Acumen Medical Communications (Contract) CMC Writer Remote · Contractor Company website

Apply for (Contract) CMC Writer

Acumen Medical Communications is a world-premier medical writing and regulatory communications firm serving the pharmaceutical, biotech, and healthcare industries. In addition to our core writing, editorial, and publishing services, we provide deep scientific expertise, precision quality control, and advanced technology solutions purpose-built for regulatory and clinical development. To deliver on this commitment, we place a strong emphasis on attracting top talent and compensating them accordingly.

Acumen is seeking an experienced (Contract) CMC Writer to support client submission teams on a project-by-project basis. This individual will lead the development of CMC content for INDs and nonclinical components of NDAs and BLAs, with a focus on eCTD Modules 2 and 3.

This role is highly collaborative and will work closely with Acumen writers, program managers, editors, publishers, and client stakeholders to deliver submission-ready documents that meet the highest standards of quality and compliance.

Core Responsibilities:

• Lead authorship of CMC portions within Modules 2 and 3
• Work within Acumen and client eCTD templates to ensure consistency and submission readiness
• Partner with client SMEs to shape content, structure, and key messaging
• Draft and refine documents through all stages, including comment resolution and leading review discussions
• Develop and manage document timelines aligned with broader submission plans
• Apply deep knowledge of ICH, FDA, and global regulatory guidance to ensure compliance and scientific rigor
• Collaborate cross-functionally to deliver clear, accurate, and polished documents

Qualifications:

• Advanced degree (PhD, PharmD, MS, or equivalent) in a relevant scientific discipline
• Demonstrated experience in CMC regulatory writing
• Proven track record contributing to eCTD Modules 2 and 3
• Experience supporting IND, NDA, and/or BLA submissions
• Ability to translate complex data into clear, concise, submission-ready content
• Strong organizational skills with the ability to manage timelines and multiple stakeholders
• Experience with biologics is a plus