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 mission. Enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger.

Responsibilities

• Critically evaluate, analyze, and interpret 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).