Medical Writing Manager – Clinical & RegulatoryOverviewManagement-level medical writing role leading the development, coordination, and delivery of clinical and regulatory documents supporting integral R&D; programs.Key ResponsibilitiesLead planning, authoring, and review of key clinical & regulatory documents (e.G. protocols, IBs, CSRs, paediatric plans, HA responses, submission dossiers).
Ensure scientific accuracy, consistency, and compliance with ICH, GCP, and global regulatory standards.Provide strategic input into document planning, submission strategy, and global regulatory timelines.Partner cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, Safety, and external stakeholders.Review and quality-check internally and externally authored documents.Develop and maintain writing standards, templates, and SOPs.Mentor and guide medical writers to ensure high-quality output.Drive innovation through the implementation of AI medical writing tools, including governance and quality controls.Manage external medical writing vendors, ensuring performance, quality, and process compliance.Required BackgroundAdvanced degree in Life Sciences (PhD, PharmD, MD, MSc, or equivalent).8+ years' experience in medical writing within pharma or biotech.Proven experience supporting global regulatory submissions.Strong knowledge of ICH, GCP, CTD, and international regulatory frameworks.Experience managing external vendors and outsourced activities.Fluent English.Highly DesirableHands-on exposure to AI in regulated document workflows.Strong strategic mindset, attention to detail, and ability to influence cross-functional teams.Experience with document management systems and structured authoring approaches.If you're interested in learning more, feel free to reach out or apply below:*************************