Summary
Overview
Work History
Education
Skills
Websites
Timeline
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SUSAN Leonard

Basking Ridge,New Jersey

Summary

PHARMACEUTICAL ATTORNEY Solution-oriented, collaborative commercial pharmaceutical attorney with 20 + years as in-house FDA regulatory, fraud and abuse and privacy counsel in both Fortune 500 and growing pharmaceutical companies. Extensive experience in promotional review from concept through distribution of launch and established products for professional and direct to consumer advertising materials, including detail aids, email programs, coupon programs and websites, both branded and unbranded. A team player with a track record of supporting compliance and business clients in achieving their objectives. Solid written and oral communication skills, as well as problem solving abilities. Member of the Bar of New Jersey and US District Court of New Jersey. Available for part-time consulting opportunities.

Overview

22
22
years of professional experience

Work History

PHARMACEUTICAL ATTORNEY

  • Solution-oriented, collaborative commercial pharmaceutical attorney with 20 + years as in-house FDA regulatory, fraud and abuse and privacy counsel in both Fortune 500 and growing pharmaceutical companies
  • Extensive experience in promotional review from concept through distribution of launch and established products for professional and direct to consumer advertising materials, including detail aids, email programs, coupon programs and websites, both branded and unbranded
  • A team player with a track record of supporting compliance and business clients in achieving their objectives
  • Solid written and oral communication skills, as well as problem solving abilities
  • Member of the Bar of New Jersey and US District Court of New Jersey
  • Available for part-time consulting opportunities.

LEONARD PHARMA CONSULTING LLC
  • Provided and currently providing legal consulting services (remote and onsite) to the following pharmaceutical companies as member of promotional review teams for existing and new indications

BRACH, EICHLER, ROSENBERG, SILVER, BERNSTEIN, HAMMER & GLADSTONE, P.C.
  • Partner, Healthcare/Corporate, Associate

LOWENSTEIN, SANDLER, KOHL, FISHER & BOYLAN, P.A.
  • Corporate, Real Estate and Secured Transactions Associate

AVERITAS (Grunenthal)
01.2018 - Current
  • Partner with business units, regulatory and medical affairs colleagues in development of concept of ethical and DTC promotional materials for submission to FDA
  • Advise on commercial unbranded and branded marketing materials (both for HCPs and consumers)
  • Review branded and disease state promotional materials from concept through production and use by business on launch and established products
  • CVAs
  • Commercial and Corporate Websites
  • Conference materials (booth displays; handouts; speaker presentations
  • Speaker presentations; consulting agreement
  • Social media (Facebook; Linked In)
  • Patient testimonials
  • Co-commercialization of products.

ESPERION
01.2018 - 01.2019
  • Partner with business units, regulatory and medical affairs colleagues in development of concept of ethical and DTC promotional materials for submission to FDA
  • Advise on commercial unbranded and branded marketing materials (both for HCPs and consumers)
  • Review branded and disease state promotional materials from concept through production and use by business on launch and established products
  • CVAs
  • Commercial and Corporate Websites
  • Conference materials (booth displays; handouts; speaker presentations
  • Speaker presentations; consulting agreement
  • Social media (Facebook; Linked In)
  • Patient testimonials
  • Co-commercialization of products.

Senior Director, Hematology Franchise Counsel and Privacy Counsel

CELGENE CORPORATION
01.2011 - 01.2018
  • Served as lead commercial counsel for company’s myeloid and lymphoma franchises, in connection with a “Company first” co-commercialization of a new product
  • Reviewed branded and disease state promotional materials from concept through production and use by business on launch and established products
  • Provided compliance counseling to Digital Communications Team (Monitored live social media programs (Twitter Chat, Facebook Live) to prevent risk from posting of unsupported product claims and/or safety issues
  • Reviewed social media posts for compliance with FDA and general advertising laws
  • Drafted and negotiated vendor, services, consulting, license, data purchase, and other agreements, as well as compliance policies and procedures
  • Privacy: Provided counsel on all US and Canadian privacy related matters across company business functions (HR, medical affairs, commercial, public affairs, contracts
  • Co-drafted world-wide corporate privacy policy, website privacy policy and digital app privacy policies in collaboration with EU legal counterpart
  • Collaborated with EU legal counterpart on plan to implement GDPR
  • Applied US CAN-SPAM requirements to non-personal promotional materials (email campaigns).

Senior Vice President Privacy and Data Protection

ADVANCED HEALTH MEDIA (AHM)
01.2010 - 01.2011
  • Created and implemented effective privacy and data protection policies for the conduct of company’s logistics business (speaker programs, spend transparency, consultant meetings, website compliance).

Legal Director, Commercial Operations

DAIICHI SANKYO, INC.
01.2008 - 01.2010
  • Lead commercial counsel for company’s pharmaceutical brands, including billion-dollar hypertension franchise
  • Managed team of 4 commercial, regulatory attorneys
  • Member of Charitable Contributions Committee, General contract support across the organization
  • Engaged with counsel from co-promote company to plan co-promote activities, resulting in creation of company policies in alignment with co-promote company to avoid risk in promotional and other materials.

Legal Director, Global Law Department

SCHERING PLOUGH CORPORATION
01.2003 - 01.2008
  • FDA Regulatory and Fraud and Abuse: Provided regulatory counsel to multi-million-dollar product franchises in anti-infectives and men’s health, as well as issues of healthcare fraud and abuse
  • Advised on Federal and state healthcare laws and regulations (federal Anti-kickback Statute, False Claims Act, HIPAA, Medicare Modernization Act of 2003, Prescription Drug Marketing Act, OIG Guidance PhARMA Code, and Company’s Corporate Integrity Agreement
  • Focused on speaker, consulting, licensing, and service agreements, formulary placement pull-through materials, web-based, non-branded patient educational materials; sales training, coupon programs, market access rebate agreements
  • Provided general counsel to Public Affairs’ matters, including corporate giving strategy, revision of policies and procedures relating to charitable contributions and product donation, partnerships with not-for-profit organizations.

Education

Master of Arts - Russian Literature

New York University Graduate School of Arts And Sciences
New York, NY

A.B. -

Douglass College (Rutgers The State University)
New Brunswick, NJ

Juris Doctor (JD) -

Rutgers School of Law
Newark, NJ
01.1989

Skills

  • Legal analysis
  • 20 years experience
  • Oral and written skills
  • Collaboration
  • Legal writing

Timeline

AVERITAS (Grunenthal)
01.2018 - Current

ESPERION
01.2018 - 01.2019

Senior Director, Hematology Franchise Counsel and Privacy Counsel

CELGENE CORPORATION
01.2011 - 01.2018

Senior Vice President Privacy and Data Protection

ADVANCED HEALTH MEDIA (AHM)
01.2010 - 01.2011

Legal Director, Commercial Operations

DAIICHI SANKYO, INC.
01.2008 - 01.2010

Legal Director, Global Law Department

SCHERING PLOUGH CORPORATION
01.2003 - 01.2008

PHARMACEUTICAL ATTORNEY

LEONARD PHARMA CONSULTING LLC

BRACH, EICHLER, ROSENBERG, SILVER, BERNSTEIN, HAMMER & GLADSTONE, P.C.

LOWENSTEIN, SANDLER, KOHL, FISHER & BOYLAN, P.A.

Master of Arts - Russian Literature

New York University Graduate School of Arts And Sciences

A.B. -

Douglass College (Rutgers The State University)

Juris Doctor (JD) -

Rutgers School of Law

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