Compliance Corporate Counsel

Company Overview:

Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc., is a biopharmaceutical company developing and delivering innovative therapies in critical care and infectious disease. Our approved treatments are indicated to address high unmet medical needs for serious conditions, and our investigational therapies are in development for patients fighting drug-resistant pathogens. Innoviva currently has three marketed medicines - GIAPREZA (angiotensin II) for the treatment of refractory hypotension in adults with septic or other distributive shock , XERAVA (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI), and XACDURO (sulbactam for injection; durlobactam for injection), a new treatment for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex. Our investigational therapy, Zoliflodacin is a potential first-in-class, orally administered, single dose antibiotic with a novel mechanism of action that is currently in development for the treatment of uncomplicated gonorrhea. At Innoviva Specialty Therapeutics, Inc., we are building a culture dedicated to delivering products that address critical medical needs. If this is your passion, come and join us to make differences for patients.

Summary of Position:

The Compliance Corporate Counsel role reports to the Sr. Corporate Counsel. As a senior member of the Legal team, a highly visible representative for the team, the Compliance Corporate Counsel will lead Innoviva Specialty Therapeutics, Inc. (the "Company") Compliance Program and is responsible for:

• The overall strategic direction of the Compliance Program by providing strategic advice to the business to ensure compliance with (i) applicable laws, including but not limited to federal and state antikickback and false claims laws, the federal Food Drug and Cosmetic Act (FDCA) laws, federal and state transparency laws and the PhRMA Code and (ii) Company policies/procedures.
• Leading and deploying continuous improvement for an effective Company Compliance Program, including ensuring the Company meets requirements for the elements of an effective compliance program as defined by the OIG
• Educating all employees on the Compliance Program, its strategic importance to the business and its relationship to Company values and goals
• Managing healthcare compliance materials, policies and procedures, training, auditing, monitoring, risk-assessing, investigating, and reporting.
• Championing a proactive approach to ensuring compliance with laws and regulations specific to the pharmaceutical/biotech industry with a focus on partnership, prevention, detection, and risk mitigation.
• Serving as the legal/compliance reviewer for Company materials, publications, exhibit requests, policies, procedures and SOPs
• Serving as the legal representative for cross-functional Company committees
• Drafting, reviewing and negotiating all agreements for medical and regulatory stakeholders, including agreements related to clinical studies and investigator- initiated research

Responsibilities:

Further to the main objectives set forth above, the Compliance Corporate Counsel shall effectively manage the following responsibilities:

Company Compliance Program

• Lead Company Compliance Program - continue to grow, mature and refine it in accordance with developing industry guidance and trends, as well as the particular business needs and risks of Company
• Strategic legal and compliance partner - provide strategic advice to the business to ensure compliance with applicable US laws and Company policies, including federal and state antikickback and false claims laws, the federal Food Drug and Cosmetic Act (FDCA) laws, federal and state transparency laws (e.g. Open Payments and State Drug Transparency), the PhRMA Code, state laws, etc.
• Periodically report to the Executive Leadership Team on matters relating to the management and oversight of the Company Compliance Program
• Review business strategy plans for compliance risks and advise the business on how to mitigate those risks
• Develop and maintain trusting relationships with sales and other field personnel; serve as a trusted advisor and resource
• Keep legal and Company stakeholders informed of recent developments relating to laws, regulations, and industry trends affecting the Company.
• Act as compliance champion to reinforce a culture of integrity and raise awareness of compliance as a collective responsibility of all Company personnel through effective engagement, training, auditing and monitoring.
• Support the Head of Legal in compliance and healthcare law matters as well as administrative matters

Review of Company Materials

• Serve as the legal/compliance representative on the Company's various committees:
• Medical, Legal and Regulatory ("MLR") Review Committee and review promotional materials, prior to approval for use
• Nonpromotional Material Review Committee and review/approve nonpromotional materials, prior to use
• Grant Review Committee and review/approve grants
• Research Review Committee and review/approve research endeavors
• Publication Committee and review/approve Company-collaborated and external publications
• Review/approve Company exhibit and sponsorship Requests

Company Policies and Procedures

• Draft compliance policies, procedures, and guidance to ensure consistent application of the Company compliance program and to ensure compliance with applicable laws and regulations
• Collaborate with internal stakeholders and assist with the drafting of Company policies/procedures and guidance
• Serve as the legal/compliance representative to review/approve Company GXP SOPs

Compliance Training

• Develop compliance and legal training curriculum and conduct training at sales meetings and other Company meetings on compliance policies and legal and compliance matters
• Develop and implement new hire compliance training
• Prepare training materials to educate both commercial and corporate employees and conduct such compliance related trainings
• Implement a routine compliance training schedule and ensure Company employees attend and complete all necessary compliance trainings
• Develop and ensure communication across the Company in compliance matters

