Senior Nonclinical Writer - Lead Regulatory Submissions

MMS Holdings Inc; United States; Remote; USD 90,000 - 140,000; Full time

Job summary

MMS Holdings Inc is seeking a senior regulatory writer to join a remote, full‑time role focused on development, writing and management of highly technical nonclinical documents for regulatory submissions. You will lead projects, ensure scientific integrity, and collaborate across regulatory, safety and cross‑functional teams.

Ideal candidates have 5+ years regulatory nonclinical writing experience, strong writing/analytical skills, and familiarity with GLP, ICH guidelines, and drug development

Qualifications

• BS+ in pharmacology, toxicology, biology or chemistry or related field; industry experience in regulatory writing.
• Knowledge of GLP, ICH guidelines and applicable regulatory requirements.
• 5+ years of pharmaceutical regulatory nonclinical writing experience.
• Strong writing and analytical skills.
• Proficiency with MS Office applications.
• Hands‑on experience with clinical trial and pharmaceutical development preferred.
• Basic understanding of CROs and scientific & nonclinical data/terminology and drug development processes.

Responsibilities

• Lead development, writing and management of highly technical nonclinical documents for regulatory submissions.
• Independently lead projects and write nonclinical submission documents for INDs/CTAs/NDAs/BLAs/MAAs.
• Analyze pharmacokinetics, pharmacology and toxicology data and translate into submission documents.
• Develop mapping plans for Module 2.4 and 2.6 eCTD structures.
• Collaborate with cross‑functional teams including clinical ops, regulatory, safety and biostats.
• Ensure documents conform to sponsor formats, processes and regulatory guidelines.

Skills

Regulatory writing

Project leadership

Regulatory guidelines knowledge

Communication skills

Cross-functional collaboration

Education

BS+ in pharmacology/toxicology/biology/chemistry

Tools

SharePoint

Veeva RIM

EndNote

MS Office

Job description

MMS Holdings Inc is seeking a senior regulatory writer to join a remote, full‑time role focused on development, writing and management of highly technical nonclinical documents for regulatory submissions. You will lead projects, ensure scientific integrity, and collaborate across regulatory, safety and cross‑functional teams.

Ideal candidates have 5+ years regulatory nonclinical writing experience, strong writing/analytical skills, and familiarity with GLP, ICH guidelines, and drug development