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Senior Counsel - COMPLIANCE

Vaxxinity

Posted May 06

Full TimeRemoteRemote

Job Description

Senior Counsel - COMPLIANCE

Location: Remote within USA (NY, CA, CO, TX or FL preferred), Mexico City or Toronto

Experience: 6-12 years

Type: Full-time Exempt

Reports to: General Counsel

Vaxxinity is a clinical-stage immunotherapeutic company recently formed through the combination of COVAXX and United Neuroscience, two independent companies affiliated with United Biomedical. Led by a female CEO, in an informal values-driven start-up culture, Vaxxinity controls development candidates targeting neurologic disorders, hypercholesterolemia and COVID-19. Vaxxinity is currently pre-selling and ramping up production and distribution for hundreds of millions of COVID-19 vaccines.

Vaxxinity is an international company, operating remotely from across several countries. You will collaborate with a group of inspiring colleagues all over the globe who are working on disruptive projects, solving big problems and having a huge impact. Expect to grow, expect to be challenged, and expect the unexpected as we embark on this journey of democratizing health for all the world’s citizens.

Role

The Compliance Senior Counsel is responsible for advising the entire organization regarding U.S. and international compliance topics and providing legal counsel to a broad range of internal clients. Specifically, the Counsel will advise on issues related to risk mitigation, legal and regulatory considerations in the commercialization, sales, promotion and support of marketed products as well as the conduct of clinical trials, and will be responsible for developing compliance strategies, infrastructure, policies, procedures and training. Will translate legal requirements into succinct and meaningful operational principles to advance the mission and business objectives. The Counsel will work directly with the General Counsel in the development and maturation of the company’s legal operations.

Responsibilities

(duties are not limited to the below and may evolve over time depending on business needs and individual expertise)

Analyze whether diverse business practices across the company comply with U.S. regulations and international standards, including the FCPA and UK Bribery Act
Integrate global compliance standards into internal policies and process descriptions
Present, explain and train on compliance obligations and processes to internal stakeholders and third parties, including customer and supplier representatives
Provide legal guidance and support to compliance processes including third party compliance screenings and compliance risk assessments
Continuously monitor compliance standards and legal developments
Provide effective legal support for matters regarding the research, development and commercialization of products and product candidates.
Provide advice, guidance and counsel to the sales, business development and related functions on commercial and product strategies, programs, policies, practices and initiatives.
Support and advise the General Counsel on the design, execution and maintenance of a robust compliance program, including compliance policies, procedures, and risk assessments. Collaborates with all departments to develop plans to improve compliance and governance infrastructure.
Define risks and clearly communicate and explain those risks to appropriate internal decision-makers for discussion and resolution.
Coordinate with senior leadership for each operational group with respect to legal support to meet corporate priorities. Interacts with various internal clients and functional groups to effectively address legal and business questions and provide guidance as well as practical solutions.
Advise on privacy and related legal regimes, such as HIPAA, data privacy and security issues and on complex business issues and compliance matters.
Draft, review, revise and negotiate a variety of agreements for the Company and advise on interpretation of existing agreements.
Review and assist with the preparation of responses to communications from regulatory authorities.
Provide counsel and support when necessary to any internal investigations, contract disputes, or other legal matters. Supports any litigation that arises.
Provides additional support to the General Counsel on other matters and assume other responsibilities.

Education / Experience

Juris Doctorate from an ABA-accredited law school
6 to 12 years of relevant legal experience
License to practice as an attorney in at least one US jurisdiction.
Biotech / Commercial Stage Pharma

Knowledge / Skills / Abilities

Fluent in more than one language. Business is conducted in multiple languages. Spanish or Mandarin are a big plus.
Strong knowledge and understanding of healthcare laws, guidance documents, and industry codes relating to the discovery, development and commercialization of biopharmaceutical products, including FDCA, FDA guidance Documents, Fraud and Abuse laws, Anti-kickback Statutes, federal and state transparency laws, etc.
Must be able to manage conflicting priorities in fast-paced environment, and work independently on a wide range of issues and projects, while delivering high-quality work under a tight timeline
Proven ability to develop and implement legal strategies that support business and financial objectives
High energy level and high degree of self-motivation, with a sense of urgency to achieve stated business goals
Demonstrate ability to think creatively and devise solutions to challenging problems
Sound judgment and commitment to ethical conduct, extreme attention to detail
Excellent communication skills in a wide array of situational settings from c-level interaction to core team members, imparting both vision and execution focus; deep analytical skills.
A strong team player who supports their team and embraces ownership, accountability, and responsibility for the team’s work.
Ability to influence decision making with or without authority, facilitate groups with diverse perspectives, across geographies, and bring teams to agreement.
Strong interpersonal skills that build productive relationships and influence others across the company.
Ability to give what it takes: demanding hours, with scheduling flexibility, with a start-up attitude of intense dedication.
Humility and the belief you can make the world a better place.