About MMS Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.

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

Requirements

Bachelor’s, Masters or PhD Degree in scientific, medical, clinical discipline or related field is required with at least 6 years of previous regulatory writing experience; Masters or PhDdegree is preferred

Substantial clinical study protocol experience, as lead author, required

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

Robust 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

Please consider your application unsuccessful if we do not reach out to you within 14days of your submission.

📌 Principal Medical Writer (Toronto)
🏢 MMS Holdings
📍 Toronto