Quest Diagnostics
Sr Corporate Counsel - FDA/Regulatory
At a glance
Location: US-NJ-Secaucus Map
Posted: 01/01/2022
Closing: 01/31/2022
Degree: Not Specified
Type: Full-Time
Experience: Not Specified
Quest Diagnostics
Job description

Sr Corporate Counsel, FDA

Recognized by FORTUNE magazine as one of the “World’s Most Admired Companies,” Quest Diagnostics is the world's leading provider of diagnostic testing, information and services that doctors and patients need to make better healthcare decisions. They are pioneers in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care.

With corporate headquarters in Secaucus, NJ, Quest Diagnostics is a Fortune 500 company traded on the New York Stock Exchange (NYSE: DGX) and included in the Dow Jones Sustainability World Index.  With 2020 revenues of $9.44 Billion and approximately 50,000 employees and 6,600 patient locations across the US, Quest Diagnostics serves half of the physicians and hospitals in the US with their large variety of products and services. 

The company offers the broadest access to diagnostic testing services through its network of laboratories and patient service centers and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics also provides services to employers, life insurance companies, other commercial labs, clinics, health plans, government agencies, and organizations involved in clinical trials research.

Approximately 150 million times each year, patients and their physicians rely upon Quest Diagnostics results to make important healthcare decisions and approximately one third of U.S. physicians – and many of the country’s leading hospitals and health systems – relies on Quest Diagnostics healthcare information solutions to foster better patient care and outcomes.

Awards/Recognitions


•         FORTUNE magazine's "World's Most Admired Companies" list for 7 consecutive years; one of only five companies to attain Most Admired status in the "Health Care, Pharmacy and Other Services" industry category. 


•         Fortune magazine’s Fortune 500 list


•         Forbes® Global 2000


•         Forbes®' America's Best Employers List for third consecutive year


•         Forbes® 2020 America’s Best Employers for Women for second consecutive year


•         S&P 500


•         Barron’s 500


•         Member of the Dow Jones® Sustainability World Index


•         Included in the FTSE4Good, Calvert, and Ocean Tomo sustainability indices


•         Listed in the most recent Newsweek Green Rankings


•         Consistently named one of the best places to work in U.S. business journal rankings


•         Named a Diversity Inc Noteworthy Company for third consecutive year


•         Listed on the Disability Equality Index® (DEI), a joint initiative of the American Association of People with Disabilities (AAPD) and the US Business Leadership Network (USBLN), recognizing companies for prioritizing the inclusion of people with disabilities


•         Named Top 23 ‘Best Places to Work for LGBTQ Equality’ in New Jersey


•         Named a Best Place to Work for LGBTQ Equality by scoring a perfect 100 on the Human Rights Campaign Foundation’s 2021 Corporate Equality Index (CEI) for the fifth consecutive year.


•         Achieved Cancer Gold Standard accreditation from the CEO Roundtable on Cancer, recognizing our actions to reduce the cancer risk of employees and their families


•         Received C. Everett Koop National Health Award for Efforts to Promote Employee Health in 2020

Diagnostic Testing Services

Quest Diagnostics is the world’s leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. Their services range from routine blood tests — such as total cholesterol, Pap testing and white blood cell count — to complex, gene-based and molecular testing. They perform medical tests that aid in the diagnosis or detection of diseases, measure the progress or recovery from a disease or confirm that an individual is free from disease. In addition, they have specialized expertise in cancer, cardiovascular diseases, infectious diseases, and neurology.

Outlook

In the $60 Billion and growing US Diagnostic Testing Market, Quest Diagnostics is the leader. Quest Diagnostics’ reputation as a leading innovator, provider of high value, low cost solutions and its financial strength and flexibility make it well positioned to capitalize on the evolving healthcare landscape.

Quest Diagnostics’ long-term strategy is to become the undisputed world leader in diagnostic testing, information and services. To drive this profitable growth, Quest Diagnostics plans to leverage capabilities to create differentiation:


•         Deliver Innovative Solutions


•         Leverage their Unparalleled Access and Distribution Network


•         Expand their relationships with large payors and health systems


•         Deliver Superior Patient Experiences

 

Position Description

The successful candidate will be responsible for providing legal advice and support to help ensure that Quest Diagnostics test offerings and facilities are compliant with the relevant laws, regulations and guidelines that are under the purview of the FDA and the Clinical Laboratory Improvement Amendments of 1988 (CLIA) (together “dual requirements”).  This includes our manufacturing, transplant lab and blood transfusion labs as well as our clinical laboratories and the inter-relation between the dual requirements. It will entail counseling Quest scientists and medical personnel as to the requirements they must meet in the development and validation of laboratory tests. Additionally, the position will require:


•         Guiding the company’s Companion Diagnostics, Pharmacogenomics, personalized medicine and clinical research projects through development and FDA submissions


•         Legal oversight of the Company’s marketing review process for compliance with FTC and FDA marketing requirements and others.


•         Provide guidance and counsel to our regulatory staff regarding regulatory requirements, FDA inspections and preparedness for such inspections at our manufacturing facility and our transplantation laboratories.  Quest also offers employee wellness programs, drug abuse testing for employment and insurance risk testing under SAMSHA.  


•         Provide direction and oversight on how to empower patients through home specimen collection, as well as knowledge of foreign medical device laws, such as Canada and the EU


•         Evaluate incidents for adverse event reporting and approve filing of Biological Product Deviation Reports if needed for Quest and its Joint Ventures

Knowledge and Experience


•         Knowledge of FDA Quality System regulations and how they will apply to laboratories under newer developing FDA programs is essential


•         Knowledge related to CLIA, ISO certifications, OSHA, Stark and anti-corruption laws, foreign medical device and laboratory related laws, import and export laws is helpful, but not required


•         Present knowledge of medical device and biologics law and regulations is essential to the job


•         Knowledge of pending legislation affecting the Company is required to assist in meeting new requirements, including site registration, QSR implementation, employee training and marketing compliance


•         Strong knowledge of requirements for OTC clearance and implementation

Required Qualifications


•         A juris doctorate or equivalent from an accredited law school


•         Admission and being in good standing to a state bar within the USA

Preferred Qualifications


•         Science background in biology, chemistry, pharmaceutical, toxicology or related field


•         FDA experience obtained from being an FDA employed attorney, or from a law firm with FDA specialty or as a corporate FDA counsel with focus on medical devices or diagnostics and consumer


•         Ability to interact with Quest Scientific and Medical personnel


•         Ability to counsel Quest business personnel on FDA issues


•         Good communication and inter-personal skills to provide training programs for Quest personnel regarding FDA laws and regulations and compliance


•         Experience related to CLIA and OSHA


•         Experience with international medical device laws, ISO certifications and import/export laws


•         Knowledge of anti-corruption laws

 

To Apply

Please Log In or Register to Upload a Resume and complete the online Application by visiting questdiagnostics.com/careers, clicking “Job Search” and following the prompts. Because of the large number of applicants to job openings, Quest Diagnostics will only contact qualified candidates for interviews.

Quest Diagnostics is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Sr Corporate Counsel - FDA/Regulatory