Role DescriptionThe roles offer the opportunity to work with ground-breaking products and manufacturing technologies, be involved with cutting edge science and develop new quality approaches.
ResponsibilitiesFull review of 12 reports with technical guidance and input from team to clean out inconsistencies and rewriting study report sections to fix them. You will interface directly with both internal and external stakeholders to get the report right. Your focus is on compliance. Your role is to ensure that the final versions adhere to a high standard in terms of completeness, accuracy, and compliance of data provided whilst keeping a close eye on timelines.
Requirements- MSc or PhD in biomedical or chemical field - Writing experience in industry (must) - Able to gain alignment on divergent issues, under guidance - Able to make sound judgments based on quality principles and to provide compliant solutions to problems. - The job holder should be an independent person and should be able to work constructively and negotiate with various parties throughout the organization - Knowledge of article 9 could be advantageous - Knowledge of clinical drug development and regulatory processes and procedures within clinical trials is advantageous but not required - must be able to organize multiple priorities and projects and work independently within area of responsibility - Planning & organization - Results oriented - Accuracy - Analytical skills, to be used to resolve complex issues - Communicative - Team player
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Rutger Koning.