Senior Medical Writer; Remote

Overview

Senior Medical Writer (Remote) at MMS.

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About MMS: MMS is a data-focused CRO that supports 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 assist clients in developing and marketing life-changing therapies.

MMS emphasizes enthusiasm, collaboration, and teamwork within a global, diverse talent pool.

For more information, visit  or follow MMS on Linked In.

• 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 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 and maintain timelines and workflow of writing assignments.
• Practice excellent internal and external customer service.
• Demonstrate proficiency with writing styles for various regulatory documents and with client templates and style guides.
• Interact directly and independently with clients to coordinate all facets of projects; communicate effectively for project needs.
• Contribute substantially to, or manage, production of interpretive guides.
• Take ownership of assignments, proactively consulting team members and other department representatives as needed.
• Mentor medical writers and other project team members involved in the writing process.

• At least 3 years of experience in the pharmaceutical industry; 3–5 years of regulatory and clinical medical writing experience preferred.
• Educational background:
  Bachelor’s, Master’s, or Ph.D. in scientific, medical, or clinical discipline.
• Extensive experience with clinical study protocols as lead author.
• Experience leading and managing teams while authoring regulatory documents with aggressive timelines.
• Experience in regulatory submissions (clinical study reports) is a plus.
• Strong understanding of clinical data; exceptional writing skills; excellent organizational and multi-tasking abilities.
• Expert in Microsoft Word, Excel, PowerPoint, and related tools; project lead or team management experience.
• Knowledge of federal regulations, Good Clinical Practices, and ICH guidelines is a plus; experience with orphan drug designations and PSP/PIPs is a plus.

• Mid-Senior level

• Full-time

• Marketing, Public Relations, and Writing/Editing

• Pharmaceutical Manufacturing

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