Michelle Wright Email & Phone Number

Montgomery County, Alabama, United States

Manage internal/external document retention, revisions and destruction processes including Standard Operating Procedures, Polices, WINS, Deviations, Change Control, CAPAs, Product Batch records, Regulatory FDA Submissions, Audit (internal and external) records. Facilitate and manage process flow of controlled operational, functional, regulatory, quality and marketing promotional materials from creation to retirement. Administrator/Superuser for dual-purpose Company web-based learning management and quality management system (ZenQMS) and Company promotional material management system (Veeva/Promomats). Administer all GMP, Regulatory, Pharmacovigilance, Compliance, Business Operations, Quality Assurance and product competency training and records for 300+ employees. Collaborate with Executive team, Department Managers and SMEs to develop, update, and revise training matrices for all employees/positions. Review/edit various corporate and controlled documents and trainings for content, formatting and grammatical errors prior to finalization.Prepare and assist in preparation of various Regulatory FDA IND/NDA Submissions and other State specific Compliance filings. Manage electronic IND/NDA filings and logs. Support Quality and Regulatory departments during external and internal supplier audits and regulatory authority (including but not limited to FDA, DEA, and other government and licensing agencies) audits/inspections. Identify, retrieve and review requested documents and record real time minutes, including document requests/submissions. Summarize multiple departments audit notes at conclusion. Assist with required responses and actions based on findings or improvement suggestions. Schedule and coordinate various Corporate and department meetings and functions (includes but not limited to location coordination, travel logistics, plan and arrange all catering needs and secure any additional necessary equipment or items needed for meeting or function).

Prattville, Alabama, United States

Front-line contact and control of access into C-suite. Provided executive administrative support to the hospital CEO and other C-suite members.Schedule, organize, attend, and scribe CEO involved meetings from Community support meetings to executive hospital business meetings such as Medical Executive Committee (MEC) and Hospital Advisory Board Meetings. Prepared agendas and meeting books for meetings, in addition to coordination of catering and any necessary meeting setup.Assisted in the handling of patient/family complaints working to reach a resolution.Prepared credentialing documents and files for new and renewing hospital privileges for 100s of physicians and allied health providers. Assisted hospital department Chief physicians who reviewed and approved provider credentials. Worked to research and address any issues or concerns found by department Chief physicians during credential file reviews. Presented HCP and allied health credentialing files to MEC for final approval or rejection. Maintained and updated information in hospital-wide credentialing system and prepared approval or denial of privilege letters and documentation to HCPs and allied health applicants.Assisted Quality Manager, Nurse Manager and Patient Advocate with the handling patient/family complaints and reaching a resolution. Participated in the creation, organization and production of hospital-wide educational training events, employee appreciation events, patient and employee morale events, holiday events for hospital staff (cookouts/bake sales/meals/parties for specific holidays and community events such as the Angel Tree and Living Tree Ceremony). Volunteered for a variety of community events to represent the hospital. Always focused on maintaining the highest level of confidentiality and HIPAA consciousness.

Montgomery County, Alabama, United States

Maintained the smooth operation of the daily office functions, answered multiline telephone addressing all callers with professionalism and careful consideration. Scheduled, and maintained Trial dockets for Domestic Relations and Child Support cases, approximately 1500 +/- cases a year. Scheduled and maintained Judge's professional and personal calendar. Maintained controlled, minimal access to Judge to avoid any opportunity for or appearance of ex parte communication or behavior. Drafted Orders per Judge’s notes and instructions, proof-read and edited Orders, ran trial docket, called cases, worked closely with Circuit and Juvenile Court Clerk’s offices, and other Court officials and employees, attorneys, and case participants to run cases from initial filing through to case disposition. Attended trial proceedings to provide administrative assistance to Judge, attorneys and parties (call witnesses, make copies, handle exhibits, etc.). Always focused on maintaining the highest level of confidentiality and integrity.

Montgomery, Alabama, United States

Managed and maintained general legal office activities. Managed receptionist and controlled access to attorney. Maintained personal and professional appointment and trial calendar for attorney. Answered multi-line telephone, made appointments, handled distressed, distraught and upset individuals on a regular basis. Provided advice, comfort and support to clients in variety of emergency and/or unpleasant, stressful situations.Conducted client and witness interviews, case preparation drafted legal documents including petitions, complaints, modifications, answers, discovery requests and responses, deposition notices, subpoenas and other legal pleadings. Served pleadings and subpoenas on defendants and witnesses. Worked with clients to gather documents requested through discovery and organized and prepared their discovery responses. Received, reviewed and organized incoming discovery responses. Identified, collected, reviewed and organized trial evidence and exhibits, including but not limited to financial and medical records. Perform extensive review of medical records for Social Security Disability clients. Identify pertinent information contained in medical records and prepare Summary/Brief on records. Attend trial, perform document management duties, note-taking and client and witness preparation and handling for trial. Prepare client billing and performed collections of outstanding accounts. Calmly handled any issues or situations that arose from general day-to-day operations of a domestic relations/family law/social security disability focused law firm all while maintaining the highest level of confidentiality and ethical treatment of each represented individual.