MMS
501 - 1000 employees
💊 Pharmaceuticals
🧬 Biotechnology
☁️ SaaS
💰 Private Equity Round on 2022-06
Pharmaceuticals • Biotechnology • SaaS
MMS is a leading data-focused Contract Research Organization (CRO) specializing in pharmaceutical and biotechnology innovation. With a strong emphasis on regulatory expertise and technological innovation, MMS provides a comprehensive range of services including regulatory submissions, data management, biostatistics support, medical writing, and pharmacovigilance. The company is known for its AI and technology-driven platforms like Datacise®, PVantage®, and Automatiqc®, which enhance efficiency and streamline clinical trial processes. MMS supports its clients from the investigational new drug application phase through to marketing authorization and post-approval, offering integrated solutions to accelerate drug development and mitigate risks. Recognized as a top workplace and for leadership in ESG sustainability, MMS is committed to empowering its employees and driving successful outcomes for its clients on a global scale.
Principal Medical Writer
🕒 April 21
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MMS
501 - 1000 employees
💊 Pharmaceuticals
🧬 Biotechnology
☁️ SaaS
💰 Private Equity Round on 2022-06
Pharmaceuticals • Biotechnology • SaaS
MMS is a leading data-focused Contract Research Organization (CRO) specializing in pharmaceutical and biotechnology innovation. With a strong emphasis on regulatory expertise and technological innovation, MMS provides a comprehensive range of services including regulatory submissions, data management, biostatistics support, medical writing, and pharmacovigilance. The company is known for its AI and technology-driven platforms like Datacise®, PVantage®, and Automatiqc®, which enhance efficiency and streamline clinical trial processes. MMS supports its clients from the investigational new drug application phase through to marketing authorization and post-approval, offering integrated solutions to accelerate drug development and mitigate risks. Recognized as a top workplace and for leadership in ESG sustainability, MMS is committed to empowering its employees and driving successful outcomes for its clients on a global scale.
📋 Description
• 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 PhD degree 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
🏖️ Benefits
• Great Place to Work certified organization • Supportive, innovative team environment • Exceptional culture and industry-best employee retention rate
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