Developed and managed the scientific communications team responsible for overseeing all abstracts, posters and manuscripts created within the division as well as the physician-initiated study proposal process. Key accomplishments include:• Created and implemented publication plan and process for all neuromodulation scientific programs• Established the division publication policy • Strategic alignment of neuromodulation publication plan with business initiatives• Significantly increased the number of published manuscripts created within the division year over year• Attended and presented data at scientific/medical conferences to establish SJM as a leader in neuromodulation-related clinical research• Developed current process for sponsorship and review of physician-initiated study proposals

Responsible for leading a team of clinical research scientists with diverse responsibilities including clinical research representation on product development teams, preclinical research development, implementation and management, clinical research protocol development, assimilating medical information to key opinion leaders and other healthcare professionals in the role of clinical science liaison, scientific/medical communications including development of publication strategies, drafting and submitting abstracts, posters, and manuscripts in as well as presenting research study findings at national conferences.

Served as clinical research representative on product development teams. Developed, implemented and managed preclinical research projects. Provided input into design and appropriate outcome measures for clinical research protocols for both pre- and post-market studies. Assimilated scientific/medical information to key opinion leaders and other healthcare professionals. Drafting and submitted abstracts, posters, and manuscripts. Presented research study findings at national conferences. Performed literature reviews for regulatory submissions and internal guidance. Wrote reports for regulatory submissions for product approval. Worked with healthcare professionals on the development of study ideas and clinical research protocols. Reviewed physician-initiated study proposals to determine the feasibility and importance of the proposed research.

Planned, organized and coordinated clinical studies. Identified, selected, initiated and closed-out appropriate study sites for clinical studies. Created all study related documents including clinical study protocols, clinical final reports, informed consents, case report forms, and other documents. Performed investigator training, site audits, and reports progress of the clinical studies. Assured study compliance to study protocol, domestic and international good clinical practices (GCPs) guidelines and standard operating procedures (SOPs). Developed assigned investigational plans (including clinical protocol, case report forms, and all required documents). Trained clinical site personnel and investigators. Assured study compliance and that all safety information was reported appropriately. Maintained communication with sites. Presented clinical study updates and summaries in written and oral reports. Monitored (initiation, periodic and close-out visits) all clinical studies according to written GCPs and SOPs.