Drmarbys is hiring: Principal Medical Writer in Charleston
Drmarbys, Charleston, SC, United States, 29408
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 the company has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for the last three consecutive years. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.
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.
- Highly proficient in writing styles for various regulatory documents and expert proficiency with client templates & style guides.
- Interact directly and independently with clients to coordinate all facets of projects; possess competent communication skills 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 members of the project team involved in the writing process.
Requirements
- Bachelor’s, Master’s, or PhD Degree in scientific, medical, clinical discipline or related field is required with at least 6 years of previous regulatory writing experience; Master’s or PhD degree is preferred.
- Substantial clinical study protocol experience as lead author is required.
- Experience leading and managing teams while authoring regulatory documents with aggressive timelines.
- Experience in regulatory submissions (clinical study reports) presented to regulatory authorities is a plus.
- Understanding of clinical data is essential.
- Exceptional writing skills are a must.
- Excellent organizational skills and the ability to multi-task are essential prerequisites.
- Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools.
- Experience being a project lead or managing a project team is preferred.
- Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines is a plus.
- Experience with orphan drug designations and PSP/PIPs is not required but a plus.
Seniority Level
Mid-Senior level
Employment Type
Full-time
Job Function
Marketing, Public Relations, and Writing/Editing
Industries
Smart Meter Manufacturing
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