Medical Writing Manager – Clinical & Regulatory
Presente su candidatura después de leer los siguientes requisitos de habilidades y cualificaciones para este puesto.
Overview
Management-level medical writing role leading the development, coordination, and delivery of clinical and regulatory documents supporting global R&D programs.
Key Responsibilities
* Lead 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 Background
* Advanced 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 Desirable
* Hands-on exposure to AI in regulated document workflows.
* Strong strategic mindset, attention to detail, and ability to influence cross-functional teams. xohynlm
* Experience with document management systems and structured authoring approaches.
If you're interested in learning more, feel free to reach out or apply below: