Senior Research Analyst - Medical Writing
Job Responsibilities:
- Individual Contributor Role, however possess an established ability to work independently or as part of the team
- Write regulatory-based documents (protocols, clinical study reports including patient narratives, annual safety reports, periodic safety update reports, integrated safety and efficacy reports, clinical trial registry summaries, and submission documents) for submission to regulatory agencies and medical institutions
- Write clinical documents associated with submissions to regulatory authorities including but not limited to: model informed consents, interim and final clinical study reports, and safety update reports
- Ensure document content and style adheres to FDA/EMA/world-wide regulatory agencies or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and style guidelines.
- Conduct quantitative and qualitative analyses on findings and present and interpret results in a structured, conclusion-oriented manner, to address key project objectives
- Perform literature searches/reviews as necessary to obtain background information and training for development of documents.
- Review statistical analysis plans and mock statistical output to assist in determining appropriateness of content/format for clinical writing
- Initiate and manage development of formats, templates and general guidelines for clinical documentation and workflow procedures. Assist in the development of departmental SOPs.
- Assist management as needed with preparation of resourcing estimates for potential new medical writing projects.
- Initiate and participate in departmental or interdepartmental process improvement and training initiatives
- Keep abreast of professional information and technology through workshops and conferences, and ensure the appropriate transfer of that information to the function.
- Performs quality assurance functions in all aspects of technical services
- Deliver projects on-time with minimal needed oversight or supervision
- Coordinate and prioritize business needs in a matrix management environment.
- Individual Contributor Role, however possess an established ability to work independently or as part of the team
- Write regulatory-based documents (protocols, clinical study reports including patient narratives, annual safety reports, periodic safety update reports, integrated safety and efficacy reports, clinical trial registry summaries, and submission documents) for submission to regulatory agencies and medical institutions
- Write clinical documents associated with submissions to regulatory authorities including but not limited to: model informed consents, interim and final clinical study reports, and safety update reports
- Ensure document content and style adheres to FDA/EMA/world-wide regulatory agencies or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and style guidelines.
- Conduct quantitative and qualitative analyses on findings and present and interpret results in a structured, conclusion-oriented manner, to address key project objectives
- Perform literature searches/reviews as necessary to obtain background information and training for development of documents.
- Review statistical analysis plans and mock statistical output to assist in determining appropriateness of content/format for clinical writing
- Initiate and manage development of formats, templates and general guidelines for clinical documentation and workflow procedures. Assist in the development of departmental SOPs.
- Assist management as needed with preparation of resourcing estimates for potential new medical writing projects.
- Initiate and participate in departmental or interdepartmental process improvement and training initiatives
- Keep abreast of professional information and technology through workshops and conferences, and ensure the appropriate transfer of that information to the function.
- Performs quality assurance functions in all aspects of technical services
- Deliver projects on-time with minimal needed oversight or supervision
- Coordinate and prioritize business needs in a matrix management environment.
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