Submissions Program/Project Manager – Contract

Acumen seeks an experienced project manager to lead and manage the development of clinical and nonclinical regulatory submissions (NDAs/BLAs and INDs), on a project-by-project basis. In this role, you will partner with client teams and coordinate the development of documents that support the regulatory submission. The ideal candidate will have extensive experience with the processes of regulatory submissions as well as working knowledge of the medical writing function, regulatory publishing and the eCTD structure. This is a remote contract opportunity. Compensation is extremely competitive.

Depending on the needs of the project, you will:

• Create and maintain integrated submission timelines
• Define documentation workflows and responsibility matrices
• Facilitate team meetings and communicate project status
• Coordinate the preparation, completion, and handoff of submission deliverables
• Manage or assist with the tracking of deliverables against the submission content plan
• Liaise with the regulatory publisher
• Develop and support document libraries
• Highlight and resolve emerging issues
• Support Acumen team members, manage internal timelines, and liaise with client teams

Requirements:

• 5+ years in the biopharmaceutical industry, with recent experience related to submissions and/or Regulatory Affairs
• Excellent project management skills, preferably applied in the leadership and management of teams
• A solid understanding of drug development, across phases
• Strong communication and interpersonal skills
• Good knowledge of eCTD elements and structure