Overview

Mallinckrodt is seeking an attorney, with experience in regulatory operations and/or commercial operations, to join the Legal Department located in Bedminster, NJ.  This position will have primary responsibility for reviewing advertising, promotional, training, disease awareness and similar materials for the company’s marketed pharmaceutical and device products, as well as provide counsel, as needed, to the business regarding its commercial contracting activities in accordance with applicable laws and regulations.

ESSENTIAL FUNCTIONS:

  • Review advertising, promotional, training, exhibit panels, disease awareness, and similar marketing materials to ensure that the content is consistent with product labeling, is suitable for the intended audience and meets the applicable legal and regulatory requirements, while achieving Company’s strategic promotional objectives.
  • Represent the legal department within promotional review committees for company brand teams, providing strategic recommendations and guidance on compliance with applicable laws and FDA regulations for appropriate sales and marketing of pharmaceutical and medical device products.
  • Demonstrate knowledge of FDA labeling requirements for the promotion of prescription drugs and medical devices, with ability to successfully apply these to work output. Maintain an awareness of enforcement trends in the pharmaceutical and medical device industry.
  • Advise the business on commercial activities to ensure compliance with company policies, applicable regulations and applicable laws such including the False Claims Act, Privacy Laws, Anti-Kickback Laws, Anti-Trust Laws and Sunshine Reporting.
  • On an as-needed basis, draft, negotiate and amend various legal documents including, but not limited to, confidentiality agreements, supply agreements, master services agreements, licensing agreements, and statements of work.
  • Participate in brand team meetings to keep informed of commercial activities and ensure that Company strategies, programs, policies, practices and initiatives comply with all laws.
  • Work closely with internal teams to establish relationships and deliver consistent, practical legal guidance and support.
  • Must be flexible to perform other duties as assigned by the legal department.
  • Experience with approved products and investigational products preferable.

    REQUIREMENTS:

  • Juris Doctorate and admission to the New Jersey Bar.
  • Minimum of 3 years’ experience in a legal department, pharmaceutical corporation, law firm or related government agency setting.
  • Experience serving on a promotional committee for pharmaceutical brand teams, regulatory review experience and/or and proficiency with document review systems such as VEEVA or ZINC, highly desired.
  • Experience drafting and negotiating contracts.
  • Ability to work independently, cultivate strong inter-functional relationships and think strategically.
  • Ability to effectively work across multifunctional groups with minimal supervision
  • Strong prioritization skills in order to effectively manage workload
  • Proficient in Microsoft Office (primarily Word, Excel, and PowerPoint)

    ORGANIZATIONAL RELATIONSHIPS/SCOPE:

    This position reports to the Vice-President, General Counsel of Commercial Operations.

    WORKING CONDITIONS:

    Typical office conditions and flexibility with hours required depending on business needs.

    DISCLAIMER:

             The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

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