Definium Therapeutics

Director, Commercial and Medical Legal Counsel

Definium Therapeutics

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $217,877 - $260,733 per year

Job Level

Lead

About the role

  • Provide day-to-day legal counsel to Sales, Marketing, Market Access, Medical Affairs, HEOR and Patient Advocacy teams, advising on a broad range of regulatory matters, including labeling discussions, advertising and promotion, drug safety, market research, scientific exchange, and interactions with healthcare professionals and patients
  • Participate as a core member of promotional and medical MLR Review Committees, and advise on advertising, promotion, and scientific exchange
  • Advise on interactions with healthcare professionals, payers, patients, and patient advocacy organizations, and help identify and mitigate compliance risks
  • Review and/or draft contracts for compliance with relevant regulatory standards
  • Ensure compliance with all relevant laws, regulations, policies, procedure and controls within relevant business areas supported
  • Develop and deliver training for business partners on legal and compliance issues
  • Communicate legal advice to business stakeholders in an authentic and understandable way

Requirements

  • Juris Doctorate and admission to practice law in at least one state
  • Minimum 5 years legal experience, including experience advising pharmaceutical or other life sciences clients is required. In-house pharmaceutical industry experience is preferred
  • Understanding of applicable laws and regulations, particularly FDA promotional guidance, the Anti-Kickback Statute and False Claims Act, the PhRMA Code, and relevant HHS-OIG guidance
  • Strong interpersonal skills and ability to present complex information accurately and concisely to influence others at all levels of management
  • Experience with state price reporting, transparency reporting or privacy matters preferred
  • Ability to provide clear, actionable guidance in a fast-paced environment and handle multiple, conflicting priorities and time-sensitive situations
  • High degree of professional ethics and integrity
Benefits
  • 100% paid health benefits including Medical, Dental and Vision for you and your dependents
  • 401(k) program with company match and vesting after the turn of the first month after your start date
  • Flexible time off
  • Generous parental leave and some fun fringe perks!
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Juris Doctoratelegal counselcontract reviewregulatory complianceadvertising and promotiondrug safetymarket researchscientific exchangetraining developmentlegal advice communication
Soft Skills
interpersonal skillspresentation skillsinfluencing skillsclear communicationactionable guidancetime managementethical judgmentintegrityproblem-solvingadaptability
Certifications
admission to practice law