MMS
Senior Medical Writer (Project-Based) – Remote
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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.
This role is a remote, project‑based consulting opportunity.
Responsibilities
Under minimal supervision, 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 clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1‑2.7.4, Module 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.
Be highly proficient with styles of writing for various regulatory documents and client templates & style guides.
Interact directly and independently with the client to coordinate all facets of projects; competent communicator skills for projects.
Contribute substantially to, or manage, production of interpretive guides.
Take ownership of assignments, 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.
3‑5 years of industry regulatory writing and clinical medical writing experience.
Bachelor’s, Master’s, or Ph.D. in a 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 a plus.
Understanding of clinical data.
Exceptional writing skills.
Excellent organizational skills and ability to multi‑task.
Proficiency 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.
Seniority Level Mid‑Senior level
Employment Type Part‑time
Job Function Marketing, Public Relations, and Writing/Editing
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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.
This role is a remote, project‑based consulting opportunity.
Responsibilities
Under minimal supervision, 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 clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1‑2.7.4, Module 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.
Be highly proficient with styles of writing for various regulatory documents and client templates & style guides.
Interact directly and independently with the client to coordinate all facets of projects; competent communicator skills for projects.
Contribute substantially to, or manage, production of interpretive guides.
Take ownership of assignments, 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.
3‑5 years of industry regulatory writing and clinical medical writing experience.
Bachelor’s, Master’s, or Ph.D. in a 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 a plus.
Understanding of clinical data.
Exceptional writing skills.
Excellent organizational skills and ability to multi‑task.
Proficiency 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.
Seniority Level Mid‑Senior level
Employment Type Part‑time
Job Function Marketing, Public Relations, and Writing/Editing
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