Global Director, Regulatory Compliance
Posted on Apr 6, 2021 by Eversana
ESSENTIAL DUTIES & RESPONSIBILITIES:
Build & Improve the Companys Regulatory Compliance Program
Develop and implement compliance systems and procedures for all service lines
Develop and implement internal training procedures with respect to those compliance systems and procedures
Provide ongoing and regular counsel in support of outsourcing activities, including marketing and sales efforts, HCP interactions, patient advocacy group interactions, and other relevant activities and initiatives
Provide necessary legal support for the Sunshine Act, False Claims Act, Kickback Statue, OIG guidance, PhRMA code, and state-by-state pharmacy laws
Provide support and serve as the principal point of contact for interactions with regulatory bodies including but not exclusive to State Boards of Pharmacy, FDA, HHS, DOJ, and DOL
Review of outward facing communications with regulatory implications
Keep informed of new laws, regulations and industry trends affecting the company, and assist with development of policies and training as needed.
Secure and maintain the buy-in and support of leadership and management at all levels of the company in respect of the compliance standards required by the groups and its shareholders.
Develop the existing compliance environment to balance the risk of violation with the administrative burden on the operational organization.
Ensure compliance training and education is available to, and completed by the employees of the company including, but not limited to, delivering training sessions, self-service information resources and Computer Based Training.
Manage all compliance inquiries and potential violations reported through the established helpline and whistle-blower services.
Manage all Governance issues of the Compliance environment globally.
Maintain and revise policies and procedures for the general operation of the Compliance Program and its related activities to prevent illegal, unethical, or improper conduct. Manages day-to-day operation of the Program.
Develop and periodically review and update The Code of Conduct to ensure continuing currency and relevance in providing guidance to management and employees.
Collaborates with other departments (eg, Quality, Internal Audit, Human Resources, Legal, etc.) to direct compliance issues to appropriate existing channels for investigation and resolution. Consults with the legal department as needed to resolve difficult legal compliance issues.
Respond to alleged violations of rules, regulations, policies, procedures, and Code of Conduct by evaluating or recommending the initiation of investigative procedures. Develops and oversees a system for uniform handling of such violations.
Identify potential areas of compliance vulnerability and risk and conduct annual risk assessments
Provide reports on a regular basis, and as directed or requested, to keep senior management informed of the operation and progress of compliance efforts.
Ensure proper reporting of violations or potential violations to duly authorized enforcement agencies as appropriate and/or required.
Establish and provide direction and management of the compliance Hotline.
Institute and maintain an effective compliance communication program for the organization, including promoting (a) use of the Compliance Hotline; (b) heightened awareness of the Code of Conduct, and (c) understanding of new and existing compliance issues and related policies and procedures.
Work with business teams and senior management to ensure awareness of "best practices" on privacy and data security issues
Collaborate on cyber privacy and security policies and procedures
Interface with Senior Management to develop strategic plans for the collection, use and sharing of information in a manner that maximizes its value while complying with applicable privacy regulations
Assist business units with development of tools and methodologies to ensure ongoing compliance
Provide strategic guidance to corporate officers regarding information resources and technology
Assist the Chief Information Officer with the development and implementation of an information infrastructure
Act as a liaison to the information technology department
Collaborate with the legal department on privacy issues relating to business partner contracts and product-related activities
Develop a process for receiving, documenting, tracking, investigating and taking action on all privacy related complaints
Develop, implement and train on the Companys Incident Response Plan
Mitigate effects of a use or disclosure of personal information by employees or business partners by ensuring the implementation of an incident response plan
Administer action on all complaints concerning the organizations privacy policies and procedures in coordination and collaboration with the Compliance Investigation Team and when necessary, legal counsel
Experience and Required Skills
10+ years Compliance experience
D. from accredited law school preferred
Comprehensive knowledge and understanding of the relevant legal, regulatory and compliance issues and their practical application
Health law expertise (FDA regulations and guidance's; federal and state kickback laws; the prohibition against off-label promotion; FCPA; False Claims Act) to advise the company
Knowledge of the managed markets/payer industry, such as PBMs, rebate agreements, specialty pharmacies and related payer groups, as well as Medicare.
Knowledge of US and EU privacy laws related to the pharmaceutical and clinical research industry
Experience with building and implementing a privacy program
Extensive experience and skill at writing policies and guidance documents supporting various business activities and conducting investigations.
Ability to write clearly and prepare professional communications
Experience working with teams across full corporate structure
Excellent interpersonal and conflict resolution skills and ability to work in a highly collaborative, team-oriented environment
High level of influencing skills and ability to drive change as it relates to implementing remedial actions
Prior in-house experience preferred