Note: The job is a remote job and is open to candidates in USA. Acumen Medical Communications is a world-premier medical writing and regulatory communications firm serving the pharmaceutical, biotech, and healthcare industries. They are seeking an experienced (Contract) CMC Writer to support client submission teams by leading the development of CMC content for regulatory submissions, ensuring high standards of quality and compliance.
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
Skills
- 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
Company Overview