Senior Medical Writer (Protocols) - Remote

Job Description

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. 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 or follow MMS on LinkedIn.

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, mostly focusing on clinical protocols but the overall role may include, but is not limited to, 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 and 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

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

The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline

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

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

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