North Wales, PA
8+ month Contract
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.
- 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.
- Technical Knowledge of eCTD
- Ability to collaborate and communicate effectively