Joel Harder

Experience

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  USDA

  Jan 1992 - Jan 1995

  Research Technician

  • Dissected15,000 insect guts. Performed laboratory techniques to measure insect growth hormones in 100 samples after exposure to novel pesticides. Published in a Peer-Reviewed Entomology Journal. Recognized for Technical Performance.• Performed laboratory tests and experiments, analyzed data and results, and reported findings.• Prepared and maintained records and documents related to scientific research• Developed and implemented protocols for laboratory operations.• Performed administrative tasks such as managing large databases and organizing files Show less

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  Cambrex

  Jan 1996 - Jan 1997

  Quality Assurance Associate

  • Developed and implemented quality control objectives and protocols, in line with best practices, to ensure all products meet required standards.• Monitored daily production activities and provided feedback to management on any discrepancies or deviations from established protocols.• Conducted regular audits to review and evaluate processes for effectiveness and to ensure compliance with client requirements, clinical trial, and cGMP regulations.• Investigated customer complaints and implemented corrective actions as necessary. Show less

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  American Red Cross

  Jan 1997 - Jan 2005

  • Reviewed and approved over 1000 marketing materials for compliance with U.S. Food and Drug Administration’s Advertising and Promotional Material regulations.• Successfully passed hundreds of FDA reviews and compliance audits of blood donor appeal broadcast, print, and digital assets of U.S. based media. • Reviewed and approved 100+ validation plans designed to collected data to assure facilities, processing and testing equipment used at 8 National Testing Labs and 30 Regional Blood Banks supplying 40% of the U.S. blood supply works as intended.

  • Quality Assurance Technical Policy & Promotions Officer

    Jan 2002 - Jan 2005

  • Senior Quality Assurance Engineer

    Jan 1997 - Jan 2002
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  NCQA

  Mar 2005 - Apr 2006

  • Coordinated with other departments to ensure accuracy and timeliness of financial information.• Analyzed financial data to identify trends and make recommendations for improvement.• Prepared financial reports and presentations for external stakeholders. • Maintained the budgeting process and projections for products and services generating revenue of $21M. • Audited Institutional Review Board operations at 20 Veteran Administration Medical Centers to ensure compliance with all applicable laws, regulations and accreditation standards.• Prepared and submitted reports to stakeholders regarding the medical center's accreditation.• Developed and implemented policies, procedures and processes to ensure compliance with accreditation standards.

  • Health Plan Accreditation Manager

    Sept 2005 - Apr 2006

  • Human Research Protection Accreditation Analyst

    Mar 2005 - Aug 2005
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  Heart Rhythm Society

  Apr 2006 - Nov 2009

  Director, Quality Improvement & Outcomes

  •Raised $1.5 M in grants for a healthcare quality initiative impacts specific Medicare beneficiaries who have undergone a medical procedure for an implantable cardioverter defibrillator.•Led a private-public coalition achieved consensus on the first 5-year longitudinal, post-market, clinical research study using a nationwide clinical data registry using the Medicare policy Coverage with Evidence Development.

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  Society for Cardiovascular Angiography and Interventions

  Nov 2009 - Oct 2017

  Director, Clinical Guidelines & Quality Initiatives (Registered Lobbyist)

  •Directed and mentored three Managers; aided in development leading to highest performance ratings.•Authored quality and regulatory internal policies, procedures, and systems, and provided training to staff and physician members.•Turned a struggling clinical publication department into a highly successful member service exceeded budgeted revenue by $125,000. Further, products produced increased education income from $125,000 to $350,000 annually.•Deep understanding of government relations, including effective lobbying strategies, grassroots organizing, and the mechanics of policy-making. Crafted policy solutions to positively influence federal agencies to simplify regulations and reduce the overall cost of compliance.•In-depth understanding of U.S. Food and Drug Administration’s operations, laws, regulations, scientific issues, and sub-regulatory processes for drugs, biologics, and medical devices, including clinical trials and post-market surveillance. •In-depth understanding of the U.S. Centers for Medicare and Medicaid Services’ operations, laws, regulations, scientific issues, and sub-regulatory processes for Medicare, with special emphasis on medical devices. Show less

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  The Alliance for the Implementation of Clinical Practice Guidelines

  Oct 2018 - Mar 2021

  Executive Director | Nonprofit Founder

  •Established and built relationships with top leaders in the market, including those representing the highest levels in business, government, and non-profit sectors, growing doubling membership each year during COVID-19•Set and drove overall business vision, strategy, and decision-making across all functional areas, including legal structure, board formation, business development, finance, product, technology, marketing, and operations.

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  Colonel Rod Honeycutt for Congress, North Carolina's 11th District

  Nov 2021 - Jun 2022

  Policy Advisor

  •Prepared policy and position statements regarding candidate’s views on 13 federal agencies, 30 issue-based questionnaires sponsored by interest groups seeking information in context of pending endorsement. •Held over 200 candidate briefings to discuss sensitive issues, efforts to secure 18 endorsements, and intelligence gathered from 110 influencer events about the shifting political terrain in 17 counties.•Capitalized on rapid response opposition research to gain earned media in nightly news interviews, dozens of opinion articles, and an on-line international publication with influence in the primary.•Fundraised 10% of campaign donations in compliance with campaign finance laws through on-line engagement and influencing repeat donors. Show less

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  Self-employed

  Jul 2022 - now

  Healthcare Consulting