- Follow appropriate regulatory guidelines and templates
- Assist with assessing client efficacy data (data gap analysis and preliminary risk assessments) for the active substance and/or product dossiers under the focus of appropriate and specific regulatory requirements
- Review and check raw data and statistical analyses to prepare / produce data summaries for insertion into dossier's
- Assist with preparation of summary tables in required format, interpretation and assessment of scientific / biological data together with a detailed critical assessment to assure scientific rigor, accuracy and clarity of presentation of results
- Format and compile dossiers within agreed time schedules
- Assist with validating strategies to assist clients in dossier preparation including experimental programs according to European and national data requirements
- Make recommendations on / assist in furthering levels of standardisation and consistency within the team
- Maintain close liaison with study management staff to ensure studies which form part of submissions are reported with accuracy / timeliness
- Attend and actively participate in internal / external training, Efficacy conferences, seminars but also clientsâ meeting as required
- Support in visit to clients if needed
Managerial responsibilities:
- Occasional supervision of students and/or temporary staff as and when required
- Support in organising / participate in team meetings / technical meetings as and when required