Associate Scientist II
Lake Bluff, IL 60044 US
• Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. Interacts with regulatory agencies as needed and will use scientific and medical knowledge to write strategic responses to questions from regulatory bodies about submissions.
• Participates in the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/direction.
• Interacts with various study support groups cross-functional teams to assist in clinical strategy, the development of plans, reports and project deliverables. Is responsible for providing clinical feedback for other cross-functional deliverables.
• Facilitates communication between Sales and Marketing, R&D, Clinical R&D, Regulatory Affairs, Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs or Clinical Science, Clinical Project Management, external CROs or Medical Writers, Training, Senior Management and investigational sites as directed by your manager.
• Conducts team meetings, drafting and sending routine correspondence (e.g., timelines, meeting minutes) and/or by giving presentations to senior staff on project status. Creates, manages, or participates in clinical study or clinical evaluation timelines.
*CO/NYC candidates might not be considered
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