Regulatory Affairs Manager

Profile

An Indiana University School of Nursing graduate with 15 years experience in the

pharmaceutical industry, ranging from clinical development/research to Medical and Regulatory Affairs, with a focus on Advertising and Promotion.

REGULATORY AFFAIRS MANAGER-ADVERTISING/PROMOTION, ELI LILLY AND COMPANY 2012-2018

Contributed regulatory counsel to brand teams across 3 therapeutic areas (Immunology, Diabetes, Oncology); including launch experience on an immunology growth product with a robust consumer campaign and a diabetes drug/device combo. Created positive customer experiences by engaging with the Office of Prescription Drug Promotion (OPDP), in coordination with internal business partners, to deliver compliant and timely regulatory assessments on advertising and promotion tactics.

MEDICAL INFORMATION ASSOCIATE MANAGER, ELI LILLY AND COMPANY 2006-2012

Provided medical affairs support for Cymbalta (duloxetine), a multi-billion dollar drug; including medical writing, key opinion leader engagement, sales representative training, faculty training, call center support, scientific/medical congress support, and marketing/brand team collaboration; with launch experience in generalized anxiety disorder, fibromyalgia, and chronic musculoskeletal pain.

CLINICAL RESEARCH NURSE, ELI LILLY & COMPANY 2002-2006

Implemented and coordinated Phase I clinical protocols at an inpatient/outpatient clinical research unit. Collaborated with Sponsor, vendors, CROs, and other site personnel to effectively and efficiently drive protocol from enrollment to datalock. STAFF NURSE II,

WISHARD HEALTH SERVICES - 1998-2002

Emergency Room nurse at a Level I trauma center with responsibilities ranging from patient care to charge nurse.

Education

Indiana University-Bloomington Bachelor of Science in Nursing, 1999 Skills

Solution-oriented cooperative thinking; time and resource management; multi-tasking; negotiation skills; navigating highly regulated environments; attention to detail; the ability to influence without authority; decision making in the midst of ambiguity; knowledge of drug development; cross-functional communication and collaboration; critical-thinking skills; intelligent risk taking; strong interpersonal, communication, and leadership skills References

Available upon request

Michael J. Adams RN, BSN

317-***-**** **********@*****.*** 422 Wallace Ave, Indianapolis, IN 46201

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