Join to apply for the Principal Medical Writer role at DRM Arby's.
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 has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for the last three consecutive years.
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, and presentation materials.
- Complete writing assignments in a timely manner and maintain timelines and workflow of writing assignments.
- Practice good internal and external customer service.
- Interact directly and independently with clients to coordinate all facets of projects.
- Mentor medical writers and other members of the project team involved in the writing process.
Requirements
- Bachelor’s, Masters, or PhD Degree in scientific, medical, clinical discipline, or related field is required with at least 6 years of previous regulatory writing experience; Masters or PhD degree is preferred.
- Substantial clinical study protocol experience as lead author required.
- Experience leading and managing teams while authoring regulatory documents with aggressive timelines.
- Exceptional writing and organizational skills are a must.
- Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools.
- Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines is a plus.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Marketing, Public Relations, and Writing/Editing
Industries
Smart Meter Manufacturing
#J-18808-Ljbffr