Senior Analyst, Compliance Monitor
Position Summary Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions.
Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
Summary: This newly created position will provide support for a broad range of compliance issues, with a focus on compliance monitoring and reviewing and approving external funding requests.
The position requires an understanding of healthcare laws, including the Food, Drug and Cosmetic Act, fraud and abuse laws, as well as the compliance enforcement environment.
The ideal candidate will have strong communications skills, be proactive, be able to work independently and collaboratively in a team environment, and manage multiple projects and clients.
The position will directly interact with clients and departments across Regeneron and the candidate must have proven experience in working collaboratively.
Responsibilities: Oversee the review and approval of external funding requests, including educational grants, exhibits and displays, sponsorships, and charitable donations.
Will serve as voting member on relevant committees for review of these funding requests and will be instrumental in advising and updating relevant policies, procedures and job aids to ensure process efficiencies.
In connection with Compliance Monitoring, (1) conduct monitoring visits with field-based employees, and attend various company-sponsored activities to monitor compliance with laws, regulations, industry codes, and Company policies, (2) assist with implementation of compliance monitoring plan which includes reviewing records and systems relating to interactions with healthcare professionals and institutions and (3) develop and maintain protocols, guidelines and associated internal communication related to Compliance testing and monitoring, as needed.
Review and follow-up on suspected areas of non-compliance in collaboration with Company business leads and investigations team, as needed.
Collaborate with members of the Compliance Department and business leads to help develop and implement remediation plans.
Assist with preparation of quarterly and ad hoc reports and, presentations summarizing auditing and monitoring activities.
Organize training for compliance monitors and learn (1) Company products and indications, (2) industry regulations and guidelines (e.g., laws and regulations regarding pharmaceutical advertising and promotion, Federal Anti-Kickback Statute, False Claims Act, PDMA), Company policies and procedures, and government reporting requirements, as needed.
Requirements: Bachelor's degree from an accredited institution, with an advanced degree preferred.
7 years of compliance professional and/or relevant paralegal experience, with at least 5 years working in a pharmaceutical or biotechnology company Compliance auditing and/or monitoring experience in the pharmaceutical or life sciences industry is preferred.
Exceptional oral and written communication skills, presentation capabilities, interpersonal skills and strong problem solving/conflict resolution skills.
Ability to maintain an independent and objective perspective while developing and maintaining a strong partnership with client organizations.
Ability to communicate and negotiate effectively at all levels throughout the company.
History of self-motivation, working independently on projects, meeting aggressive deadlines, and ability to multi-task and manage competing priorities.
Uncompromising ethics and high standard of personal integrity Demonstrated knowledge and understanding of the Anti-Kickback Statute and False Claims Act, FDA rules and regulations regarding the promotion of pharmaceuticals, corporate integrity agreements, PhRMA code, and other relevant reporting/legal requirements.
Proficiency in Microsoft Office Suite.
Significant travel is required.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry.
Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening.
All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place.
In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
Requisition Number: 13092BR
Associated topics: attorney corporate, business, compliance, compliance department, compliance office, corporate, courtroom, internal, legal, market