Specialist - Regulatory Affairs - Regulatory Operations (Westwood)


: $53,190.00 - $95,940.00 /year *

Employment Type

: Full-Time


: Advertising/Marketing/Public Relations

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The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a difference? The PositionSupport the global extent of e-submissions and use of Insight Publisher and/or novoDOCS for regulatory submissions in NNI. RelationshipsThis person will report to the Director Regulatory Operations and Innovation. Essential Functions Can independently troubleshoot most technical publishing issues as needed to support publishing deadlines Participation within industry meetings to increase Novo Nordisk presence in the field of e-submission Performs final quality check of electronic and paper versions of regulatory submissions, as well as the submissions published and processed by the Regulatory Operations Publishing Coordinator Processes 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. The Specialist will work on a daily basis with technology. The Specialist will promote the best use of new technologies for submissions. This includes, but is not limited to the FDA gateway, publishing software, novoDOCS, eCTD publishing tools, ISI Tool Box and submissions management tools The Specialist should be 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 The Specialist will oversee tracking, coordinating, publishing, and submitting of all product submissions. They also will be required to update epub information as needed and timely archive submissions following internal procedures Use Insight Manager and Ezsubs 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 Director; Work in direct relation with TA to coordinate submission timelines Physical Requirements0-10% overnight travel required. Qualifications A Bachelor's Degree or equivalent experience required A minimum of 5 years of experience within the regulatory environment, with a concentration in document management and 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 experience with Insight Manager an Publisher, ISI (CSC) Toolbox, Veeva, Lorenz 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 Harmonisation (ICH) specifications for eCTD submissions The ability to cope and work effectively within an environment that has quickly changing processes and procedures The ability to manage multiple projects simultaneously The ability to prioritize The ability to work effectively and efficiently under deadlines Understanding of rationales behind good file convention and naming practices Understanding of the document management lifecycle aspect of record retention Uses and participates in a team approach Willingness and ability to implement action plans without being told to do so Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-###-####. This contact is for accommodation requests only and cannot be used to inquire about the status of applications. * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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