The Director of Regulatory Writing leads the planning and authoring of high-quality regulatory submission components from preclinical through registration phases. They also manage external writing resources and collaborate with cross-functional teams to ensure compliance with regulatory standards.
The lead will manage clinical trial start-up activities, including regulatory submissions, site selection, and site activation. They will also oversee CRO and vendor performance to ensure project milestones are met in compliance with GCP and company policies.
The lead consultant will oversee statistical strategy for drug programs, including protocol design, SAP development, and regulatory documentation. They are also responsible for managing external CRO activities and ensuring the quality of biostatistics deliverables.
