Director, Compliance

New Yesterday

Job Summary:
The Director will be a key interface to the Aquestive business and support the Company's efforts in identifying, establishing, maintaining and reviewing compliance risk controls and compliance strategy throughout the organization. The individual will report to the VP, Global Quality and Compliance and will serve as a leader and subject matter expert to drive the development and implementation of policies, procedures, processes, and training in accordance with applicable laws, regulations, guidelines, and codes.
Responsibilities: Work with management to promote a culture of compliance awareness and ethics throughout the organization Review organizational operations to develop, direct, execute and communicate the Company's compliance strategy Advise and develop work plans, facilitating annual compliance reviews, responding to compliance queries and reports and work with the Human Resources on internal and external investigations related to reactive and proactive compliance or personnel issue Oversee and ensure follow-up and/or corrective action plans to compliance issues identified Partner with Commercial, Medical, Legal, and other functions as needed to develop and implement standards, policies, procedures, and processes that effectively manage compliance risk Oversee transparency reporting and adherence to Company policies associated with payments to healthcare providers Work with management to establish the development of specialized compliance training programs, curricula and tracking, and reporting via the Company's learning management system Provide leadership and direction to business partners, advising on activities and programs to help ensure alignment with Company compliance policies and procedures Interact with regulatory agencies, internal and external advisors, and other internal control groups on compliance in order to determine specific needs and procedures Have knowledge of and monitor and identify emerging issues, developments in industry practices and standards and compliance risk trends and in relevant laws and regulations, including FDA, OIG, DOJ, Sunshine Act (Open Payments), and anti-kickback statutes Collaborate with other functions to develop, implement and establish continuous improvement of an effective compliance program Develop and deliver compliance reports to leadership teams and appropriate committees Represent Legal in MLR review of promotional materials, scientific communications, and engagement activities to ensure that regulatory, legal, and compliance standards are met Assist in executing compliance monitoring activities Assist in conducting investigations of potential compliance issues Perform other compliance projects, activities and initiatives, as needed Qualifications: BS/BA degree required; Juris Doctorate degree (strongly preferred) 10+ years of compliance expertise in the pharmaceutical industry Experience serving on MLR review committees, with demonstrated ability to assess promotional content for compliance with regulatory and legal requirements Knowledge of the laws, regulations, guidelines, and codes impacting the industry, and their application to a commercial business Knowledge of laws, regulations and codes related to government price reporting and DEA compliance Strong influencing skills and demonstrated ability to communicate effectively and present ideas and solutions to all levels of the organization Strong planning and organization skills with the ability to lead and manage multiple projects concurrently Must be self-motivated and possess strong interpersonal skills 10-15% travel is required
The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.
As part of Aquestive's employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place.
Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected Base salary range: $160,000 to $200,000 USD
Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
Location:
Warren, NJ, United States
Category:
Management Occupations

We found some similar jobs based on your search