Regulatory Affairs Associate Jobs
Cincinnati, OH
Job Summary
The Associate Director Clinical Regulatory, is responsible for the effective and efficient utilization of regulatory personnel and resources related to the area of regulatory support for clinical trials, covering clinical regulatory document collection, submissions for Clinical Trial Authorization and submissions to ECs/IRB. ?This responsibility includes close working relationships with members of the clinical regulatory department, with respect to contracts administration and document management functions, as well as other department members and clients. ?The Associate Director Clinical Regulatory, is also responsible for the management of regulatory personnel and assuring that the various departmental tasks are completed in conformity with all Kendle policies/SOPs and government regulations
Core Responsibilities
- Accountable for day to day running of their team, personnel and projects.
- Implementation of company standards/policy within OU.
- Acts as a resource for industry knowledge and technical knowledge.
- Contributes to the completion of organizational projects and goals within a specified time frame.
- Develops solutions to a variety of complex problems.
- Provide general, development and regulatory advice to both clients and Kendle associates on matters relating to clinical trial regulatory.
- Determine staffing/resource needs within their groups and contribute to the selection of staff for project teams for clinical studies.
- Contribute to long term planning of OU.
- Responsible for leading designated projects and direction of team members to complete projects on time, to both cost and quality requirements (including QA of documentation as necessary).
- Responsible for the development and mentoring of group members, including discipline, and appraising the quality and performance of their work.
- Monitor expenditure against budgets.
- Act as a key point of contact for clients, regulatory authorities and senior managers within the Kendle organisation.
- Arrange, lead and report on client meetings, providing managerial supervision as necessary.
- Arrange, lead and report on meetings with regulatory authorities providing managerial supervision as necessary.
- Contribute to design of training programmes within specialist areas and train staff both within team and OU, and Kendle globally as required.
- Act as a point of contact for Sponsor and Regulatory Competent Authority audits, within their area.
Skills & Attributes
Candidate/incumbent should also have previous proven experience in managing the preparation of clinical regulatory submissions. ?Experience working in an independent office environment, knowledge of the CRO industry, and strong management experience in a complex multi-process oriented environment in general is strongly desired. ??Excellent leadership and decision making skills are required. ?The ability to understand, organize and supervise staff to work concurrently on several projects, each with specific requirements that may differ from project to project. ?Candidate/incumbent should be attentive to detail, flexible, open to suggestions, and possess excellent written and verbal communication skills. ?Candidate/incumbent should be able to interact with staff from multiple departments and Kendle offices to establish project standards. ?Some computer literacy in MS Word, Excel and PowerPoint is desired.
For more information please call 800-733-1572
