Specialist, Medical Writing
Core
Prepare high-quality and accurate New Drug Application (NDA) related documents (CSR, CTD, etc.) in accordance with regulatory requirements as a sub-writer.
Role type
Specialist, Medical Writing (Sub-writer)
Builds
NDA-related regulatory documents for pharmaceutical development
Domain
Pharmaceutical / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical writing, clinical development, regulatory affairs, post-marketing surveillance, document quality control, vendor management liaison, procedure development
Preferred skills
Medical writing training certification, strategy formulation, stakeholder relationship building
Technologies
None stated
Responsibilities
Prepare NDA-related documents and arrange their quality control, Cooperate with lead-writer in formulation of strategies (policy, schedule, budget), Participate in decision making of the assigned JDT, Prepare appropriate procedures for development and maintenance of NDA-related documents, Conduct liaison activities with the vendor regarding preparation of NDA-related documents
Seniority
Mid-level Specialist