Key Responsibilities The Director, Medical Writing will lead document strategy, overseeing authoring, review processes, and writing assigned documents. They will coordinate internal and external writers, establish best practices for high-quality preclinical summaries, clinical, and regulatory submission documents, ensuring compliance with ICH/GCP/regulatory guidelines for global health authority submissions such as IND/CTA/BLA. Lead planning, authoring, and review of regulatory documents (e.g., Protocols, CSRs, IBs, briefing documents). Evaluate and review documents generated by internal and external writers for consistency, formatting, and scientific accuracy. Engage with external stakeholders including vendors and thought leaders as needed. Manage timelines for document development and approvals. Assess medical writing needs and ensure resources are adequate for timely completion. Oversee document management from draft to final version, including review coordination and style adherence. Support development and improvement of best practices, SOPs, and templates. Lead matrix teams effectively. Maintain a track record of developing high-quality scientific and regulatory documents such as protocols, study reports, and responses to regulatory questions. Deep knowledge of drug/biologic development and GxP principles. Strong leadership, planning, and project management skills . Collaborate effectively to resolve comments and meet deliverables. Manage multiple projects in a fast-paced environment, adaptable to changing priorities. Excellent communication skills and attention to detail. Self-motivated with the ability to work independently. Proficiency in Microsoft Office and electronic document management systems. Experience responding to audits. Educational background : Bachelor’s in a scientific discipline; advanced degrees preferred. Experience : 8-12 years (Bachelor's level) or 6-8 years (advanced degree) in medical/scientific writing within pharma/biotech.
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