Regulatory Program/Project Manager – Contract

Overview

Our mission is to provide unsurpassed medical writing and clinical development services. We invite you to join our growing team of talented individuals to help our clients successfully navigate regulatory submissions. We are seeking an experienced professional to lead and manage the development of clinical and non-clinical submissions  (INDs and NDAs/BLAs), on a project-by-project basis. In this role, you will partner with client teams of all experience levels and provide the depth of management needed to mitigate common pitfalls and stay on schedule. This remote contract opportunity is a great fit for those with experience in regulatory submissions, medical writing, and/or eCTD publishing. Compensation is extremely competitive.

Depending on the needs of the project, you will:

• Serve as primary project contact

• Create and maintain integrated timelines

• Define documentation workflows and responsibility matrices

• Develop and support document libraries

• Coordinate the preparation, completion, and handoff of submission deliverables

• Liaise with the regulatory publisher

• Manage or assist with the tracking of deliverables against the submission content plan

• Highlight and resolve emerging issues

• Facilitate team meetings and communicate project status

• Support Acumen team members, manage internal timelines, and liaise with client teams

Requirements

• 5+ years in the biopharmaceutical industry, with recent experience in Regulatory Affairs

• Excellent project management skills, preferably applied in the leading and managing of teams

• A solid understanding of drug development, across phases

• Strong communication and interpersonal skills

• Good knowledge of eCTD elements and structure

Click HERE to reach us.