Compliance Specialist (LISLE-2020-01)
Anju Software, a life science software company, is in search of dynamic, innovative driven individual to be a key enabler for company’s operational excellence and a trusted driver to enable our customer’s success and growth. The Compliance Specialist is responsible for assisting in the implementation and oversight of the compliance program across all departments at Anju Software. The Compliance Specialist must be able to communicate effectively across all levels within the organization on a wide variety of topics. As well as manage the balance of follow-up with diplomacy and tact. The Compliance Specialist must also be well versed in working with Standard Operating Proceedures (“SOPs”), Work Instructions (“WI”), both internal and external audits and general compliance regulations.
Anju Software is a leading provider of comprehensive software and data solutions to the life sciences industry. Anju has combined deep industry and software domain expertise to build a next generation platform for the life sciences sector that can scale to provide solutions that meet customers’ needs.
Professional, adaptability, possess strong teamwork building capabilities; excellent time management skills; strong communication skills to articulate complex issues; self-starter with ability to work within a large team environment. Experience using the TrialMaster suite of applications, excellent presentation and interpersonal skills are required.
- Coordinate and/or overseeSOPmanagement process, including SOP/WI list maintenance and tracking, training, version control, and bi-annual revision schedule.
- Participate in Compliance Committee activities as a committee member; coordinate meetings, prepare agendas, minutes and action items.
- Coordinate and/or perform internal audits against SOPs, regulations, and internal processes.
- Coordinate and/or perform vendor audits
- Coordinate audit activities and scheduling with external auditors.
- Track, collect and prepare audit responses as well as corrective actions.
- Prepare external audit response and follow-up supporting documentation and pro-active corrective action status reports to clients.
- Compile company compliance status reports for review by Senior Management.
- Ensure timely training of procedures for all employess including new hire orientation and onboarding.
- Work with Director of Complince and Compliance Committee to ensure compliance adherence across the organization.
- Follow up with employees to ensure adherence to SOPs.
- Share knowledge of GCP, FDA regulations, quality assurance concepts, SOPs, and auditing techniques.
Minimum Requirements (Education, Experience, Certifications):
- Bachelor’s degree or 3 years working in the clinical trial industry using EDC software.
- Minimum of two years direct experience in related fields in the medical industry.
- Strong knowledge and understanding of GCPs, FDA regulations, quality assurance concepts, SOPs, and auditing techniques.
- Excellent verbal and written communication skills.
- Excellent presentation skills in small and large group situations.
- Strong ability to establish direction and to motivate, and inspire team members.
- GDPR and EU-U.S. Privacy shield knowledge a plus.
- Responsible for the coordination and completion of compliance documents for all business units in OmniComm as directed by the Director of Compliance.
- Prior experience with software development a plus.
Knowledge, Skills & Abilities:
- Must have highly developed interpersonal skills with the ability to successfully collaborate with peers and cross-functional teams in order to achieve defined goals.
- Excellent presentation skills and understanding of appropriate communication methods within all organization levels.
- Must be highly skilled in both written and verbal communication , with the ability to clearly present to both technical and non-technical audiences.
- Ability to understand, interpret and train management and staff on industry regulations, quality concepts and guidelines.
- Prior experience in development and execution of internal training, presentation of quality and compliance strategies preferred.
Job Type: Full-time
Location: Lisle, IL Office
Salary: Based on experience