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Senior Corporate Counsel

2 months ago

Secaucus, United States Quest Diagnostics Full time

Overview:

The Senior Corporate Counsel - FDA Medical Device will report to the Chief FDA Counsel and will be primarily responsible for providing advice and counsel on a wide range of legal and regulatory issues related to assay discovery, development, and commercialization.

Responsibilities:
  • Serve as a proactive, ethical, counselor to Quest's robust companion and complementary diagnostics pipeline.
  • Provide support to Regulatory Affairs and Quality Assurance teams engaged in collaborative research and development activities regulated under the Federal Food, Drug, and Cosmetic Act (FDCA).
  • Develop regulatory strategies that maximize opportunities and mitigate risks.
  • Evaluate legal/regulatory exposures related to contract terms, reports, findings, and assessments of regulatory activities carried out by Quest.
  • Provide coherent guidance in written and oral communications to multi-functional teams to ensure compliance with company policies and legal/regulatory requirements.
  • Contribute to the management of relationships with internal clients, build effective working relationships with external clients, and provide high-quality professional legal counsel to support Quest in delivering business strategy and meeting company goals.
  • Identify and resolve other legal issues affecting Quest within the areas of responsibilities of the affected
    functions or business units.
  • Make periodic presentations to peers in the Legal and Compliance Department, other business functions, and management as well as serve on and participate in team projects.
  • Travel as required to FDA-regulated and other business units, as well as to attend meetings and corporate functions. Long-distance travel by commercial air will be required.
  • Perform other legal, administrative, and corporate duties upon request.
Qualifications:
  • A Doctor of Jurisprudence (J.D.) or equivalent degree is required.
  • Must be admitted to at least one state bar, or be eligible for licensure as a registered in-house counsel.
  • A minimum of 8 years of legal experience at a law firm and/or in-house, including medical device, pharmaceutical, biotech and/or experience working for a regulatory agency or Competent Authority overseeing IVDs.
  • A solid understanding of the biotech/pharmaceutical and/or medical device/IVD industry, including product
    development, commercialization, and the legal and regulatory environment.
  • A proven, demonstrable record of successfully partnering with colleagues on clinical trial applications and/or marketing clearances, approvals, licenses, or authorizations for medical products in the US and/or outside of the US.
  • Current and thorough knowledge of the Food, Drug & Cosmetic Act, associated regulations, FDA Guidance, and regulatory practices of the U.S. Food and Drug Administration in the regulation of medical devices/IVDs.
  • Current and thorough knowledge of IRB/Ethics Committee and human subject protection regulations, and
    international standards for Good Clinical Practices.
  • Working knowledge of clinical laboratory law, regulations, and legal issues is highly desirable.
  • Knowledge of companion diagnostics, genetics, pharmacogenetics/pharmacogenomics, and/or FDA regulation of pharmaceuticals is also desirable.
  • An understanding of US Anti-Kickback statute, Foreign Corrupt Practices Act, Export Control Reform Act, and Export Administration Regulations is a plus.
  • Experience with EU Clinical Trial Regulations, MDR, and IVDRs is highly desirable.

Required Work Experience

  • Interpreting and advising on the application of regulations and laws impacting research and global development within the biopharmaceutical and/or medical device industry. These include Good Clinical Practices (GCP), US FDA regulation of clinical trials, marketing submissions, post market obligations, and international standards and harmonization efforts for multinational clinical studies.
  • Evaluating the legal sufficiency of Clinical Trial Agreements, Informed Consent Forms, IRB/Ethics Committee and/or regulatory submissions.
  • Responding to regulatory authorities and/or ethics committees, analyze potential solutions, and creating actionable recommendations based on the overall value of the solution for the key participants.
  • Accurately researching complex regulatory and legal issues and delivering timely and responsive solutions with limited guidance.
  • Communicating regulatory and legal advice at all levels of an organization.
  • Effectively partnering with outside counsel, coaching colleagues in other functional areas as well as other attorneys, and supporting staff working on clinical investigations and complex co-development transactions.
  • Designing and delivering experiential training for adult learners on regulatory law topics.

Required Skills and Attributes

  • Strong legal drafting skills.
  • Strong interpersonal skills, including diplomacy and flexibility, and the ability to communicate effectively with partners at all levels.
  • Good judgment and ability to maintain an objective perspective, particularly when resolving legal risk of clinical matters.
  • Ability to work well independently and on a team, and the ability to prioritize effectively.
  • Resilience and perseverance while supporting a sophisticated growing clinical business.
  • Cultivation of a culture of inclusivity.

While we appreciate and value our staffing partners, we do not accept unsolicited resumes from agencies. Quest will not be responsible for paying agency fees for any individual as to whom an agency has sent an unsolicited resume.

EEO:

Quest Diagnostics is an equal employment opportunity employer. Our policy is to recruit, hire and promote qualified individuals without regard to race, color, religion, sex, age, national origin, disability, veteran status, sexual orientation, gender identity, or any other status protected by state or local law. Quest Diagnostics observes minimum age requirements established by federal, state and/or local laws, and will ask an applicant for verification when deemed necessary.