Heidi Scheer Email & Phone Number

United States

Act as blinded/unblinded contact for safety submissionsCoordinate with the Therapeutic Areas re: the maintenance of clinical/regulatory document exchange locationsCreate periodic trainings on global regulatory requirements for clinical and PV documentation.Develop and review procedures, SOP and templates related to GxP processes shared with other GxP departs.Track and support the company and product renewal planning process including, extraction of information from RIMS, consolidation, distribution, and timeline expectationsPerform extractions from RIMS for GPV purposes. Ensure extraction, elaboration, and quality check of product registrations worldwide or KPIs (e.g. related to safety variations submission) from RIMS to be included in the Pharmacovigilance System Master File.• Organize and contribute to lignment meetings with GPV, GMD, GPV, and compliance to ensure alignment on the interface activities and continuous improvement of shared processes• Open and manage GxP deviations and ensure any department CAPA plan implementation• Support the GxP audit & inspection related activitiesAct as GRA resource for GCP and PV documentation questionsSupport cross-department on clinical and PV document timelines and milestones to facilitate prep of submission packetsCoordinate with TAs to provide regulatory documentation for TMF and for CTS releaseCoordinate with TAs to collect and perform quality review of required clinical trial documentation supporting global drug development for regulatory compliance/submissionCollection and tracking of NCT number from GCD for appropriate FDA formsCoordinate with TAs and GCD to ensure tracking of Financial Disclosure documentation for submission package and generation of documentation necessary for Financial Disclosure CertificationCoordinate with TAs and GCD to compile non-IND site information to enable use of historical ex-US clinical data in US marketing application per 21 CFR 312.120

Durham County, North Carolina, United States

Rtp-Usa

Project management and oversight. Writing and editing. Process review and improvement.

United States

Uncg

Facilitated and created comprehensive report analyzing implementation of the Otago Exercise Program (OEP) at national level. Report created on behalf of University of North Carolina-Chapel Hill’s Center for Healthy Aging and National Council on Aging’s(NCOA) National Falls Prevention Resource Center, in support of the U.S. Administration on Aging (ACL) falls prevention grantees. •Created questionnaire conducted with U.S. Administration for Community Living falls prevention grantees for analysis of program implementation, including successes, failures, lessons learned, and recommendations for payment models including reimbursement from Medicare/health care insurers. •Synthesized information in comprehensive report for NCOA. Evaluation includes case studies and proposals for decreasing barriers for use of OEP. Model offered to create feedback loop ensuring consistent delivery and maintenance. Written report and PowerPoint presentation provided.

Collaborated with team on projects, program development, and research for Project ABLE. Roles included participant recruitment and engagement, baseline cognitive screenings, participant intake training and monitoring of subjects. Designed protocols and operating procedures manual. Cultivated site relationships throughout project while ensuring IRB and study protocol compliance. Data input and management throughout study cycle. Responsible for adapting techniques for participant interface to improve study management.•Facilitated training for participants, ensuring comprehension of study procedures following regulatory guidelines with human subjects.•Partnered with study lead/PI to design SOPs ensuring consistency of data and research methods. •Credited co-author on multiple works related to this study.

Greensboro/Winston-Salem, North Carolina Area

My role from 2010-2017 included contracts with:Legacy Healthcare Services: Countryside Village/Select Rehabilitation: Piedmont Crossing (2016 to Present) Piedmont Home Care (2015 to 2017) 5-star Rehab & Wellness/Ageility Physical Therapy Solutions: Morningview & Carriage House (2017) Advanced Home Care (2010 to 2012) Heritage Health Care: Wellspring, Clapp’s, Riverlanding, & Twin Lakes (2010 to 2017)Implemented direct patient care under time-focused guidelines within home health, assisted living, and skilled nursing settings. Provided superb direct patient care while establishing and sustaining relationships with patients and care team members. Supported patient advocacy in care team meetings and within community. Ensured strict compliance with all regulations, including HIPAA and clinical training guidelines for documentation and client billing coding to meet Medicare reimbursement approval. •Contributed to multidisciplinary team meetings, focused on providing quality care while following adherence to designed treatment models and best practices. •Developed and implemented comprehensive understanding of specialized treatment methods for patients with dementia.•Concise and accurate documentation of patient care meeting both company and Medicare/insurance guidelines.

Greensboro/Winston-Salem, North Carolina Area

Facilitated social services support of children in foster care in partnership with court systems throughout Guilford County. Built key relationships with Department of Social Services personnel, district court judges, and other community partners. Advocated on behalf of children, as well as assessed individual child long-term needs and care options. Served as primary point of contact and advocate for well-being of foster children, connecting children with resources through DHHS (Department of Health and Human Services) and court system.

North Carolina/South America

Directed customer service operations, quality assurance measures, and product support for global product portfolio sold through Home Depot and Lowes retail stores. Named product support liaison for cultivating robust relationships with manufacturers, retailers, and consumers. Communicated effectively with consumers and B2B partners on product concerns, assessing feedback and determining issue resolutions. Established and monitored policies for division, ensuring team member adherence. Generated marketing material, customer service scripts and QA reports for factory production teams, as well as conducted onsite quality inspections of factories and stores to ensure alignment with brand standards. Responsible for direct response materials and strategies to increase product sales during seasonal promotions in support of vendor product marketing.•Supervised, trained, and mentored warehousing and production teams. •Maintained adherence to contractual agreements, and drove profitability and revenue when possible.•Oversaw product failure budgetary overage return rate costing and inventory adjustments.