Ed Johnson

Ed Johnson Email and Phone Number

Principal at Edward J. Johnson, LLC @ Axendia, Inc.
Ed Johnson's Location
Greater Philadelphia, United States, United States
Ed Johnson's Contact Details

Ed Johnson personal email

Ed Johnson phone numbers

About Ed Johnson

• Extensive experience in counseling pharmaceutical, medical device, diagnostics, and healthcare IT companies on legal and compliance issues, regulatory strategies, and general corporate and transactional matters. • Strengths in advertising/promotion, clinical R&D, software/services licensing and technology transfer for the pharmaceutical, medical device, diagnostics and healthcare IT industries. • Responsible for legal and compliance aspects of corporate quality systems, regulatory affairs departments, professional education/training programs.• Experienced public speaker and writer; liaison experience with national and international regulatory bodies and industry consortia.Practice focus: advertising/promotion/speaker programs/KOL/advisory board compliance, including agreements; GMP/QSR compliance; vendor/outsourcer/supply chain transactions including licensing and joint ventures, qualification and compliance; pharmaceutical/medical device/CRO transactional matters; due diligence activities.

Ed Johnson's Current Company Details
Axendia, Inc.

Axendia, Inc.

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Principal at Edward J. Johnson, LLC
Ed Johnson Work Experience Details
  • Edward J. Johnson, Llc
    Principal, Counsel
    Edward J. Johnson, Llc
  • Edward J. Johnson, Llc
    Principal, Counsel
    Edward J. Johnson, Llc Aug 2009 - Present
    Serve as retained outside general counsel to pharmaceutical, medical device, diagnostics and life sciences companies.Draft/review/negotiate clinical trial sponsor agreements, speakers bureau/KOL agreements, master services (including SaaS) agreements, confidentiality and non-disclosure agreements, employment agreements (including HCEs), letters of intent, materials transfer agreements, and licensing/sublicensing agreements for pharmaceutical, medical device and biotechnology companies and CROs. Guide development/review content of advertising and promotional materials, scientific publications, advisory boards, speaker training, social media policies for FDA/OPDP, AdvaMed and PhRMA Code compliance. Consult on pharmaceutical, medical device and healthcare IT legal and regulatory issues.
  • Axendia, Inc.
    Of Counsel
    Axendia, Inc. May 2010 - Present
    Yardley, Pa, Us
    Retained to identify and analyze legal issues, and assure legal and regulatory compliance for life sciences consulting firm. Advise company and clients on legal and regulatory compliance strategy, including interpretation of FDA guidance and enforcement action.
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  • Siemens Healthcare
    Clinical Regulatory Affairs
    Siemens Healthcare Mar 2007 - Jun 2009
    Forchheim, De
    Ensured compliance of processes, organization, and solutions to global medical device regulatory requirements from concept to end-of-life. Drafted regulatory-related artifacts, including internal regulatory classification decisions, IDEs, 510(k)s, 513(g)s. Represented department in internal and external compliance assessments and audits. Responsible for regulatory compliance aspects of customer relationship management business process.
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  • Edward J. Johnson, P.C.
    Attorney, Regulatory Consultant, Industry Analyst
    Edward J. Johnson, P.C. May 2005 - Feb 2007
    Practice of food and drug law, software intellectual property law including licensing, technology transfer and life sciences services agreements. Consulting on regulatory compliance aspects of medical device and pharmaceutical quality systems and regulatory affairs departments and professional education/technical training programs.
  • Liquent (Thomson)
    Director, Regulatory Strategies
    Liquent (Thomson) Jun 2004 - May 2005
    Horsham, Pa, Us
    Director of regulatory compliance and regulatory strategic planning for company providing regulatory submissions products and services. Guided strategy for expanding product/service offerings into the medical device and combination products industries.
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  • Stelex
    Regulatory Affairs Counsel
    Stelex Jul 1997 - Jun 2004
    In-house counsel, compliance officer, quality systems auditor, head of regulatory consulting business unit, director of internal and external technical training/professional education programs.

Ed Johnson Skills

Regulatory Affairs Fda Medical Devices Regulatory Requirements Pharmaceutical Industry Biotechnology Quality System Gmp Strategy Clinical Trials Technology Transfer Lifesciences 21 Cfr Part 11 Drug Development Intellectual Property Pharmaceutics Compliance Licensing Capa Quality Auditing Regulations Change Control V&v Clinical Development Biopharmaceuticals Cro Risk Assessment Sop Pharmaceutical Law Policy Contract Negotiation Employee Management Public Speaking Advisory Boards Venture Financing Medical Diagnostics Contract Management Pharmaceuticals Contract Development Contract Review Employment Contracts Privacy Policies Salesforce Training Speaker Training Speakers Bureau Regulatory Strategy Marketing Communications Supply Chain Medical Grants Promotional Copy

Ed Johnson Education Details

  • The George Washington University
    The George Washington University
    Law
  • Emory University
    Emory University
    Chemistry
  • The University Of Georgia
    The University Of Georgia
    Chemistry
  • Aynor High School
    Aynor High School
  • Aynor High School
    Aynor High School

Frequently Asked Questions about Ed Johnson

What company does Ed Johnson work for?

Ed Johnson works for Axendia, Inc.

What is Ed Johnson's role at the current company?

Ed Johnson's current role is Principal at Edward J. Johnson, LLC.

What is Ed Johnson's email address?

Ed Johnson's email address is la****@****hoo.com

What is Ed Johnson's direct phone number?

Ed Johnson's direct phone number is +126735*****

What schools did Ed Johnson attend?

Ed Johnson attended The George Washington University, Emory University, The University Of Georgia, Aynor High School, Aynor High School.

What are some of Ed Johnson's interests?

Ed Johnson has interest in Antique Auto Restoration, Autism Research, Flatwater And Sea Kayaking.

What skills is Ed Johnson known for?

Ed Johnson has skills like Regulatory Affairs, Fda, Medical Devices, Regulatory Requirements, Pharmaceutical Industry, Biotechnology, Quality System, Gmp, Strategy, Clinical Trials, Technology Transfer, Lifesciences.

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