Location
Bangalore | India
Job description
The Medical Writer is in charge of producing medical writing deliverables (both regulatory and medical communication documents) with experienced and well-defined input.
The Medical Writer will draft the medical documents required for clinical research, such as the protocol, the study report, and the informed consent form.
The Medical Writer will work alongside healthcare professionals, project managers, biostatisticians, and other company functional groups to produce the medical writing deliverables.
General Responsibilities/Tasks:
- To write and edit medical writing deliverables (including clinical study protocols and clinical protocol amendments, informed consent forms, clinical study reports, clinical evaluation reports, CTD submissions, Investigator Brochures, Lay Summaries as well as clinical journal manuscripts, clinical journal abstracts, posters, literature reviews and client presentations) according to the sponsors and Excelya s SOPs.
- To contribute to document quality control (reviewing data accuracy, formatting and appropriateness of language, and compliance to industry guidelines).
- To maintain familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
- To liaise with other functional groups or departments (e.g., data management, statistical programming, biostatistics, project management) to ensure timely delivery and quality of writing deliverables.
Education Work experience
- University graduate in life sciences or equivalent (post-graduate studies in a relative field are considered a plus).
- Relative experience 3-4+ years in a medical writing or equivalent.
- Analytical skills and ability to interpret data.
- Attention to detail.
- Intellectual curiosity and creativity.
- The ability to work effectively in a team in a fast-paced and dynamic environment.
- Advanced level of English.
Job tags
Salary
