Regulatory Operations Publisher

JOB FUNCTION: Scientific
JOB TYPE: Temp
LOCATION: Princeton, NJ
COMPENSATION: $53/hr
REMOTE / ONSITE: Remote
POSTED: Jul 21, 2022

Our client, a global pharmaceutical company seeking a Regulatory Operations Publisher to join their team!

Salary/Hourly Rate:

Max pay rate of $53.50/hr, depending on experience

Position Overview:

The Regulatory Operations Publisher will be responsible for ensuring eCTD submissions are compliant to the FDA and Health Canada (Veeva Vault, Insight Publisher, Lorenz eValidator) and be responsible for end to end publishing process for submissions to FDA and Health Canada.

Responsibilities of the Regulatory Operations Publisher:

  • Independently troubleshoot most technical publishing issues as needed to support publishing deadlines
  • Process electronic files incorporating bookmarks, links and other formatting requirements and transmits these for filings and related regulatory notifications in accordance with established timeframes
  • Responsible for the management, publishing, and submission of Electronic Common Technical Document (eCTD) submissions, including major filings Technology support
  • Work on a daily basis with technology
  • Promote the best use of new technologies for submissions includes, but is not limited to the FDA gateway, publishing software (Insight Publisher/Veeva Publishing), Vault RIM, e-CTD publishing tools, ISI ToolBox and submissions management tools
  • Thoroughly knowledgeable of governmental regulatory requirements regarding document printing, publishing and transmission and is able to compile and transmit both routine and major filings in an accurate and timely fashion
  • Oversee tracking, coordinating, publishing, and submitting of all product submissions
  • Will be required to update epub information as needed and timely archive submissions following internal procedures
  • Use Vault RIM, Veeva Publishing, Insight Manager
  • Publisher, Lorenz eValidator where necessary to support eCTD submissions
  • Work with line of business to define submission plan and avoid common pitfalls-may sit on Project Teams if deemed appropriate by Director
  • Work in direct relation with TA to coordinate submission timelines
  • Responsible for end to end publishing process for submissions to FDA and Health Canada

Qualifications for the Regulatory Operations Publisher:

  • Minimum of 3 to 5 years of experience within the regulatory environment, with a concentration in eCTD publishing
  • High commitment to quality of all projects
  • A do what it takes mindset and positive attitude
  • IT competencies are a plus
  • Keen attention to detail and skill in reviewing to ensure accuracy
  • Preferred Training in Vault RIM/submissions/Veeva Publishing, Insight Manager, Publisher, Validator, ISI Toolbox, Lorenz eValidator, ESG gateway
  • Previous hands on experience with the eCTD processes behind the compilation of Investigational New Drugs (INDs)/ New drug application (NDAs)/Amend/Supplements
  • Specific or technical job skills: Thorough understanding of the eCTD structure as well as FDA and International Conference on Harmonization (ICH) specifications for eCTD submissions
  • Ability to cope and work effectively within an environment that has quickly changing processes and procedures
  • Ability to manage multiple projects simultaneously, prioritize, work effectively and efficiently under deadlines
  • Understanding of rationales behind good file convention and naming practices

Education Requirements:

  • Bachelor’s degree or equivalent experience is required

Benefits:

  • Atrium Care package available, upon eligibility
As a woman-owned firm, we value diversity. We are an equal opportunity employer and will consider all applications without regard to race, sex (including gender, pregnancy, sexual orientation and gender identity), age, color, religion or creed, national origin or ancestry, veteran status, disability (physical or mental), genetic information, citizenship or any other characteristic protected by law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Position ID: 112053