Senior Medical Writing Consultant
2 giorni fa
MMS Holdings Inc. is a leading Contract Research Organization (CRO) that provides innovative data-focused services to the pharmaceutical, biotech, and medical device industries. We are seeking a highly skilled Senior Medical Writing Consultant to join our team.
The ideal candidate will have a strong background in regulatory writing and clinical medical writing, with experience in leading and managing teams while authoring regulatory documents with aggressive timelines. The successful candidate will be responsible for critically evaluating, analyzing, and interpreting the medical literature to select primary resource materials for clinical development documents.
Key Responsibilities:
- Critically evaluate, analyze, and interpret the medical literature to select primary resource materials for clinical development documents.
- Write and edit clinical development documents, including clinical protocols, investigator's brochures, clinical study reports, subject consent forms, and integrated safety and efficacy summaries.
- Complete writing assignments in a timely manner and 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.
- Contribute substantially to the production of interpretive guides and mentor medical writers and other members of the project team.
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 essential.
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