Medical Writer for Clinical Development Documents
2 settimane fa
Job Title: Senior Medical Writing Consultant
About Us: MMS Holdings Inc 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. We have a global footprint across four continents and maintain a 97 percent customer satisfaction rating.
Job Description:
We are looking for a full-time Senior Medical Writing Consultant to join our extended team. As a Senior Medical Writing Consultant, you will 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. You will write and edit clinical development documents, including clinical protocols, investigator's brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, presentation materials, and publications to medical journals. You will also maintain timelines and workflow of writing assignments, practice good internal and external customer service, and interact directly and independently with clients to coordinate all facets of projects.
Requirements:
At least 3 years of previous experience in the pharmaceutical industry. Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience. The ideal candidate would hold a Bachelor's, Master's, or Ph.D. in a scientific, medical, or clinical discipline. Substantial clinical study protocol experience, as lead author, is required. Experience leading and managing teams while authoring regulatory documents with aggressive timelines is also required. Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines is a plus.
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