Manager, Compliance Avanir Pharmaceuticals
The Manager Compliance, assists the Vice President, Chief Compliance Officer (CCO) in developing, implementing and maintaining an effective Corporate Compliance Program that:
Supports and promotes a company-wide culture of ethics and compliance
Ensures the company's compliance with all applicable federal and state health care laws and regulations, and industry codes of conduct
This position is primarily responsible for the administration and management of the companys transparency reporting program as well as data analytics associated with the compliance program. Additional responsibilities include development and implementation of compliance policies and communications as well as performing auditing and monitoring in support of the companys healthcare compliance program. As a member of a collaborative team, this position also will contribute to the development and implementation of other components of the compliance program.
DUTIES AND RESPONSIBILITIES
The primary duties and responsibilities of this position include the following:
Serves as a compliance subject matter expert on federal and state healthcare provider transparency laws and requirements, working with business owners across functions to ensure they understand their reporting obligations and that reports are filed with federal and state authorities in line with applicable laws:
Responsible for timely and accurate submissions of all transparency reporting.
Development and maintenance of processes for periodic data review and issue resolution.
Responsible for ensuring that final reports filed with federal and state authorities have been validated by applicable business owners and filed with applicable government authorities.
Interfaces with vendor to ensure completeness, accuracy, and timeliness of data.
Works with Finance and IT management to establish and gain consensus on project goals, objectives, schedule, and deliverables.
Updates management and other stakeholders on projects' status, risks, and resource requirement.
Responsible for ongoing management of resources (internal or external) dedicated to transparency reporting.
Provides field support by triaging and addressing issues.
Lead for resolution of transparency reporting-related discrepancies and providing clarifications related to associated transparency reporting policies.
Responsible for helping define new compliance business processes for all new/changing federal and state transparency reporting as laws are enacted or passed.
Partners with IT in implementing systems to support the companys compliance related technology initiatives.
Responsible for data analytics for the compliance program and associated reporting (includes gathering supporting information and preparing dashboards for compliance metrics and monitoring/auditing results and findings for communication to various levels in the company).
Support the companys overall development and delivery of a compliance program, policies/procedures and trainings in compliance risk areas throughout the company by completing tasks like policy development, training and monitoring of Sales and Commercial field and home office activities.
EDUCATION AND EXPERIENCE
Bachelors degree required preferably in accounting or finance (advanced degree, e.g. J.D. or Masters preferred).
A minimum of 5 years of compliance, finance, accounting, legal or other business function experience required; preferably pharmaceutical/device/healthcare.
Project Management and/or audit experience a strong plus.
The person performing in this position is expected to possess the following qualifications:
Strong ethics and integrity.
Ability to understand policies and examine expenditures in light of applicable guidelines and to identify problem areas and propose solutions across functions and levels.
Ability to communicate effectively with cross functional senior management, the sales force, marketing personnel and cross-functional teams.
Knowledge of various laws, regulations, and industry guidance that affect the companys compliance program, including 2003 OIG Compliance Program Guidance for Pharmaceutical Manufacturers, PhRMA Code on Interactions with Healthcare Providers, PDMA, AMA, and industry guidance documents, regulations regarding the promotion of marketed products, and the False Claims Act and anti-kickback statutes.
Strong computer skills and extensive experience with use of analytical tools for data analysis.
Experience with monitoring and auditing pharmaceutical company activities.
Demonstrated ability to build and manage effective relationships with strong inter-personal skills and business acumen.
Effective time management skills and ability to handle multiple projects simultaneously.
||101 Enterprise |
Aliso Viejo, CA 92656