Job Number: 21210198
REGULATORY OPERATIONS PUBLISHER
Can be Onsite/Remote or Hybrid.
- This person will report to the Director Regulatory Operations and Innovation.
- Can independently troubleshoot most technical publishing issues as needed to support publishing deadlines .
- 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 (Insight Publisher/Veeva Publishing), Vault RIM, e-CTD publishing tools, ISI Toolbox 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 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.
- A Bachelor's Degree or equivalent experience required .
- A minimum of 3-5 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 .
- 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 life cycle aspect of record retention .
- Uses and participates in a team approach .
- Willingness and ability to implement action plans without being told to do so .
- A great attitude, communication skills, do what it takes mindset and someone that leans in and gets the job done .
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Reden: red@alphaconsulting.Com
ALPHA'S REQUIREMENT #22-02233
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE