Submissions Senior Publisher

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 Senior Publisher is responsible for providing technical and publishing support across all aspects of regulatory operations to ensure quality regulatory submissions are delivered to health authorities.


Key Responsibilities

  • Client communication

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

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

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


Minimum Job Requirements

  • Bachelor’s Degree

  • Minimum 3 years of Submission Publishing experience in the Pharmaceutical/Life Science industry with both major/planned and lifecycle maintenance submissions

 

Preferred Skills

  • Experience with publishing software and tools used throughout the Pharmaceutical industry

  • Experience with coordination and publishing to Global Health Authorities in electronic format

  • Working knowledge of Pharmaceutical Regulatory Submission requirements as defined by International Conference of Harmonization and Global Health Authority Guidelines

  • Strong communication skills

Employment Status

  • Full Time

  • Remote

Applicants should submit a resume to humanresources@waysps.com