Manager, Legal Operations & Compliance

Company Overview:

Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc., is a biopharmaceutical company focused on developing innovative solutions for patients and healthcare providers in the fields of Critical Care and Infectious Diseases.

Our mission to deliver innovative, life-saving medicines for serious unmet medical conditions drives us every day and contributes to building a sustainable business for the long term. It also inspires our entrepreneurial culture which fosters innovation, collaboration, and a relentless commitment to the people we serve. Patients are at the center of everything we do because everyday matters. Every employee is encouraged to take initiative, explore new ideas, and turn challenges into opportunities that can potentially transform lives, especially those suffering from serious and difficult-to-treat illnesses.

Our products marketed in the U.S. include:

• GIAPREZA (angiotensin II) is a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock.
• XACDURO (sulbactam for injection; durlobactam for injection) is a new treatment designed specifically to treat hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex in adults.
• XERAVA (eravacycline) is a broad-spectrum antibiotic used to treat patients with complicated intra-abdominal infections (cIAI).
• ZEVTERA (ceftobiprole) is an approved advanced-generation cephalosporin antibiotic and the only FDA-approved cephalosporin specifically designed to treat adult patients with Staphylococcus aureus bloodstream infections (bacteremia) including those with right-sided infective endocarditis. In addition, Zevtera is approved in adult patients with acute bacterial skin and skin structure infections (ABSSSI), and adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP).
• Nuzolvence (zoliflodacin) for oral suspension is a first-in-class, single-dose oral antibiotic for the treatment of uncomplicated urogenital gonorrhea in adults and adolescents 12 years of age and older weighing at least 35 kg.

Position Overview:

The Manager, Legal Operations & Compliance will serve as a critical business partner to the Legal, Compliance, Finance, Procurement, and cross-functional teams, supporting the efficient operation of Innoviva's legal and compliance functions. This role will oversee contract lifecycle management, legal operations, compliance administration, entity management, and process optimization while driving scalability, governance, and operational excellence across the organization. The ideal candidate will bring experience in legal operations, contract management systems, procurement workflows, and compliance processes within a highly regulated life sciences environment.The role will closely collaborate with members of the Legal and Compliance teams to effectively coordinate projects, maintain records and systems, and manage streamline and improve internal processes

Duties and Responsibilities:

• Serve as the primary point of contact for legal contract intake, review coordination, and workflow management.

• Manage the end-to-end contract lifecycle, including intake, tracking, approvals, execution, renewals, amendments, and expirations.

• Own and administer legal contract management tools, databases, trackers, and document repositories.

• Maintain and continuously improve contract templates, clause libraries, standard operating procedures, and legal playbooks.

• Draft and review routine agreements utilizing approved templates, including NDAs, CDAs, Consulting Agreements, MSAs, and Statements of Work.

• Provide regular reporting on contract metrics, upcoming renewals, obligations, and business risks.

• Partner closely with Finance, Procurement, and IT to support contract-to-procure workflows and operational efficiency.

• Act as the Legal business lead for Coupa

• Licensing

• Manage state pharmacy licensing requirements, including securing and updating state licenses as needed.

• Manage Legal entity registrations

• Legal Entity Management

• Manage and maintain director and officer slates for all legal entities.

• Compliance Support:

• Support federal and state transparency reporting activities, including Open Payments and related transfer-of-value reporting requirements.

• Coordinate compliance-related documentation, approvals, and reporting activities supporting interactions with healthcare professionals and organizations.

• Assist with compliance monitoring, audits, documentation, and training initiatives.

• Serve as a key operational resource for sponsorship, grants, educational funding, and HCP engagement review processes.

• Support the data collection and submission process for Federal (Open Payments) and State-level transfer of value reporting; provide ad-hoc support for OUS (Outside US) transparency requirements as needed.

• Coordinate government price reporting and sales representatives' registrations and act as point person for required reporting with support from contracted vendors

• Act as a primary reviewer for funding and engagement requests, which could include Exhibit Requests, Sponsorships, and HCP Engagements

Education & Experience:

• Bachelor's degree required; Paralegal Certificate, Legal Studies, Business Administration, or related field preferred.
• 5+ years of experience in legal operations, corporate paralegal, contract management, compliance operations, or related roles within biotechnology, pharmaceutical, healthcare, or other regulated industries.
• Experience managing contract lifecycle processes and contract management systems.
• Hands-on experience with Coupa, procurement platforms, vendor onboarding, requisition management, or procure-to-pay workflows strongly preferred.
• Experience supporting corporate governance, legal entity management, licensing, or compliance programs preferred
• Notary Public certification is a plus.

Skills and Abilities:

• Proficiency with Microsoft Office suite, including Word, Excel and PowerPoint
• Highly organized and detail-oriented with strong task management skills
• Strong communication skills (both oral and written) with an ability to communicate legal issues in a clear and understandable manner
• Ability to build relationships across functions and sites and inspires trust and confidence through effective communication and interpersonal skills
• Ability to work independently and prioritize tasks/projects and meet deadlines in a fast-paced and dynamic environment
• A strong sense of professionalism and discretion in handling confidential information
• Enthusiastic and open to learning new subject matters
• Strong work ethic and ability to manage large workload, focus on critical priorities, and otherwise effectively meet internal legal needs and deadlines directly
• Excellent analytical and problem-solving skills
• Enthusiasm and self-starter qualities, and ability to manage responsibilities with an appropriate sense of urgency.

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, Inc. ("IST") is an equal opportunity employer that is committed to diversity and inclusion in the workplace. IST prohibits discrimination and harassment of any kind