MMS
Senior Medical Writer (Remote)
MMS
is an innovative, data‑focused contract research organization (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.
About MMS 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 drives our business forward, and we foster enthusiasm, collaboration, and teamwork to strengthen the global and diverse talent pool.
Responsibilities
Under minimal supervision, critically evaluate, analyze, and interpret medical literature to select primary resource materials to support adequate study design, statistical significance, scientific rigor, and absence of bias.
Write and edit clinical development documents, including clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1–2.7.4 and 2.5 documents, presentation materials, and manuscript submissions to medical journals.
Complete writing assignments in a timely manner and maintain timelines and workflow.
Practice good internal and external customer service.
Demonstrate high proficiency with styles of writing for various regulatory documents and client templates & style guides.
Interact directly and independently with clients to coordinate all facets of projects and communicate effectively.
Contribute substantially to, or manage, production of interpretive guides.
Take ownership of assignments, proactively consulting other project team members and department representatives for information or guidance as needed.
Mentor medical writers and other project‑team members involved in the writing process.
Requirements
At least 3–5 years of experience in industry regulatory writing and clinical medical writing, with a minimum of 3 years in the pharmaceutical industry.
Bachelor’s, Master’s, or Ph D in a scientific, medical, or clinical discipline.
Substantial experience as lead author on clinical study protocols.
Experience leading and managing teams while authoring regulatory documents under aggressive timelines.
Knowledge of clinical data and regulatory submissions (e.g., clinical study reports) presented to regulatory authorities is a plus.
Exceptional writing skills and excellent organizational skills with the ability to multi‑task.
Expert proficiency in MS Word, Excel, PowerPoint, and related word‑processing tools.
Experience as a project lead or in managing a project team.
Strong understanding of federal regulations, Good Clinical Practice, and ICH guidelines is a plus.
Experience with orphan drug designations and PSP/PIPs is an additional plus.
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is an innovative, data‑focused contract research organization (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.
About MMS 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 drives our business forward, and we foster enthusiasm, collaboration, and teamwork to strengthen the global and diverse talent pool.
Responsibilities
Under minimal supervision, critically evaluate, analyze, and interpret medical literature to select primary resource materials to support adequate study design, statistical significance, scientific rigor, and absence of bias.
Write and edit clinical development documents, including clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1–2.7.4 and 2.5 documents, presentation materials, and manuscript submissions to medical journals.
Complete writing assignments in a timely manner and maintain timelines and workflow.
Practice good internal and external customer service.
Demonstrate high proficiency with styles of writing for various regulatory documents and client templates & style guides.
Interact directly and independently with clients to coordinate all facets of projects and communicate effectively.
Contribute substantially to, or manage, production of interpretive guides.
Take ownership of assignments, proactively consulting other project team members and department representatives for information or guidance as needed.
Mentor medical writers and other project‑team members involved in the writing process.
Requirements
At least 3–5 years of experience in industry regulatory writing and clinical medical writing, with a minimum of 3 years in the pharmaceutical industry.
Bachelor’s, Master’s, or Ph D in a scientific, medical, or clinical discipline.
Substantial experience as lead author on clinical study protocols.
Experience leading and managing teams while authoring regulatory documents under aggressive timelines.
Knowledge of clinical data and regulatory submissions (e.g., clinical study reports) presented to regulatory authorities is a plus.
Exceptional writing skills and excellent organizational skills with the ability to multi‑task.
Expert proficiency in MS Word, Excel, PowerPoint, and related word‑processing tools.
Experience as a project lead or in managing a project team.
Strong understanding of federal regulations, Good Clinical Practice, and ICH guidelines is a plus.
Experience with orphan drug designations and PSP/PIPs is an additional plus.
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