPERIENCE Advanced degree in Life Sciences (PhD, PharmD, MD, MSc or equivalent experience). Minimum 8 years of experience in medical writing within 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. PREFERRED SKILLS AND COMPETENCIES Strong understanding of ICH guidelines, GCP, CTD requirements, and global regulatory frameworks. Knowledge of AI/GenAI tools and practical experience integrating them into document workflows is highly desirable. Proficiency with document management systems, authoring tools, and structured content management approaches. Strong communication skills and ability to work in dynamic cross‑functional environments. Excellent attention to detail, strategic thinking, and ability to manage multiple priorities. Strong influencing capacities, and vendor‑management capabilities. #J-18808-Ljbffr
