Job Summary
An international biopharmaceutical firm is searching for a person to fill their position for a Remote Associate Medical Writing Director.
Individual must be able to fulfill the following responsibilities:
- Work with cross functional team to ensure communication needs for clinical data are considered early in development program
- Work with the cross functional team to ensure effective communication of data in the respective documents
- Analyze study level documents for their ability to deliver the information required by the target audience (eg, health authorities)
Qualifications for this position include:
- Clear understanding of lean authoring for clinical regulatory documents
- A solid understanding of the clinical development process, including the documents that are required at each stage
- For early development: knowledge of pre-clinical and nonclinical regulatory requirements and reporting is required
- Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and templates