Heidi Scheer

About Heidi Scheer

Project manager with combined healthcare and phase 1-3 clinical research industry experience. Focused on following IRB & HIPAA regulatory compliance while maintaining quality assurance. My many years of direct patient care with focus on geriatric physical therapy together with a graduate degree in gerontology have given me a special interest in aging adults. I am confident in my ability to help clients accelerate their regulatory documentation management for pharmaceutical study findings and scientific publications. Versatile detailed writing and research skills, with extreme proficiency in technical writing, content and project development and management. Work includes co-author of journal contributions as well as an academic textbook chapter for Wiley. Comprehensive medical industry knowledge and terminology fluency, and the ability to effectively convey complex concepts. In both direct patient care and during research work delivered effective support of clients and patients, trained and supervised study participants ensuring quality control, and delivered project management leadership in developing and instituting SOPs. Personnel management on a fast paced Covid study for a team of 50+ clinicians. As a Director of Customer Service for an international manufacturer established and monitored policies and QA reports for production teams, while maintaining high level competency in understanding technical terms to support manufacturer and retail customer. My clinical professional experience demonstrates my skills collaborating with multi-disciplinary healthcare teams, as well as my ability to communicate effectively with a variety of stakeholders. I am able to conduct holistic assessments for the geriatric community, identifying the needs of each individual and providing appropriate care plans and resource connections.

Experience

1. Regulatory Operational Liaision

   Chiesi Group

   Feb 2024 — Present · US

   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

Education

• University of North Carolina at Greensboro

  Master of Science - MS

  2017 — 2019