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Compliance Operations Manager

Company: SpringWorks Therapeutics
Location: Stamford
Posted on: September 24, 2022

Job Description:

About SpringWorks Therapeutics

SpringWorks Therapeutics is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing, and commercializing life-changing medicines for underserved patient populations suffering from devastating rare diseases and cancer. SpringWorks has a differentiated portfolio of small molecule targeted oncology product candidates and is advancing two potentially registrational clinical trials in rare tumor types, as well as several other programs addressing highly prevalent, genetically defined cancers. SpringWorks' strategic approach and operational excellence in clinical development have enabled it to rapidly advance its two lead product candidates into late-stage clinical trials while simultaneously entering into multiple shared-value partnerships with industry leaders to expand its portfolio.

This role will be reporting to the company's Compliance Officer, the Compliance Operations Manager will execute aspects of the operations of SpringWorks' global healthcare compliance & ethics program. The Compliance Operations Manager will work cross-functionally supporting the Compliance, Privacy, and Legal Team operations including processes and systems.

Your Essential Role & Responsibilities:

  • Support the Compliance function's operational objectives and various special projects with a goal of ensuring that SpringWorkers adhere to the highest legal and ethical standards in all business activities.
  • Help develop policies, procedures, and processes utilizing existing systems and new, innovative, tools and technology to further the company's mission and streamline operations
  • Create trainings, leveraging systems, and currently internal learning platforms.
  • Track and compile records of training using internal systems and centralized documentation. Provide regular training updates, status reports, and scorecards 'training metrics' for the Compliance, and Privacy organizations.
  • Help Support communication programs, and disclosure program awareness initiatives to enable all SpringWorkers to seek assistance, make suggestions, raise concerns or identify issues regarding compliance.
  • Support compliant interactions between field personnel, healthcare professionals (HCPs), and other customers through appropriate training and communication of policies, procedures and other requirements
  • Work at the direction of the Compliance & Privacy Leadership to ensure that all compliance concerns or reports of compliance violations as well as privacy matters are investigated and resolved or properly reported.
  • Assist in the management of compliance and legal operations mechanisms to meet the needs of the company as it prepares for commercialization, including without limitation, processes for debarment/exclusion screening, Sunshine Act reporting, state compliance reporting, privacy law compliance, FCPA/Anti-Bribery and fraud and abuse compliance, auditing / monitoring of healthcare participant-facing field roles, evaluating payments to HCPs against fair market value standards and oversight of the company's compliance hotline.
  • Assist with Legal Department operations as needed, including with various projects assigned by the Company's attorneys.
  • The position requires periodic travel for training, meetings, and field monitoring.
  • Project and system management
  • Vendor management from selection, onboarding, and regular engagement with vendor
    Your Education & Experience:

    Education:
    • Bachelor's degree.
      Experience:
      • 3+ years' experience in international / US healthcare compliance in the biopharmaceutical industry, including providing compliance advice or support, playing key roles in supporting compliance training to pharmaceutical/biotech companies including experience with learning management systems (LMS) and/or training technology.
      • Launch preparation and experience preferred
      • Knowledge of healthcare laws and regulations, including the False Claims Act, Anti-Kickback Statute, Sunshine Act, FCPA/UKBA, and privacy laws and regulations.
      • Understanding and hands on experience with policies, procedures and process for spend capture, transparency, and Sunshine Act.
      • Must possess a strong sense of ownership and responsibility, as well as a proven work ethic delivering excellent work product and exemplary customer service.
      • Demonstrates passion for the business and this role; espouses a collaborative approach; leads by example in setting a positive tone for the compliance function.
      • Ability to influence key stakeholders and drive decisions.
      • Must be able to present to and work effectively with a team.
      • Excellent communicator in both the written and oral form; understands how to approach communication from a strategic perspective.
      • Promotes ideas and new proposals persuasively; works through conflicts and difficult situations.
      • Cultivates internal relationships and relates well to key colleagues at all levels

        Are you a SpringWorker?

        How much do you care?
        How well do you partner with others?
        How fast do you move?
        Are you a problem solver?
        Are you comfortable challenging convention?

        At SpringWorks Therapeutics, we ignite the power of promising science to unleash new possibilities for patients. We work hard, we care even harder and we're in it together. We are looking for ambitious, smart, and hardworking colleagues to join our growing team.

        SpringWorks Therapeutics is an Equal Employment Opportunity employer. All qualified applicants/employees will receive consideration for employment without regard to that individual's age, race, color, religion or creed, national origin or ancestry, sex (including pregnancy), sexual orientation, gender, gender identity, physical or mental disability, veteran status, genetic information, ethnicity, citizenship, or any other characteristic protected by law.

        GDPR Statement: When you apply to a job on this site, the personal data contained in your application will be collected by SpringWorks Therapeutics ("Controller"), which is located at 100 Washington Blvd, Stamford CT 6902 and can be contacted by emailing hr@springworkstx.com . Your personal data will be processed for the purposes of managing Controller's recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.

        Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller's behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. Because the European Union Commission has determined that United States data privacy laws do not ensure an adequate level of protection for personal data collected from EU data subjects, the transfer will be subject to appropriate additional safeguards under the standard contractual clauses. You can obtain a copy of the standard contractual clauses by contacting us at hr@springworkstx.com.

        Your personal data will be retained by Controller for as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have to right to data portability. In addition, you may lodge a complaint with an EU supervisory authority.

Keywords: SpringWorks Therapeutics, Stamford , Compliance Operations Manager, Executive , Stamford, Connecticut

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