Senior Medical Writer (Remote - Canada)

Job summary

The Medical Writer will critically analyze medical literature and write various clinical development documents, including protocols and study reports. They will also manage project timelines, interact directly with clients, and mentor team members throughout the writing process.

Job details

About MMS MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating. Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide. MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger. For more information, visit www.mmsholdings.com [http://www.mmsholdings.com/] or follow MMS on LinkedIn [https://www.linkedin.com/company/mms-holdings-inc-/]. 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 * At least 3 years of previous experience in the pharmaceutical industry * Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience * The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline * 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 14 days of your submission.

What you’ll do

The Medical Writer will critically analyze medical literature and write various clinical development documents, including protocols and study reports. They will also manage project timelines, interact directly with clients, and mentor team members throughout the writing process.

Requirements

Candidates must have at least 3-5 years of industry regulatory and clinical medical writing experience, along with a degree in a scientific or clinical discipline. Proficiency in MS Office tools and a strong understanding of federal regulations and ICH guidelines are required.

Listed skills

• Project management · Preferred
• Communication Skills · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Medical writing
• Regulatory writing
• Clinical study protocols
• Clinical study reports
• Regulatory submissions
• Clinical data interpretation
• Project management
• Mentoring
• ICH guidelines
• Good clinical practices
• MS Word
• MS Excel
• MS PowerPoint
• Scientific writing
• Communication skills
• Orphan Drugs
• Regulatory Documents
• Style Guides
• Talent Acquisition
• Workflow Management
• Organizational Skills
• Technology Solutions
• Medical Devices
• Microsoft Word
• Microsoft Excel
• Biotechnology
• Customer Service
• Pre-Clinical Development
• Medical Ethics
• Medical Guideline
• Clinical Trials
• Clinical Study Design
• Clinical Study Reports
• Consulting
• Word Processing
• Marketing
• Good Clinical Practices (GCP)
• Innovation
• Medical Writing
• Multitasking
• Pharmaceuticals
• Microsoft PowerPoint
• Timelines
• Templates
• ICH Guidelines
• Teamwork
• Enthusiasm

Job areas

• Healthcare
• Science & Research
• Consulting
• Data & Analytics
• Medical Writer
• Authors and Related Writers
• Technical Writers

More jobs from MMS