Essential Duties & Responsibilities
- Responsible for drafting and negotiating all Company contracts, including product licensing agreements, GPO contracts and wholesale distribution agreements, clinical trial agreements and indemnification agreements with clinical sites.
- Responsible for ensuring all contracts are timely entered into contract management system, compliance with the Company contracting policies and procedures and supervising administration of contract management system by paralegal.
- Responsible for review and approval of all marketing materials and medical publications, including flyers, packaging, labeling, promotional materials, presentations and catalogs for the sale and marketing of pharmaceutical products to ensure compliance with FDA rules and regulations. Work with Chief Compliance Officer and General Counsel to recommend, develop, review and adopt policies and procedures for the distribution, marketing and sale of pharmaceutical products to ensure compliance with federal and state legal requirements, including compliance with FDA rules and regulations.
- Serve as principal legal contact to resolve contractual issues that arise between the Company and its marketing partners, service providers and suppliers.
- Support business development efforts by performing appropriate due diligence on new opportunities, drafting and reviewing transaction documents and assisting in negotiations, as needed.
- Act as trusted advisor on legal issues to all levels of the company, including senior executives.
Knowledge, Skills & Abilities
- High integrity and high performance generally.
- Genuine interest in all aspects of the pharmaceutical and biotechnology industry.
- Excellent written, oral and interpersonal skills, including the ability to interface with, and gain the respect of, stakeholders at all levels and functions of the Company.
- Ability to function independently; work proactively as well as collaboratively and cross-functionally, and have excellent (internal) client interface skills.
- Ability to find appropriate balance between legal risks and the need of the business.
- Excellent critical thinking skills and ability to analyze and understand complex situations.
- Problem solver oriented towards finding practical solutions and providing practical
- Project management experience, ability to multi-task and prioritize frequently changing needs.
- The Corporate Counsel is expected to operate within the framework of Tolmars Core Values:
- Consistently operate with the highest standards of ethics and compliance.
- Take ownership of your actions, success and setbacks.
- Respect each other and understand that honest collaboration is at the heart of our company success.
- Go the extra mile to make things happen.
- Be committed to all we do and the patients we serve.
- Embrace change with enthusiasm.
- Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.
Education & Experience
- Juris Doctorate (J.D.) degree from an ABA accredited law school.
- Bar membership in Colorado or bar membership in another state, with ability to gain Colorado accreditation quickly.
- Five or more years experience in US law practice. Ideally experience working at a national or regional law firm or as in-house attorney at a brand pharmaceutical company.
- Significant knowledge of pharmaceutical industry and rules and regulations related to development, distribution, sale and marketing of pharmaceutical products (e.g., compliance with FDA marketing, advertising and labeling regulations) and laws related to fraud abuse and prevention (Anti-Kickback and False Claims Act) essential.