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Senior Manager, Compliance

Employer
Regeneron Pharmaceuticals, Inc.
Location
Tarrytown, NY, United States
Start date
Dec 11, 2018

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Discipline
Regulatory, Legal/Compliance
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

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:

The Senior Manager, Compliance Department will assist the Director, Compliance and the Compliance Department in executing aspects of Regeneron's Compliance Program and ensuring full compliance will all applicable laws and regulations. Activities will include management and maintenance of all Compliance training delivered through the Learning Management System (LMS), assisting with written policies and procedures, assisting with development and execution of compliance communications and assistance with project management of all compliance related activities across the organization. Position will interact with departments across Regeneron and assist employees in understanding Regeneron compliance policies and procedures.

Responsibilities:

• Manage execution of new online compliance training through the LMS

• Manage on-going release of new hire on-line compliance training through LMS.

• Work closely with administrators to manage all on-line compliance training campaigns

• Analyze Compliance training completion rates and develop reports and recommendations as required

• Manage the tracking and documentation of Regeneron's Compliance program

• Assist with policy development and the creation of compliance tools to assist employees across the organization (e.g., PPTs, quick tips, job aids)

• Assist with developing, enhancing and delivering elements of Regeneron's on-going compliance communication strategy across the organization

#LI-LC1

Requirements:

BA/BS
Experience in LMS management, data analytics and overall healthcare law compliance
7+ years healthcare/pharmaceutical and/or biotech experience.
Knowledge of federal fraud and abuse laws, including ACCME guidelines, the Office of Inspector General reports, and the Food, Drug and Cosmetic Act and an understanding of the roles and authority of government agencies and industry cooperative groups including FDA, OIG, and PhRMA.
Knowledge of the Physician Payments Sunshine Act and aggregate spend reporting requirements

Required Skills

• Exceptional communication skills, including presentation capabilities, interpersonal skills and conflict resolution.

• Excellent negotiation skills requiring exceptional interpersonal communication and oral and written communication skills.

• Ability to persuade with verbal and written communications involving multiple key client groups.

• Ability to maintain an independent and objective perspective while developing and maintaining a strong partnership with the client organizations.

• Exceptional data analytic skills with advanced Excel experience

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.

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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