Regulatory Affairs Specialist (Madison, WI)
Forte is the industry-leading provider of software and services in the critical areas of clinical trial management, clinical data management and research administration for cancer centers, academic medical centers and health systems.
Essential Job Duties (in order of priority)
- Work with all Forte team members to collect Quality and Information Security Management System (QISMS) input, update existing process, work instruction and guidance documentation.
- Design and execute on internal audit plans of systems and processes
- Develop new tools to support QISMS implementation (new guidance docs, flowcharts, etc.)
- Review and revise documentation related to Forte compliance and regulatory affairs.
- Manage new team member and existing team member update QISMS training activities and records.
- Monitor the corrective action log and work with corrective action owners to complete agreed upon activities.
- Assist with annual QISMS monitoring activities such as internal and vendor audits.
- Participate in and assist with coordination of external QISMS audits.
Job Qualifications & Job Evaluation
Documentation: The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Bachelor’s degree preferred; or equivalent work experience
- 2 – 5 years of previous experience in an FDA-regulated environments or ISO-9001/27001 certification.
- Previous experience with a software company and software development lifecycle processes.
- Prior process development experience a plus.
Knowledge, Skills & Abilities
- Ability to provide and elicit appropriate feedback to and from team members.
- Innate curiosity about processes and systems.
- Demonstrated ability to analyze problems and understand the necessary components of a solution through analysis, planning, and evaluation of cost/benefit.
- Excellent communication skills, including listening, writing, and speaking. Must demonstrate the ability to confer detailed process and workflow instructions.
- Effective technical writing skills including previous experience in writing procedures or processes.
- Ability to assess the stakeholders understanding of process and the desired outcome.
- Demonstrated ability to effectively negotiate and build consensus with various audiences, plan and manage project activities while facilitating and developing business strategy through internal and external relationships.
- Willingness to embrace and drive change.
- Demonstrated accountability in project ownership and solution-oriented work approach.
- Proficient in the use of Microsoft Word, Excel, Visio and PowerPoint. Proficient in email.
Licenses & Certifications
- None required
- Ability to lift 25 pounds