Senior Medical Writer (Remote)

About the company

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 assist clients in developing and marketing life-changing therapies to positively improve lives worldwide.

MMS recognizes that a talented staff drives business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger.

Responsibilities

• 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 good internal and external customer service.
• Demonstrate highly proficient writing styles for various regulatory documents and expert proficiency with client templates and style guides.
• Interact directly and independently with clients to coordinate all facets of projects; serve as a competent communicator for projects.
• Contribute substantially to, or manage, the production of interpretive guides.
• Take ownership of assignments, proactively consulting other project team members and department representatives for information or guidance as necessary.
• Mentor medical writers and other project team members involved in the writing process.

Requirements

• At least 3 years of previous experience in the pharmaceutical industry.
• At least 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 (ideal candidate).
• 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 (a must).
• Excellent organizational skills and the ability to multi-task (essential).
• Expert proficiency in MS Word, Excel, PowerPoint, and related word-processing tools.
• Experience as a project lead or managing a project team.
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines (a plus).
• Experience with orphan drug designations and PSP/PIPs (not required but a plus).