Senior Medical Writer – Clinical & Regulatory Documents

About the role

We are seeking an experienced Senior Medical Writer to lead the development of high‑quality clinical and regulatory documents that support global submissions. The role is pivotal in ensuring scientific accuracy, consistency, and regulatory compliance across Investigator’s Brochures, Clinical Study Reports and marketing authorization applications.

Key responsibilities

• Lead the development of high‑quality clinical and regulatory documents (e.g., Investigator’s Brochures, Clinical Study Reports, clinical summaries, and marketing authorization submissions) in compliance with global regulatory guidelines (ICH, FDA, EMA) and internal standards.
• Act as the lead writer for key summary documents, overseeing medical writing activities across multiple compounds or programs.
• Provide strategic guidance to cross‑functional teams on document content, messaging, and regulatory positioning.
• Manage medical writing projects, including planning, timelines, resource coordination, and delivery to meet milestones and submission deadlines.
• Collaborate with Clinical, Regulatory Affairs, Biostatistics, Safety, and other stakeholders to gather, interpret, and accurately present clinical data.
• Mentor and support other medical writers to ensure high‑quality, scientifically sound, and consistent deliverables.
• Review and edit project‑related documents for accuracy, clarity, consistency, and compliance with templates and style guides.
• Contribute to and lead process‑improvement initiatives to enhance efficiency, quality, and consistency in document preparation.
• Develop, maintain, and refine SOPs, templates, and best practices for medical writing.

Required profile

• Bachelor’s degree in a scientific, clinical, regulatory, or related field (advanced degree such as MSc, PhD, PharmD, MD preferred).
• Minimum of 5+ years of experience in medical writing within the biopharmaceutical, biotechnology, or CRO industry (or equivalent experience in clinical or pre‑clinical development).
• Strong knowledge of global regulatory requirements and guidelines (ICH, FDA, EMA) across all phases of clinical development.
• Broad understanding of clinical research processes, including study design, data analysis, and regulatory submissions.

Required skills