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Medical Writer Consultant - 12 Month Contract

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Job Description: Northern Jersey Medical Writer Consultant - 12 month contract send resume along with references to K3-Innovations ( is looking for a Medical Writer Consultant for a Global Pharmaceutical company located in Bergen County, NJ. Than Medical Writer must come out of a global pharma having experience with creating regulatory documents. The Medical Writer will work directly with clinical study teams, the Oncology medical writing teams, regulatory affairs personnel, and the publishing group in the preparation of scientifically valid regulatory documents. Working remotely is a possibility 2 days per week, however, initially candidates must be willing and able to commute on site 5 days (Northern NJ). Responsibilities include: Prepare regulatory documents in accordance with the ICH guidelines, international regulations, standards and processes, and the companys Writing Style Guide as applicable. Documents include but are not limited to: Protocols and protocol amendments, clinical study reports, Investigator brochures, and submission documents. Participate in project team meetings to provide input regarding deliverables, timelines, and processes. Responsible for managing the document review process. Route documents for approval. The medical writer should be familiar with ICH guidelines and the current AMA Style Manual. The writer will be expected to format and manage long documents with multiple review cycles and tight deadlines. Qualifications: Bachelor's degree in Life Sciences, RN, Master's degree in Life Sciences, PharmD or PhD preferred. Would prefer full time onsite 5 days a week, however we will accept someone to work remotely but must work 3 days minimum onsite. Excellent writing skills, meticulous attention to detail, proficiency using an electronic document management system, and strong analytical ability to interpret clinical data. 5+ years writing experience in the pharmaceutical industry. Experience working as a MW at a major Pharma. Prior experience in oncology is required. The most important requirement is the ability to independently write regulatory documents in collaboration with the various members of study team. Please take note this is a FULL time 40 hour work week.

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