Senior Nonclinical Writer — Regulatory Submissions Lead

MMS; Greater London; Remote; GBP 50,000 - 75,000; Full time

Job summary

MMS is an award-winning, data-focused clinical research organization with a Great Place to Work certification. This full-time, remote role supports UK-based candidates and centers on developing and managing highly technical nonclinical documents for regulatory submission.

The position requires leading projects, writing modules for eCTD submissions (2.4/2.6), IBs and NCSRs, and interpreting PK/TOX data, in alignment with GLP, ICH and EMA/FDA guidelines.

Qualifications

• BS or higher in pharmacology, toxicology, biology, chemistry or related field with industry regulatory writing experience.
• Knowledge of GLP, ICH guidelines and regulatory requirements.
• 2+ 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.

Responsibilities

• Develop and write nonclinical regulatory documents (Module 2.4/2.6 eCTD, IB, Nonclinical Study Reports, RTQs).
• Lead projects independently with minimal oversight and ensure the nonclinical package aligns with regulatory guidelines.
• Map nonclinical study data into the structure of Module 2.4 and 2.6 eCTD submission documents.
• Interpret and analyze pharmacokinetics, pharmacology, and toxicology data and integrate into documents.
• Collaborate with cross-functional teams and attend client meetings.
• Lead others to complete complex projects and ensure sponsor formats and processes are met.
• Operate in an environment requiring negotiation, collaboration, and analytical judgment.

Skills

Regulatory writing

Nonclinical writing

Project leadership

Communication skills

Analytical skills

Education

Bachelor's degree in pharmacology, toxicology, biology, chemistry or related field

Tools

MS Office

SharePoint

Veeva RIM

EndNote

PleaseReview

Job description

MMS is an award-winning, data-focused clinical research organization with a Great Place to Work certification. This full-time, remote role supports UK-based candidates and centers on developing and managing highly technical nonclinical documents for regulatory submission.

The position requires leading projects, writing modules for eCTD submissions (2.4/2.6), IBs and NCSRs, and interpreting PK/TOX data, in alignment with GLP, ICH and EMA/FDA guidelines.