$100K — $150K *
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Provide legal support for the Sales, Marketing, Commercial Operations, and Medical Affairs functions, in the furtherance of their operational responsibilities and consistent with the requirements of the Company’s Healthcare Compliance Program.
• Participate in multifunctional committee reviews of promotional and medical materials and in oversight of commercialization activities.
• Ongoing tracking and evaluation of legal and regulatory developments at the Federal and state levels pertinent to the commercialization of innovative pharmaceuticals, including but not limited to guidance and advisories from FDA, OIG, DOJ, and other relevant government agencies.
• Review contracts in support of the Commercial and Medical Affairs departments, including consulting agreements, speaker agreements, advisory board agreements, and certain vendor services agreements.
• In collaboration with the Healthcare Compliance function, and taking into consideration input from operational clients and colleagues, maintain and modify Company policies in a risk-based manner, as necessary to reflect changes and clarifications to applicable laws and regulations, develop associated written guidance, and conduct live or web-based training to operational teams.
• Assist Healthcare Compliance with the monitoring and auditing of Commercial and Medical Affairs activities, including periodic field-based monitoring activities.
• Participate in the investigation of complaints and alleged violations of rules, regulations, policies, procedures, and standards of conduct and coordinates with management in developing/implementing corrective action plans and provides general guidance on such matters.
• Handle miscellaneous legal tasks on an as needed basis under direction of senior attorneys.
• May directly or indirectly supervise employees, consultants and/or vendors.
• BS/BA degree, preferably in life sciences or a related field.
• JD degree required and must be admitted to practice, preferably in California.
• Four to six years of experience as an attorney in a law firm or in-house legal environment, with a focus on providing regulatory and/or litigation support for marketed products in the biotechnology or pharmaceuticals industry.
• Excellent interpersonal skills with the ability to articulate legal advice in a clear, concise and complete manner, both verbally and in writing.
• As a visible representative of the Legal department with responsibility for the enforcement of Company polices and ethical standards, must exercise strong, positive leadership and influencing skills.
• Must have a record of professional performance and personal integrity reflective of good judgment and the ability to apply legal principles to business facts in a reasonable manner.
• Must be detail-oriented and have strong organizational skills.
• Ability to handle multiple tasks simultaneously and with the ability to re-prioritize on short time frames.
• Acts responsibly and conscientiously.
• Works under pressure to meet specific deadlines.
• Works independently and in a cross-functional team environment.
• Dedicated to quality, reliability, and highest professional standards in all work tasks.
• Must be a self-starter and quick learner.
• Requires strong computer skills.
Valid through: 10/21/2020