PRECLINICAL MEDICAL WRITER
Posted on Jan 21, 2020 by Stamford Consultants AG
- Serve on early development teams as preclinical medical writer for a wide range of therapeutic areas
- Write preclinical modules of regulatory documents (IB, IND, NDA/MAA) and publications
- Compile, edit, and manage review of preclinical documents authored by cross-functional teams
- Edit and format nonclinical research reports
- Coordinate overall quality control review of nonclinical sections of regulatory documents
- Perform quality control checks for internal consistency of data, accuracy and completeness of content, compliance with Idorsia style guides etc.
- Supervise the tracking and archiving of nonclinical documents in electronic databases
- Manage nonclinical templates, forms, and SOPs
REQUIRED QUALIFICATIONS AND EXPERIENCE
- Masters or PhD in the life sciences
- 1-2 years of medical writing experience highly desirable
- English fluent or comparable level of spoken English and excellent English writing skills
- Ability to correct grammar and usage and ensure logical and coherent presentation of scientific information in documents
- Good analytical skills and ability to interpret data
- Ability and interest in writing and editing a wide range of documents
- Open to learning and able and interested in working in diverse scientific fields
- Ability to work independently and with teams from different functional areas (eg, preclinical and clinical research, regulatory, communication)
- Ability to prioritize and work on multiple projects at a time
- Must have good organizational skills, be flexible, and be able to work under strict timelines
- Sharp eye for detail, but still able to see the big picture
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