Essential Job Duties:
- Assume the role of study QC Auditor for allocated studies
- Oversee the Medical Writing Quality Control Group (MWQCG).
- Peer review of others work, providing feedback and training as appropriate.
- Manage a team of QC Reviewers to include managing performance, goals and objectives, mid year and end of year reviews, regular catch-ups and status meetings. Review any individual issues with staff proactively and in a timely fashion. Coach team members on an ongoing basis to resolve issues in a supportive manner.
- Work with Clinical and Nonclinical Writing Groups to establish procedures for the efficient QC of documents.
- Work with Clinical and Nonclinical Writing Groups to schedule the QC of documents.
- Develop and maintain Covance QC templates and tracking documents.
- Work with Clients to develop client-specific QC processes and procedures, including client-specific QC checklists.
- Schedule QC across multiple projects and track progress against project milestones.
- Proactive involvement in process improvements.
- Good time management and organization skills, the ability to prioritize own work to meet tight deadlines while maintaining the highest standards of work.
- Effective communication skills; a co-operative and team orientated approach.
- Perform other related duties as assigned.
- BS degree or higher in related science/regulatory affairs.
- 1-2 years of QC experience.
- Other required work-related experiences:
- successful team leadership experience;
- PLD if possible;
- leadership development training as soon as possible upon promotion;
- training and facilitating training;
- excellent communication skills;
- ability to successfully manage multiple priorities and deadlines;
- experience developing and improving work and work-sharing processes.
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