Rowell M.

Director, Promotional Regulatory Affairs - Oncology/Hematology @ AstraZeneca

About

Career highlights:- Promotional Regulatory Affairs (PRA) Lead for 7 US launches and Labeling Strategy Lead for 4 US supplement approvals across 4 oncology/hematology brands- Created 2 AstraZeneca fellowship programs: One in Labeling Strategy and the other in PRA- Reviewed the patient product labeling for over 90 New Drug Applications, Biologics License Applications or Investigation New Drugs at FDA- Developed standard operating procedures and outlined responsibilities for a newly created position, Intake Pharmacist, to maximize the new patient referral process at Johns Hopkins Home Care GroupSkills:- Developing strong professional relationships by promoting teamwork, trust and accountability- Delivering value-added solutions- Adapting to new environments, including in the clinical, health authority (FDA) and industry settings- Strong organizational, communication and analytical skills in order to be successful in a fast-paced and dynamic environmentSummary: Dedicated and motivated promotional regulatory affairs lead with clinical expertise (PharmD and board certification in pharmacotherapy- BCPS) and experience in regulatory advertising/promotion and labeling strategy.

Country

United States

City

Washington DC-Baltimore Area

Industry

Pharmaceuticals

Skill

Clinical Research, Home Infusion, Oncology, Medical Writing, Teaching, Medical Information, Pediatrics, Patient Safety

Experience

Director, Promotional Regulatory Affairs - Oncology/Hematology

AstraZeneca

2023-4 - Present · 3 yrs 6 mos

Associate Director, Promotional Regulatory Affairs - Oncology/Hematology

AstraZeneca

2019-9 - 2023-4 · 3 yrs 8 mos

Gaithersburg, Maryland

Promotional Regulatory Affairs Lead for several new indication launches for multiple AstraZeneca brands in oncology/hematology, as well as unbranded disease awareness campaigns Experience in working collaboratively on alliance products with partner companies Integral for initiating AstraZeneca’s first PharmD fellowship program in Promotional Regulatory Affairs by creating a development learning plan, preparing a budget, leading recruitment activities and serving as Primary Preceptor

Associate Director, Global Labeling Strategy - Oncology/Hematology

AstraZeneca

2017-4 - 2019-8 · 2 yrs 5 mos

Gaithersburg, Maryland

Global Excellence Award Winner for Team of the Year in 2018 for contributions, including US approval of a new AZ product Led and executed the global labeling strategy within the therapeutic areas of immuno-oncology, hematology and respiratory by driving the development of the company Core Data Sheet (CDS), US Prescribing Information and EU Summary of Product Characteristics Integral for initiating AstraZeneca’s first PharmD fellowship program in Global Labeling Strategy by creating a development learning plan, preparing a budget, leading recruitment activities and serving as Primary Preceptor

Labeling Reviewer

FDA

2015-7 - 2017-4 · 1 yr 10 mos

Silver Spring, MD

Reviewed the Medication Guides, Patient Package Inserts, Instructions for Use leaflets and other patient product information

Clinical Infusion Pharmacy Specialist

Johns Hopkins Hospital

2011-7 - 2015-7 · 4 yrs 1 mo

Baltimore, MD

Provided clinical monitoring, patient assessments and therapy management for the pediatric team of 110-130 home infusion patients within the therapeutic areas of infectious disease, gastroenterology, oncology/hematology, transplant, immunology, pulmonology, cardiology and rheumatology Assessed new patients for home infusion therapy based on clinical, operational and financial information to ensure each patient is suitable for home care in accordance to company policies