Submissions Specialist

Company Summary

WAYS Pharmaceutical Services is an innovative team that helps (bio)pharmaceutical organizations prepare and submit their research documents and supporting data to health authorities around the world.  The WAYS team partners with our clients to offer long and short-term solutions. Our services afford flexibility and scalability to growing teams while delivering critical capabilities.  We become seamlessly integrated into our client’s process, and ultimately, help to achieve their submission goals in the most efficient manner.

 

Position Summary

A Submissions Specialist is responsible for providing technical and submission management guidance across all aspects of regulatory operations to ensure quality regulatory submissions are delivered to health authorities.

Key Responsibilities

  • Manage client communication and expectations

  • Manage document and submission publishing tasks from receipt of client information to delivering a valid, high-quality submission to the corresponding health authority

  • Facilitate issue resolution, communicating with the client to ensure all issues are resolved in a timely manner

  • Act as submission project manager, providing resource and timeline estimates for regulatory submissions

  • Collaborate with clients to define project timelines needed to meet client requirements

  • Adhere to WAYS publishing standards, Standard Operating Procedures, and Guides to ensure consistency and efficiency

  • Deliver presentations to clients as needed


Minimum Job Requirements

  • Bachelor’s Degree

  • Minimum 7 years of eCTD Submission Publishing and Submission Management experience in the Pharmaceutical/Life Science industry with both major/planned and lifecycle maintenance submissions

 

Preferred Skills

  • Experience with eCTD publishing software and tools used throughout the (bio)pharmaceutical industry

  • Experience with coordination and publishing to Global Health Authorities in electronic format for both investigational and marketing applications

  • Working knowledge of (bio)pharmaceutical Regulatory Submission requirements as defined by International Conference of Harmonization and Global Health Authority Guidelines

  • Strong communication skills

  • Ability to work independently; self-starter
     

Employment Status

  • Full Time

  • Remote

Applicants should submit a resume to humanresources@waysps.com