Our Direct Client is looking for a Senior Medical Writer for a pharmaceutical client in New Jersey. Work directly with our client's clinical study teams, the Oncology medical writing teams, regulatory affairs personnel, and the publishing group in the preparation of scientifically valid regulatory documents. Responsibilities include prepare regulatory documents on behalf of our client in accordance to ICH guidelines, international regulations, client standards and processes, and the client's Writing Style Guide as applicable. Documents include but are not limited to: Protocols and protocol amendments, clinical study reports, addenda, errata. Investigator brochures, new drug advisory submission documents. Participate in clinical study and project team meetings to provide input regarding deliverables, timelines, and processes needed. Administer the receipt, collation, and incorporation of review documents. Route documents for approval. The medical writer should be familiar with ICH guidelines and the AMA Manual of Style, 10th edition. The writer will be asked to format and manage long documents with multiple review cycles and tight deadlines. Qualifications: Excellent writer, good organizational and communication skills. Strong attention to detail. Proficiency using eDMS. Strong analytical ability to interpret clinical data. 7 years writing experience in the pharma industry. Bachelor's degree in life sciences, RN, Master's degree in life sciences, PharmD or MD preferred. Can work remotely but must work 2 days min onsite. Excellent writing skills, compulsive attention to detail, proficiency using an electronic document management system, and strong analytical ability to interpret clinical data. Experience: 7 years writing experience in the pharmaceutical industry.. A copyediting test will be required during the interview Bachelor's degree in life sciences, RN, Master's degree in life sciences, PharmD or MD preferred. Candidate can work remotely but must work 2 days minimum onsite. Excellent writing skills with compulsive attention to detail.
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