Scott Willoughby

Scott Willoughby Email and Phone Number

Pharmcaeutical and Medical Device Compliance Consulting @
Scott Willoughby's Location
Lawrence, Kansas, United States, United States
Scott Willoughby's Contact Details
About Scott Willoughby

I am a licensed attorney and a registered pharmacist and have spent over 25 years in the healthcare industry, 15 years as in house counsel including time as General Counsel of Rugby Labs and Otsuka America Pharmaceuticals. My practice was focused on FDA related issues,(advertising and promotional activities and drug safety), managing internal investigations and litigation. I joined the Pharmaceutical Research and Manufacturers of America (PhRMA) as Associate General Counsel. While at PhRMA, one of my primary responsibilities was coordinating the efforts of the member companies to draft the first PhRMA Code of Interactions with Healthcare Professionals. Since leaving PhRMA, I provided consulting expertise to many pharmaceutical and medical device companies for compliance with the PhRMA code on Interactions with Healthcare Professionals, the AdvaMed Code and related laws and regulations. Areas where I have provided consulting expertise include sales and marketing compliance, medical science liaisons activities, educational grants, selection process for investigators for clinical trials and grants for investigator sponsored trials. I recently started the consulting group of Scott Willoughby Assoc which provides expert consulting advice in a number of key areas to pharmaceutical and medical device companies. Those areas include: Sales and Marketing compliance assessments Speaker program process review, audit and monitoring Advisory board process review, audit and monitoring Review of third party vendor compliance with adverse event reporting requirements MSL activity assessments Clinical trial site selection process Educational grant policy review and modification IST grant selection process review and modification Independent review of clinical trial processes registers and registries Serving as the legal representative on promotional review committee Conducting independent investigations of hotline and other compliance complaintsSpecialties: Compliance consulting, SOP and policy drafting,conducting compliance related investigations, promotional material review (DDMAC), auditing and monitoring of compliance related matters,

Scott Willoughby's Current Company Details
Scott Willoughby Associates

Scott Willoughby Associates

Pharmcaeutical and Medical Device Compliance Consulting
Scott Willoughby Work Experience Details
  • Scott Willoughby Associates
    President
    Scott Willoughby Associates Apr 2009 - Present
    Scott Willoughby Assoc is a consulting firm that assists pharmaceutical and medical device companies with compliance issues and programs, conducts internal investigations and provides promotional material review for DDMAC/OPDP compliance.
  • Biogen Idec
    Vp, Chief Compliance Officer
    Biogen Idec Aug 2007 - Sep 2008
    Cambridge, Ma, Us
    The position was responsible for the development of the global complaince program which included the commercial activities, SOX compliance, and R&D, as well as investigations.
    View
  • Huron Consulting Group
    Managing Director
    Huron Consulting Group Feb 2005 - Aug 2007
    Chicago, Il, Us
    Led teams of professionals that provided assistance to pharmaceutical and medical device companies for compliance with the PhRMA Code, AdvaMed Code and related state and federal laws and regualtions. The teams assisted in the development of methodology to determine Fair Market Value for services provided by healthcare professionals.
    View
  • Otsuka America Pharmaceutical, Inc.
    General Counsel
    Otsuka America Pharmaceutical, Inc. 1995 - 2002
    Princeton, Nj, Us
    View
  • Marion Merrell Dow
    Attorney
    Marion Merrell Dow 1985 - 1995

Scott Willoughby Skills

Fda Pharmaceutical Industry Clinical Trials Medical Devices Sop Healthcare Management Program Management Auditing Litigation Internal Investigations Pharmaceutics Sarbanes Oxley Act Private Investigations Regulations Public Speaking Regulatory Affairs Licensing Intellectual Property Mergers And Acquisitions Fcpa

Scott Willoughby Education Details

  • Washburn University School Of Law
    Washburn University School Of Law
    Law
  • The University Of Kansas
    The University Of Kansas
    Pharmacy

Frequently Asked Questions about Scott Willoughby

What company does Scott Willoughby work for?

Scott Willoughby works for Scott Willoughby Associates

What is Scott Willoughby's role at the current company?

Scott Willoughby's current role is Pharmcaeutical and Medical Device Compliance Consulting.

What is Scott Willoughby's email address?

Scott Willoughby's email address is sc****@****ast.net

What is Scott Willoughby's direct phone number?

Scott Willoughby's direct phone number is +130166*****

What schools did Scott Willoughby attend?

Scott Willoughby attended Washburn University School Of Law, The University Of Kansas.

What skills is Scott Willoughby known for?

Scott Willoughby has skills like Fda, Pharmaceutical Industry, Clinical Trials, Medical Devices, Sop, Healthcare, Management, Program Management, Auditing, Litigation, Internal Investigations, Pharmaceutics.

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