Job Description
- Provide direct legal support to the Market Access department, in the furtherance of their operational responsibilities and in a manner consistent with the requirements of the Company?s Healthcare Compliance Program.
- Draft, review and negotiate contracts in support of the Market Access department, including purchase and distribution agreements, GPO agreements, and PBM agreements; advise on government price reporting requirements as it relates to these agreements.
- Advise Market Access department on legal landscape for patient assistance programs, including free drug programs, free trial programs, co-pay assistance, and independent patient assistance foundations.
- Advise Commercial-Market Access department on patient assistance program messaging.
- Provide legal advice related to alternate funding programs, co-pay accumulators, and co-pay maximizers.
- 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, CMS, and other relevant government agencies.
- Advise and troubleshoot on existing agreements.
- In collaboration with the Healthcare Compliance function and taking into consideration input from operational clients and colleagues, maintain and modify Company policies and SOPs 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 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 a broad variety of miscellaneous legal tasks on an as needed basis.
- No supervisory responsibilities but may provide direction to other individuals.
- BS/BA degree; optimally in life sciences or a related field.
- JD degree required and must be admitted to practice, preferably in California.
- At least 6 years of experience as an attorney in a law firm or in-house legal department, with a focus on providing transactional and regulatory advice regarding marketed products in the biopharmaceutical or biotechnology industry.
- Contract drafting and negotiation experience required.
- Thorough knowledge of laws, regulations and guidance applicable to various biopharmaceutical commercial initiatives.
- Thorough knowledge of processes related to the drafting, negotiation and review of various commercial contracts.
- 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.
- Environment: primarily working indoors, performing clerical work
- This job will require travel 5% of the time.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.