Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
Exercises judgments within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
Exercises judgment within generally defined practices and policies in selecting methods and techniques.
Manages all clinical writing activities outlined in the Project Clinical Development Plans.
Reviews documents, offers guidance, and takes lead in mentoring writers in the preparation of regulatory and publication documents.
Organizes, conducts, and leads document production meetings and other meetings as necessary.
Projects Medical Writing budget, resource, and timeline requirements for CDP.
Responsible for timeline management, budget and managing outside vendors on regulatory document writing projects.
Responsible for developing and managing, Departmental Guidelines management system, Writing style guide and departmental templates such as, protocols, investigator’s brochures, final clinical study reports, IND sections.
Provides and manages internal and external writing activities.
Responsible for developing department infrastructure such as contributing to research, acquiring a document management system, establishing style guides, and generation of templates and processes.
Manages internal staffing and performance management, including hiring, training, coaching and performance reviews
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