Drmarbys is hiring: Principal Medical Writer in Charleston

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

1. 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.
2. 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.
3. Complete writing assignments in a timely manner and maintain timelines and workflow of writing assignments.
4. Practice good internal and external customer service.
5. Highly proficient in writing styles for various regulatory documents and expert proficiency with client templates & style guides.
6. Interact directly and independently with clients to coordinate all facets of projects; possess competent communication skills for projects.
7. Contribute substantially to or manage the production of interpretive guides.
8. Take ownership of assignments, proactively consulting other project team members and department representatives for information or guidance as necessary.
9. Mentor medical writers and other members of the project team involved in the writing process.

Requirements

1. 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.
2. Substantial clinical study protocol experience as lead author is required.
3. Experience leading and managing teams while authoring regulatory documents with aggressive timelines.
4. Experience in regulatory submissions (clinical study reports) presented to regulatory authorities is a plus.
5. Understanding of clinical data is essential.
6. Exceptional writing skills are a must.
7. Excellent organizational skills and the ability to multi-task are essential prerequisites.
8. Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools.
9. Experience being a project lead or managing a project team is preferred.
10. Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines is a plus.
11. 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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