Remote Senior Nonclinical Writer at MMS

Contribute remotely as a Senior Nonclinical Writer at MMS, a certified Great Place to Work. Your expertise will shape critical nonclinical documents and support the biotech and pharmaceutical industries.

In this full-time role, you will manage and write complex regulatory documents, including eCTD submissions and investigator’s brochures. With at least five years of experience in regulatory writing, you will collaborate with cross-functional teams to ensure document accuracy and alignment with regulatory standards. This position emphasizes strong analytical skills and the ability to lead projects autonomously.

Key Responsibilities:

• Develop and write Module 2.4 and 2.6 eCTD submission documents

• Lead writing projects independently with minimal oversight

• Author based on complex nonclinical study reports

• Interpret pharmacokinetics and pharmacology data effectively

• Collaborate with project management and regulatory operations teams

Requirements:

• BS or higher in pharmacology, toxicology, biology, or chemistry

• 5+ years of nonclinical writing experience

• Strong understanding of GLP and ICH guidelines

• Proficient in MS Office applications

• Hands-on experience with drug development processes

Shape the future of clinical research by utilizing your expertise at MMS.