MMS
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 regulatory experience to help clients develop and market life-changing therapies. MMS values enthusiasm, collaboration, and teamwork in a diverse, global talent pool.
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
Proficient with writing styles for various regulatory documents; expert with client templates & style guides
Interact directly and independently with the client to coordinate all facets of projects; communicate effectively for project needs
Contribute substantially to, or manage, production of interpretive guides
Take ownership of a given assignment, proactively consulting other project team members and department representatives as needed
Mentor medical writers and other project team members involved in the writing process
Requirements
At least 3 years of previous experience in the pharmaceutical industry
At least 3–5 years of industry regulatory writing and clinical medical writing experience
Bachelor’s, Master’s, or Ph.D. in scientific, medical, or clinical discipline
Substantial clinical study protocol experience as lead author
Experience leading and managing teams while authoring regulatory documents with aggressive timelines
Experience in regulatory submissions (clinical study reports) presented to regulatory authorities is a plus
Understanding of clinical data
Exceptional writing skills
Excellent organizational skills and the ability to multi-task
Proficiency in MS Word, Excel, PowerPoint, and related tools
Experience as a project lead or managing a project team
Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines is a plus
Not required, but experience with orphan drug designations and PSP/PIPs is a plus
#J-18808-Ljbffr
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
Proficient with writing styles for various regulatory documents; expert with client templates & style guides
Interact directly and independently with the client to coordinate all facets of projects; communicate effectively for project needs
Contribute substantially to, or manage, production of interpretive guides
Take ownership of a given assignment, proactively consulting other project team members and department representatives as needed
Mentor medical writers and other project team members involved in the writing process
Requirements
At least 3 years of previous experience in the pharmaceutical industry
At least 3–5 years of industry regulatory writing and clinical medical writing experience
Bachelor’s, Master’s, or Ph.D. in scientific, medical, or clinical discipline
Substantial clinical study protocol experience as lead author
Experience leading and managing teams while authoring regulatory documents with aggressive timelines
Experience in regulatory submissions (clinical study reports) presented to regulatory authorities is a plus
Understanding of clinical data
Exceptional writing skills
Excellent organizational skills and the ability to multi-task
Proficiency in MS Word, Excel, PowerPoint, and related tools
Experience as a project lead or managing a project team
Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines is a plus
Not required, but experience with orphan drug designations and PSP/PIPs is a plus
#J-18808-Ljbffr