Remote | Competitive Compensation

Acumen Medical Communications is a distinguished technology and services firm empowering companies in pharmaceutical development. Clients choose us not because we’re the largest or least expensive option, but because the quality of our work sets us apart. They trust us to get it right the first time, and we pride ourselves on accuracy, thoroughness, and a level of polish that ensures every project meets the highest standards. To deliver on this commitment, we place a strong emphasis on attracting top talent and compensating them accordingly.

Acumen seeks an experienced Regulatory Affairs Project Manager as a contract role to lead and oversee the development of clinical and nonclinical regulatory submissions (NDAs/BLAs and INDs), on a project-by-project basis. In this role, you will partner closely with client teams to coordinate the creation and delivery of documents that support the regulatory submission.  The ideal candidate will have extensive experience with regulatory submission processes, a working knowledge of medical writing, regulatory publishing, and the eCTD structure, and be an experienced professional who can quickly assume responsibility and execute submission tasks with minimal ramp-up.

Key Responsibilities:

• Create and maintain integrated submission timelines

• Define documentation workflows and responsibility matrices

• Drive cross-functional communication and collaboration with senior leaders on projects, including timelines, status, risks, and issues.

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

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

• Serve as liaison with regulatory publishers.

• Develop and support document libraries

• Proactively identify roadblocks and/or constraints impacting project execution.

• 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

• Minimum of a Bachelor’s degree in a relevant field (e.g., life sciences, pharmacy, or related discipline). 

• PMP and/or RAC certification preferred.

• Demonstrated project management expertise, with a track record of leading cross-functional teams.

• Comprehensive understanding of drug development across clinical phases.

• Strong communication, organizational,  and interpersonal skills

• Solid knowledge of eCTD elements and structure