MMS is a award-winning, data-focused clinical research organization (CRO). 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. 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 positive internal and external customer service Highly proficient with styles of writing for various regulatory documents Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects 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 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;

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 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

📌 Principal Medical Writer (Remote - Canada) Regulatory And Medical Writing Toronto, On, Canada (Winnipeg)
🏢 MMS Holdings
📍 Winnipeg