1) Legal & Ethical Compliance
2) Innovative Business & Legal Solutions for QPharma’s Lines of Business
3) Continuous & Never-Ending Improvement.
As Chief Legal Officer, I serve as legal advisor to QPharma - (a software services provider for life sciences/pharmaceutical industry) - and executive leader for the Legal Department.
I am responsible for efficient contract management, minimizing risk, and ensuring regulatory compliance (e.g. HIPAA, Sunshine Act, Anti-kickback/False Claims Act statutes, Stark Law, FCPA, GDPR, etc.) for QPharma and its services rendered within the pharmaceutical/life sciences industry.
Working closely with Chief Technology Officer and IT staff to ensure and negotiate technology/software technology contracts between QPharma, its clients/partners and vendors.
Spearheaded and implemented GDPR.
Managing QPharma's privacy program, data protection, and related risk components in collaboration with our Chief Compliance Officer.
Alongside CEO and CFO, I handle various aspects re Mergers & Acquisitions as well as related licensing matters.
Investigates internal legal/ethics complaints, as well as handling DEA warehouse audits, reporting to Chief Compliance Officer.
Working alongside Director of Communications and other commercial sales/marketing team members, I help to drive review of marketing and promotional materials.
Collaboration with Chief Compliance Officer to ensure and facilitate supply chain compliance with respect to the FDA, Codes of Federal Regulation, Drug Supply Chain Security Act, and other legal authorities. Further providing advice on GMP regulatory issues.
Drafting and negotiating a generous range of complex, commercial agreements with a particular focus on SaaS, software licensing, wholesaler distribution arrangements, and other GxP arrangements.
Delivers ongoing HIPAA risk assessments and related compliance implementation.