MM S 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.
Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards.
With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma's international awards programs for the last three consecutive years.
For more information, visit (url removed) or follow MMS on LinkedIn.
We are looking for consultants interested in joining our extended team!
Under mínimal 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
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 & Importante Azienda guides
Interact directly and independently with client to coordinate all facets of projects; competentcommunicator 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
Substantial Oncology experience required
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
Experience being a project lead, or managing a project team
Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus
Substantial clinical study protocol experience, as lead author, required
Experience leading and managing teams while authoring regulatory documents with aggressive timelines
Not required, but experience with orphan drug designations and PSP/PIPs a plus