Depomed, Inc Director, Compliance in Lake Forest, Illinois
City Lake Forest
State Illinois [IL]
Title Director, Compliance
Job ID 1085XX
Date Added 3/7/2018
This position supports the legal and compliance function and will be responsible for assisting in the development, execution and continuous improvement of the compliance program in accordance with the guidance of the Office of Inspector General to ensure compliance with all applicable standards, laws, and regulations, including without limitation the U.S. Anti-Kickback Statutes, the False Claims Act, Sunshine Act (Open Payments), the FDA requirements and HIPAA privacy. This position will support the Chief Compliance Officer & General Counsel with respect to commercial legal and compliance matters and activities as well as other legal and compliance projects as required.
ESSENTIAL JOB FUNCTIONS
•Oversees and manages activity to help ensure compliance with federal, state, and local laws and PhRMA Code with respect to HCP interactions
•Provide advice and training to employees of the Company on the health care compliance program using a solid understanding of U.S. pharmaceutical laws, including regulatory and compliance issues and laws pertaining to interactions with healthcare providers
•Provide legal support to senior management and for wide range of commercial and medical affairs activities related to product launch and ongoing promotion of pharmaceutical products
•Think strategically to help support compliant business practices
•Manage and report to quarterly executive committee reviews of compliance activity and related needs
•Periodically report to Board of Directors on compliance program findings and progress
•Provide legal guidance to Promotional Review Committee
•Provide legal guidance to Medical Review Committee
•Provide legal guidance to Grants Committee
•Stay current on applicable law, regulation, and practice and communicating senior management apprised of current developments
EDUCATION AND EXPERIENCE
•BA/BS degree and JD desired
•Minimum of 5-7 years relevant commercial compliance experience, including prior in-house experience with a biotech/pharmaceutical company
•A solid understanding of U.S. pharmaceutical laws, including regulatory and compliance issues
•A solid understanding of laws pertaining to interactions with healthcare providers (Anti-Kickback, False Claims etc.)
SKILLS AND ABILITIES
•Ability to handle highly confidential and sensitive materials and information with complete discretion
•Ability to provide commercial contracting support also strongly preferred
•Ability to work with external counsel, vendors and business partners
•Ability to work within a very small legal/compliance department, and establish and maintain relationships across multiple corporate functions
•Adaptable and flexible, able to prioritize duties and manage multiple matters from start to finish with minimal supervision Exceptional attention to detail and excellent organizational skills and the ability to work on a variety of tasks and projects simultaneously with minimal supervision.
•Ability to work cooperatively and collaboratively with all functions and levels of the Company
•Proven ability to communicate effectively in a variety of difficult and sensitive situations
•Ability to thrive in a dynamic and past-paced environment
•Able and willing to work from our corporate headquarters in Chicago, Illinois
DEPOMED COMPETENCIES INCLUDE
•Decisions & Judgment
•Ownership & Initiative
•Adaptability & Change Readiness
•Teamwork & Collaboration
Depomed is a leading specialty pharmaceutical company committed to putting the Patient First in everything we do; with a focus on enhancing the lives of patients, families, physicians, providers and in payors through commercialization of products in the areas of pain and neurology, and developing drugs in areas of unmet medical needs.
Depomed currently markets three medicines focused on neuropathic pain and migraine through its Neurology and Pain Business and has an emerging Specialty Business focused on orphan drug indications and areas of unmet medical need.
Depomed has a clear THREE PILLAR strategy for growth:
MAINTAIN a strong/profitable NUCYNTA franchise through a commercialization agreement with Collegium, GROW the Neurology and Pain Business and BUILD a new Specialty Business through a recent Cosyntropin transaction. The company’s strategy is to continue to identify, license and develop new products-that offer enhanced therapeutic options to patient populations that may be underserved by existing therapies.
As part of the transformation strategy, Depomed will be relocating its headquarters to northern Chicago, Illinois. Additional information about location will be shared during the interview process.
Depomed is an AA/EEO/Veterans/Disabled employer