Medical Writer - Research - Limited Tenure (1 Year)

This is a limited tenure position that has been approved for 1 year that may have the possibility of turning into a regular position. 

Responsibilities include researching, writing and editing clinical research protocols. This includes specific research reports, manuscripts, patient information and documentation required by Mayo and external sponsors/agencies. The position must demonstrate effective collaboration and communication, utilizing participative decision-making when appropriate. Position coordinates and provides overall management of the protocol document from initial concept through study completion, termination and publication. Responsibilities include, but are not limited to: ongoing management of the protocol document and process through editing, proofing, coordination of study logistics, (i.e. blood collection kits, data collection booklets, etc) and verification of content to meet institutional and federal standards; communicating with study sites and/or federal agencies; ensuring Mayo standards are adhered to; and ensuring appropriate approvals have been obtained. The individual will accurately apply investigator's scientific data into a cohesive format for the protocol document while ensuring applicable procedures are consistent with internal and external policies and regulatory requirements. The individual will independently maintain and oversee all collaborative functions between the unit/department and its customers. The Research Medical Writer is an active member on committees and task forces and participates on projects as assigned. The individual is responsible for writing and implementing applicable standard operating procedures and working instructions for the department/unit and will ensure compliance with regulatory and other compliance standards, both internal and external. The individual will act as a liaison with external agencies and various internal departments/divisions. They will develop and carry out staff training and mentoring as necessary. In addition, the individual will participate in other protocol development activities and execute other assignments as warranted and assigned.

• Master's degree preferred. A bachelor's degree (BA, BS) is required, preferably in the field of bio-medical science, lab or nursing. 
• Requires experience with medical terminology with a minimum of 5 years' experience in a medical or complex administrative setting required. 
• Previous research/education background with IRB and/or a regulatory/legal environment preferred. 
• Medical writing, data management, comprehension of complex structures, continuous improvement and project management skills are preferred. 
• Must possess exceptional interpersonal, written and oral communication skills. 
• Required to maintain confidentiality of information, demonstrate good decision-making and judgment and have attention to detail and follow-through skills. 
• Must be willing to adapt within a rapidly changing environment. 
• Must be able to manage multiple projects in a deadline-driven environment and exercise appropriate judgment and organizational skills when prioritizing projects and tasks. 
• Must have the ability to work independently in ambiguous situations under pressure and have strong coping skills. 
• Must be dependable, self-directed and able to take the initiative to organize and direct personnel in the various aspects of research studies. 
• Must be proficient in the use of computers, Microsoft applications and databases. 
• Must have demonstrated analytical and problem-solving skills and have the ability to effectively and independently manage a large workload with minimal supervision.

Visa sponsorship is not available for this position.  This position is not eligible for F-1 OPT STEM extension.

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