Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.
Loxo Oncology Inc., a wholly owned subsidiary of Eli Lilly and Company, ("Loxo") is developing a world-class compliance program. We seek an individual to work with the Head of Compliance at Loxo to help establish and integrate the company's Ethics & Compliance function to enhance the company's strong culture of compliance. Reporting directly to the Head of Compliance at Loxo, this individual will work collaboratively and strategically to drive a culture of ethics, integrity and compliance across the Loxo organization. In this role, you will have the opportunity to partner with all area of the business, at all levels of the organization and with Eli Lilly affiliates.
This role will assist in developing and implementing policies and procedures, compliance training and communications, auditing and monitoring, internal reporting, compliance-related investigations and other initiatives to continuously improve Loxo's Ethics & Compliance Program. This will include implementation and integration of Loxo's Helpline, investigation process, engagement of health care professionals, Transparency & Disclosure obligations, Anti-Bribery Anti-Corruption program, privacy and Global Data Protection Regulations (GDPR) matters and other compliance projects and initiatives.
Roles and Responsibilities of the Position*
Work closely with Head of Compliance on various initiatives including development of key compliance program elements and across all areas of the business including research, development, medical affairs and other business functions
Draft, revise and integrate compliance policies, SOPs, guidelines, and associated internal communications and training plans related to key areas of risk relevant to global pharmaceutical companies and specifically research, development and medical affairs
Design and deliver compliance-related training, including new hire training and policy related training for medical field-based and home office personnel
Integration of the company's state and federal aggregate spend reporting and disclosure obligations, including implementation of the appropriate systems, policies and procedures
Conduct compliance monitoring activities to prevent, monitor and detect compliance-related issues
Provide compliance and policy guidance to business partners
Perform or collaborate in performing investigations of potential compliance issues
Assist with compliance programs such as Anti-Bribery Anti-Corruption/FCPA and Privacy/GDPR compliance
Maintain high level of knowledge of current and emerging laws and regulations and recent enforcement actions and inform and educate business units with tailored communications and relevant training
Required Qualifications and Background
Candidates should have strong academic credentials and 5-7 years of experience in compliance, preferably with prior pharmaceutical or device company or in another health science industry or setting
Knowledge of business and operations of pharmaceutical company, device manufacturer or related health industry
Compliance experience related to research, development and medical affairs areas is a plus
Knowledge of relevant laws and regulations specific to health care industry including False Claims Act, Anti-Kickback statute, FCPA, FDA rules on promotion, PhRMA and other industry codes
Demonstrated experience in implementing some or all compliance program elements such as policies and procedures, compliance training, auditing and monitoring, investigations
Strong verbal and written communication skills
Ability to work well cross-functionally, across multiple areas of the business and at all levels
Self-starter and must be able to work independently with minimal supervision
Compliance business partner mindset to assist business in achieving goals in a compliant manner
Good project management skills and can bring a project to completion in collaboration with multiple functional areas
Articulate with good presentation skills and able to deliver training and clear compliance guidance
Enthusiastic and passionate about the work that we do
Ability to multi-task and handle multiple topics
Detail oriented and well organized
Physical Demands / Travel
The physical demands of this job are consistent with light office duties.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
This position's work environment is in an office and may involve occasional traveling in the US.
The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.
Loxo is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Loxo Oncology, Inc.