Project Coordinator

Compensation

: $50,560.00 - $78,130.00 /year *

Employment Type

: Full-Time

Industry

: Advertising/Marketing/Public Relations



Project Coordinator?

North Wales, PA?

8+ month Contract?




Summary:

Follow established process to build digital submission packages of promotion materials for eCTD transmission to FDA. Perform quality check to ensure materials align to documented requirements and meet expected deadlines. Oversee submissions to ensure accurate and efficient formatting of materials according to company requirements and providing submission package materials to Publishing area. Perform close out activities for documentation and archiving. Complete necessary compliance and systems training to perform assigned tasks. Work in a fast-paced environment in collaborative fashion with Regulatory and Commercial team members. Advise and consult on promotion submission process and standards in the development and implementation of US marketing strategy and promotional programs.



Experience Preference:

  • Promotional Operations supporting pharmaceutical/biologics/devices submission process to FDA, or similar experience in Quality Assurance and /or Regulatory Submission Management, Regulatory Publishing.

  • Submission planning and filing of materials with FDA or health authorities.

  • Detailed knowledge of eCTD Backbone File Specification Module 1 and folder structure for electronic submission to FDA.

  • Basic understanding of FDA regulations relating to advertising and promotion for prescription products.

  • Experience with Microsoft Windows and creating digital file libraries and folders.

  • Understanding of quality requirements for health authority submissions.

  • Strong interpersonal and communication abilities.

  • Ability to work independently.

  • Ability to follow split schedule for working on-site and telecommuting throughout the week.

  • Expertise in successfully leading multiple complex cross-functional projects?making effective speedy decisions and investigating and solving problems, on time, with measurable improvements.

  • Candidate can be remote a couple days a week.

  • Experience in lieu of a Degree will be considered.




?TOP skills:


  • Technical Knowledge of eCTD

  • Ability to collaborate and communicate effectively




Company Description:

About Ascent:



Ascent is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. Ascents fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Ascent works as both a reliable supplier in support of programs, as well as a Strategic Advisor in support of enterprise efforts to establish best in class preferred vendor programs. Ascent was ranked in the 2007 and 2008 Inc. 500 and recognized specifically for its innovative work in staff augmentation support of Large Enterprise preferred vendor accounts.



If you are ready to propel your career to new heights read on. We are looking for talented and dedicated colleagues to join our phenomenal team. At Ascent, we have created an environment where culture, commitment and opportunity converge to yield a truly unique place to work. We know that every employee has something important to say and that every employee is integral to our success. Where else can you walk over to a founder and talk about your ideas to help build our business and have that idea implemented in 48 hours? More importantly, we do everything we can to make sure our employees not only have great jobs, but great lives.


* 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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