Compliance Risk Assessments

• Develop and implement a strategic and practical enterprise risk assessment framework and related processes that are aimed to identify risk areas for the Company
• Lead the enterprise risk assessment efforts for the Company, including identifying potential gaps, reporting findings to senior management, and proposing appropriate remediation activities
• Develop mitigation plans, as needed, to address risks identified under Company enterprise risk assessment in coordination with Company Leadership

Compliance Monitoring

• Stay connected across the business in a monitoring role to identify and proactively address compliance issues
• Create a routine Compliance Monitoring Program for the Company and methods to monitor compliance with business practices, policies, laws, and regulations
• Conduct compliance monitoring activities (e.g., documentation reviews of travel & field expenses; field rides; speaker programs) to ensure compliance with laws, regulations and industry standards, including state and federal anti-kickback statutes, FDA and other relevant regulatory requirements, and applicable corporate codes and policies
• Track remediation for all activities

Compliance Investigations

• Conduct compliance investigations as required, both internally and with the assistance of outside counsel and manage the compliance reporting hotline
• Collaborate with internal stakeholders to ensure the effective investigations into alleged violations of law, regulation, and Company requirements including identifying appropriate corrective actions as needed
• Manage and conduct compliance investigations into alleged violations of the compliance program working with internal business partners to identify appropriate corrective actions as needed
• Manage and continuously improve the compliance monitoring and investigation processes

Pricing and Transparency

• Facilitate and ensure Company meets all applicable transparency requirements including the Physician Payments Sunshine Act, required state attestations, and required state drug transparency requirements including collaborating with internal stakeholders and external vendors, to prepare, review, and submit reports
• Support government pricing by providing strategic advice to the business in order to ensure compliance with federal and state government pricing laws
• Serve on the Pricing Committee, a committee that approves drug price increases, discounts, and rebates

Company Agreements

• Execute all study agreements for Company to include all clinical trial agreements and investigator-initiated research and serve as legal/compliance contact for all clinical studies
• Collaborate with cross-functional teams concerning compliance and regulatory issues that relate to a broad range of complex agreements, including agreements for investigator initiated research, research collaboration, sponsored research, clinical trials, expanded access, compassionate use, patient recruitment, informed consents, sponsorships and exhibits, grants, advisory boards, data sharing and data licensing, investigator-initiated trials, scientific presentations, company communications (internal and external) and regulatory, quality, and pharmacovigilance agreements

Other Responsibilities

• Coordinate with Sr. Corporate Counsel to draft annual budgets and ensure budget requirements are achieved
• Manage the Company's Fair Market Value ("FMV") assessments of Healthcare Professionals
• Manage the Company's Conflict of Interest Disclosure Process in collaboration with Human Resources
• Conduct compliance related research and report research findings upon request
• Serve as the Company's privacy delegate and collaborate with the Head of IT on privacy/security matters
• Participate in relevant industry associations and compliance benchmarking groups
• Other duties as assigned

Experience & Education:

• Juris Doctor degree is required
• Certifications (e.g., Compliance, Auditing, etc.) are a plus
• 10 plus years of experience in corporate and healthcare compliance for a healthcare company
• Profound knowledge of U.S. compliance regulations, laws, and standards
• Strong business acumen across the pharmaceutical/biotech functions (e.g., Commercial, Medical Affairs, Legal)
• Experience in the design and implementation of a healthcare compliance program
• Strong experience in the following areas:
  • Pharmaceutical specific laws and regulations including, but not limited to, Food, Drug and Cosmetics Act (FDCA), Federal Anti-kickback Statute, Federal False Claims Act, U.S. Sunshine Act and state transparency laws, drug transparency laws, and the PhRMA Code
  • Conducting healthcare compliance risk assessments and compliance audits
  • Managing and preventing healthcare compliance risk
  • Conducting healthcare and commercial compliance monitoring (e.g., documentation reviews, field rides, speaker programs, etc.)
  • Leading and managing internal compliance investigations
  • Leading continuous improvement efforts for compliance programs
  • Creating and presenting presentations for mid-level and senior-level management
  • Drafting and negotiating a range of agreements
  • Serving as legal reviewer of materials for pharmaceutical companies

Skills and Abilities:

• Ability to cultivate strong stakeholder relationships and communicate complex concepts in ways that are understood and actionable by cross-functional teams (i.e. translate complex requirements into practical suggestions and real-world solutions)
• Strong management skills.
• Excellent communication skills, both verbal and written
• Highly organized with a strong attention to detail, clarity, accuracy, and conciseness and ability to identify business, legal and compliance issues
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook) and Veeva PromoMats
• Excellent analytical and problem-solving skills and the ability to manage ambiguous situations and issues
• Enthusiasm and self-starter qualities, and ability to manage responsibilities with an appropriate sense of urgency
• Self-motivated and able to perform role independently, with a minimum level of supervision
• Ability to function effectively and efficiently in a fast-paced and dynamic environment
• Possess a "roll your sleeves up" mentality with a desire to further build the Compliance Program
• Business focused and solution oriented
• Strong organizational and project management skills with an ability to work in a fast-paced, innovative and collaborative environment.

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Innoviva Specialty Therapeutics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.