Principal Medical Writer (Remote - Canada)

MMS; Toronto; A distancia; CAD 90.000 - 130.000; Jornada completa

Descripción de la vacante

MMS Holdings Inc. is a data-focused clinical research organization (CRO) recognized for its culture and retention.

With a global footprint across four continents, MMS supports the pharmaceutical, biotech and medical device industries with rigorous data and regulatory submission solutions. The company emphasizes collaboration and inclusion, inviting you to contribute to shaping the future of clinical research.

Formación

• Bachelor’s, Masters or PhD in scientific/medical field with regulatory writing experience.
• Experience leading and managing teams while writing regulatory documents with tight timelines.
• Experience in regulatory submissions and understanding of clinical data.

Responsabilidades

• Evaluate literature to select primary resources for study design and regulatory impact.
• Write and edit clinical development documents including protocols, investigator brochures, CSRs.
• Meet timelines and manage writing workflow; mentor writers and project teams.
• Communicate with clients to coordinate project aspects and ensure quality.

Conocimientos

Regulatory writing

Scientific writing

Project leadership

Educación

Bachelor’s/Master’s/PhD in scientific/medical field

Herramientas

MS Word

Excel

PowerPoint

Descripción del empleo

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.