Senior Medical Writer (Remote)

Mediabistro; Miami (FL); Remote; USD 70,000 - 90,000; Full time

Job summary

A leading contract research organization is seeking a Medical Writer to join their team in Miami, Florida. The ideal candidate will have at least 3 years of experience in the pharmaceutical industry, with a focus on regulatory and medical writing. Responsibilities include writing clinical development documents and mentoring team members. The position offers an opportunity to work on diverse projects with a global impact.

Qualifications

• At least 3 years of experience in the pharmaceutical industry.
• Experience leading clinical study protocols as the lead author.
• Knowledge of federal regulations, GCP, and ICH guidelines.

Responsibilities

• Critically evaluate and interpret medical literature.
• Write and edit clinical development documents.
• Mentor medical writers and project team members.

Skills

Medical writing

Regulatory submissions

Strong writing skills

Organizational skills

Team management

Education

Bachelor’s, Master’s, or Ph.D. in a scientific or medical discipline

Tools

MS Word

Excel

PowerPoint

Job description

About MMS MMS is an innovative, data-focused CRO supporting the pharmaceutical, biotech, and medical device industries with a scientific approach to complex trial data and regulatory submissions. With a global presence across four continents, MMS maintains a 97% customer satisfaction rating. Our mission is to deliver high-quality service and technology solutions rooted in science and regulatory expertise to help our clients develop and market life-changing therapies worldwide. MMS values talented staff as the key to our success. We prioritize attracting top talent, providing ongoing training, and fostering enthusiasm, collaboration, and teamwork. We believe a diverse, global talent pool makes us stronger. For more information, visit

www.mmsholdings.com

or follow MMS on LinkedIn. Responsibilities

Under minimal supervision, critically evaluate and interpret medical literature to select primary resources for study design, statistical significance, scientific rigor, and bias assessment. Write and edit clinical development documents, including protocols, investigator’s brochures, clinical study reports, consent forms, safety and efficacy summaries, Module 2.7.1-4, 2.5 documents, presentations, and journal publications. Complete writing assignments timely, maintain workflows, and ensure quality standards. Practice excellent customer service internally and externally. Proficiently use styles for various regulatory documents, client templates, and style guides. Interact independently with clients to coordinate project aspects, demonstrating strong communication skills. Contribute to or manage the production of interpretive guides. Take ownership of assignments, consulting with team members and departments as needed. Mentor medical writers and project team members involved in writing processes. Requirements

At least 3 years of experience in the pharmaceutical industry, with 3-5 years in regulatory and medical writing. Bachelor’s, Master’s, or Ph.D. in a scientific or medical discipline. Experience leading clinical study protocols as the lead author. Experience managing teams and authoring regulatory documents under tight deadlines. Experience with regulatory submissions, especially clinical study reports, is a plus. Understanding of clinical data and exceptional writing skills. Strong organizational skills and ability to multitask. Expertise in MS Word, Excel, PowerPoint, and related tools. Experience as a project lead or managing project teams. Knowledge of federal regulations, GCP, and ICH guidelines is advantageous. Experience with orphan drug designations, PSPs, or PIPs is a plus. This job posting does not indicate that it is expired.

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