Job Number: 21152904
REGULATORY OPERATIONS PUBLISHER
LOCATION: Can be Onsite/Remote or Hybrid .
- The Clinical, Medical and Regulatory (CMR) department at the client 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 Food & Drug Administration (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 the company, 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.
- Ensuring compliant eCTD submissions to the FDA and Health Canada (Veeva Vault, Insight Publisher, Lorenz eValidator).
- 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), Vault RIM, e-CTD 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 Vault RIM, 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 and 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 5 years of experience within the regulatory environment, with a concentration in eCTD publishing .
- High commitment to quality of all projects.
- 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, 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 appplication(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 and 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 .
- Publishing experience (Ideally Veeva and/or Insight) and Veeva Vault experience (RIM etc).
- A great attitude, communication skills, do what it takes mindset and someone that leans in and gets the job done .
- May have experience with that could be included, but not limited to:
- Veeva Vault (RIM, eTMF, Promomats etc) .
- Veeva Publishing .
- Insight Manager /Publisher .
- Insight Validator .
- ISI Toolbox .
- Lorenz eValidator .
- ESG gateway.
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 #22-02169
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE