Senior Medical Writer & Regulatory Submissions Lead

MMS Holdings Inc; Toronto; Remote; CAD 90,000 - 130,000; Full time

Job summary

MMS Holdings Inc. is seeking a senior Medical Writer to join our regulatory writing team. You will evaluate literature, draft protocols, ICH-compliant study documents, and collaborate with clients to ensure scientific rigor and timely delivery.

Ideal candidates have 6+ years of regulatory writing experience, strong leadership, and expert Word/Office skills. You will mentor others, manage projects, and contribute to submission readiness across multiple project teams.

Qualifications

• Bachelor’s, Master’s or PhD in scientific, medical, clinical discipline or related field is required with at least 6 years of regulatory writing experience
• Substantial clinical study protocol experience as lead author
• Experience leading and managing teams while authoring regulatory documents with aggressive timelines
• Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus
• Understanding of clinical data
• Exceptional writing skills are a must
• Excellent organizational skills and the ability to multi-task are essential prerequisites
• Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools
• Experience being a project lead or managing a project team
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus
• Not required, but experience with orphan drug designations and PSP/PIPs a plus

Responsibilities

• Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias
• Write and edit clinical development documents, including but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials and publications to medical journals
• Complete writing assignments in a timely manner
• Maintain timelines and workflow of writing assignments
• Practice good internal and external customer service
• Highly proficient with styles of writing for various regulatory documents
• Expert proficiency with client templates & style guides
• Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects
• Contribute substantially to, or manages, production of interpretive guides
• Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary
• Mentor medical writers and other members of the project team who are involved in the writing process

Skills

Regulatory writing

Leadership

Project management

Communication

Education

Bachelor/Master/PhD in scientific/medical field

Tools

MS Word

Excel

PowerPoint

Job description

MMS Holdings Inc. is seeking a senior Medical Writer to join our regulatory writing team. You will evaluate literature, draft protocols, ICH-compliant study documents, and collaborate with clients to ensure scientific rigor and timely delivery.

Ideal candidates have 6+ years of regulatory writing experience, strong leadership, and expert Word/Office skills. You will mentor others, manage projects, and contribute to submission readiness across multiple project teams.