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Associate Director, Compliance

Company: G1 Therapeutics, Inc
Location: Raleigh
Posted on: February 22, 2021

Job Description:

G1 Therapeutics is a clinical-stage biopharmaceutical company focused on discovery, development, and delivery of next generation therapies that improve the lives of those affected by cancer. The company is developing and advancing two novel therapies. Trilaciclib --is a first-in-class investigational therapy designed to improve outcomes for people with cancer who are treated with chemotherapy.--A New Drug Application (NDA) for trilaciclib has been assigned Priority Review by the FDA, with an action date of February 15, 2021. G1 is also advancing-- rintodestrant , a potential best-in-class oral selective estrogen receptor degrader, or SERD, for the treatment of ER+ breast cancer. In 2020, G1 out-licensed global development and commercialization rights to its differentiated oral CDK4/6 inhibitor,-- lerociclib . The Opportunity: G1 Therapeutics is currently recruiting an Associate Director, Compliance--to join our team in Raleigh, NC, reporting to the VP of Commercial Counsel. In this role you will--support the development and implementation of the Company's ethics and compliance program. Key responsibilities include implementation and ongoing management of program initiatives pertaining to interactions with healthcare professionals such as FMV management, support for Medical Affairs and Commercial programs such as ad boards and speaker programs, aggregate spend and transparency reporting. Additionally, the role will contribute to building maintaining and executing all elements of an effective corporate and commercial compliance program.-- Responsibilities:

  • Provide support for cross functional compliance-related functions, particularly in Commercial and Med Affairs, and building the Company's Commercial and Med Affairs compliance program
    • Manage Company HCP Interactions including FMV operations (e.g. tiering, documentation and process management for Speaker Programs, Ad Boards, Market Access programs)
    • Compliance operations support with external co-promote partner
    • Support Compliance, Med Affairs and Commercial committees such as Corp Compliance Committee, CME, ISS and Pricing committees
    • Responsible for Federal and State aggregate spend reporting strategy and systems, compliance initiatives and operational effectiveness
      • Implement aggregate spend system, work with internal departments and external vendors as needed to achieve smooth integration into company operations
      • Work collaboratively and manage the collection of required information and data for state and federal reporting purposes by working with Finance, Commercial Operations, Med Affairs, Clinical Development, Marketing, 3rd party vendors and other transparency feeds
      • Manage and deliver communication and training on progress, implementation and ongoing needs of transparency reporting
      • Manage the preparation of state and federal reports in accordance with applicable laws
      • Provide guidance and direction to achieve compliance with all US compliance reporting and transparency laws; serve as a subject matter expert on federal and state laws and requirements
      • Ensure accurate and completeness of spend collection as needed
      • Support price reporting as needed
      • Ad hoc related duties as assigned
      • Assist with developing and implementing policies, procedures, training, monitoring, and auditing practices as part of an overall compliance program
      • Approach compliance with creative and operational perspectives
      • Strive to continually advance knowledge of business ethics and compliance Requirements:
        • Bachelor's Degree and at least 6 years of experience in life sciences industry
        • Minimum of 4 years life science compliance experience preferred, ideally within or working closely with a pharmaceutical or medical device company
        • Experience in life science commercialization preferred
        • Knowledge of standard life science applications such as expense reporting and CRMs strongly preferred
        • Previous audit or finance experience is a plus
        • Desire to contribute to growing business; approaches work with passion, integrity, drive and effectiveness
        • Demonstrated record of integrity, intelligence, enthusiasm and attention to detail
        • Demonstrated ability to work both independently and collaboratively and accomplish project goals
        • Demonstrated creative thinking; sense of humor strongly preferred
        • Strong interpersonal skills to interact with employees of all organizational levels
        • Motivated self-starter; strong organizational skills; eager to learn and grow in role
        • Ability to work in a fast-paced, driven environment
        • Must be able to handle highly sensitive and confidential information (dependable discretion)
        • Outstanding verbal and writing skills
        • Proficient in MS Word, Excel and PowerPoint
        • Occasional overnight travel may be required; no more than 20% (when safe and appropriate*) Why Join Us? We know our employees are our most valuable asset, and our culture conveys that. All employees are issued laptops, and our office staff all have height-adjustable desks, access to a stocked kitchen, and multiple employee events throughout the year. We also offer a competitive benefits package, including generous PTO, to support the health and happiness of our staff. An Equal Opportunity Employer G1 Therapeutics is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at G1 Therapeutics are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Do you now, or will you in the future, require sponsorship (e.g., H-1B visa status, etc.) to work legally for G1 Therapeutics in the United States?* Do you have recent compliance experience in one or more Life Science companies?*

Keywords: G1 Therapeutics, Inc, Raleigh , Associate Director, Compliance, Executive , Raleigh, North Carolina

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