Senior Associate, Clinical Pharmacology Scientific Support & Reporting Writing

Job description

To build all necessary data/information needed in preparing internal documents/scientific reports related to clinical trials and; to keep multiple reports moving forward simultaneously through multi-tasking. Responsibilities Prepare scientific reports and presentations related to clinical trials using available software and templates. Assists in constructing phase 1 clinical study planning documents, and writes Phase 1 protocols. Review clinical protocols and key decisions impacting project timelines with management. Comply with procedures set forth in relevant IQS documents and Study protocols and other directives issued by the management regarding clinical/ preclinical studies. Apply experience to analyze clinical study data, including statistical data using available software to assist with ongoing blinded efficacy and safety reviews and ensure the scientific integrity of all processes. Responsible for receiving and completing tasks and assignments from Therapeutic Area MD or Scientific Staff within timeline with minimal supervision Ensure scientific integrity of all processes by applying current electronic document conventions and processes consistently and accurately. Integrate clinical trial data across studies and identify issues impacting projects and provide this information to internal peers and therapeutic area management. Perform literature/competitive intelligence searches to recognize/resolve scientific and technical problems by applying the most current electronic document conventions and processes consistently and accurately. Participate on teams for process improvement initiatives and review key decisions impacting project timelines with management. Responsible for maximizing individual, therapeutic area and team productivity; and mentor therapeutic area personnel. Bachelors/Master’s degree, in Science related to Field with +7 years’ experience in pharmaceutical industry Understanding of clinical study principles Must possess good oral and written communication skills Must be proficient in using computer to analyze clinical study data, generate reports and create presentations, posters and manuscripts Must have knowledge of complex scientific analyses, business-related procedures, and project leadership. Experience supporting clinical research, drug development and/or therapeutic area operations. Must have a proven record of successful projects. Ability to produce work of the highest quality by paying attention to detail Ability to appropriately and effectively use resources to complete tasks and meet required timelines. Independent expertise/experience to analyze clinical study/statistical data by using available software.