Principal Medical Writer (Remote - Canada)

MMS; Calgary; Remote; CAD 90,000 - 120,000; Full time

Job summary

MMS Holdings Inc. Calgary seeks an experienced Regulatory Medical Writer to evaluate literature, craft regulatory documents, and coordinate with client teams. This role emphasizes strong writing, regulatory submissions expertise, and leadership of writing projects.

You will mentor peers, manage timelines, and ensure adherence to ICH guidelines and industry standards while delivering high-quality clinical documentation for regulatory submissions.

Qualifications

• Bachelor’s degree in scientific/medical field with regulatory writing exposure.
• Regulatory submissions experience is highly valued.
• Experience leading author teams under tight timelines.

Responsibilities

• Critically evaluate literature to support study design and regulatory documents.
• Write and edit clinical study reports and regulatory modules with accuracy.
• Meet timelines and maintain writing workflows across teams.
• Coordinate with clients, project teams and department representatives.
• Mentor junior writers and drive adherence to templates and guides.

Skills

Regulatory writing

Regulatory submissions

Leadership experience

Client communication

Clinical data understanding

Exceptional writing

Project management

ICH guidelines

Education

Bachelor’s degree in scientific/medical field

Masters or PhD preferred

Tools

MS Word

MS Excel

PowerPoint

Job description

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
• 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

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