The Associate Director manages the overall operations of a team or major project and implements this through effective leadership. The Associate Director provides guidance and leadership for document development for regulatory filings and coordinates the clinical sections of more complex regulatory submissions, including organization, content, and resource requirements. The Associate Director applies advanced technical expertise and develops solutions to complex problems, fosters interdisciplinary understanding, and integrates Medical Writing department activities with those of other departments.
- Collaborate with key stakeholders to ensure understanding of program strategy and the nature of medical writing services required to deliver on program objective
- Proactively anticipate risks, solve complex problems, and seek out and implement process improvements
- Independently prepare clinical regulatory documents, including protocols, study reports, investigator's brochures, and sections of regulatory submission
- Provide medical writing input for study designs and statistical analysis plans
- Thoroughly analyze and critically interpret data to determine the best approach to composing each document
- Provide expert-level input to cross-functional teams that work on standard operating procedures, process improvements, and integration of new tools and technologies
- Identify new technologies and initiatives related to the preparation of clinical documents, provide well‑informed recommendations, and facilitate integration into department processes
- Superior written and verbal communication skills
- Experience writing clinical regulatory documents
- Ability to analyze, interpret, and summarize moderately complex data
- Broad understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology.
- Advanced computer skills related to word processing, templates, table/figure creation, literature searches, electronic review systems, and document management systems; can act as a resource for others for these tools.
- PhD (or equivalent degree) and strong relevant work experience.
- Ph.D and strong relevant work experience working within Biotech and Orphan Drugs arena
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