***** **** ******* *** ****, Potomac, MD *****·301-***-****·ac8ebz@r.postjobfree.com

Priyanka Kumar, Pharm D, MBA, PMP

Objective

Develop and implement new projects and enhance program development to deliver company goals and mission to the public.

Areas of Expertise

Project Management

Tactical Strategic Planning

Team Leadership

Solution-Focused

Improving Customer Satisfaction

Training/Presentations

MS Project

Event Planner

Organization

Culinary Skills in Baking and Cake Decorating

Experience

September 2018- Current: Office of Pharmaceutical Quality OPQ/CDER/FDA

Food Drug Administration

10903 New Hampshire Ave, Bldg. 75 Silver Spring, MD 20993

Regulatory Health Project Manager

Facilitate and manage the review of New Drug Applications as well as Investigational Drug Applications

Lead and Conduct Planning for Advisory Committee Meetings

Manage Sponsor Meetings between Agency and Industry

Serve as a Liaison between the Division and Industry

Develop and drive project timelines

Schedule routine meetings with team members

40 Hour per week

April 2016-September 2018 Division of Anesthesia, Analgesia, and Addiction Products OND/CDER/FDA

Food Drug Administration

10903 New Hampshire Ave, Bldg. 22 Silver Spring, MD 20993

Regulatory Health Project Manager

Facilitate and manage the review of New Drug Applications as well as Investigational Drug Applications

Lead and Conduct Planning for Advisory Committee Meetings

Manage Sponsor Meetings between Agency and Industry

Manage Labeling Reviews for Drug Applications Involved in Safety Labeling Changes for Opioid & Addiction Products

Serve as a Liaison between the Division and Industry

Develop and drive project timelines

Schedule routine meetings with team members

40 Hour per week

January 2015-April 2016 Office of Surveillance Immediate Office OPQ/CDER/FDA

Food Drug Administration

10903 New Hampshire Ave, Bldg., 51 Silver Spring, MD 20993

Regulatory Health Project Manager

Lead and implement new office procedures and projects.

Developing SOPs for Divisions within the office.

Facilitate duties and tasks for the New Inspection Protocol Project.

Develop and drive project timelines.

Monitor business processes, and promote development and implementation of on-going process.

Coordinates with team members from both Divisions within the office to ensure on time completion and conformance to internal processes and procedures.

40 hours per week

February 2013- January 2015 Office of New Drugs Quality Assessment OPS/CDER/FDA

Food Drug Administration

10903 New Hampshire Ave Bldg. 21, Silver Spring, MD 20993

Regulatory Health Project Manager

Served as a co-leader of the CMC review team with the Scientific Co-Leader.

Managed the CMC Drug Review process for one or more classes of drugs from initial submission to time of approval, termination or withdrawal.

Assured timely resolution of scientific and regulatory conflicts to avoid delays in achieving goals.

Driving force for completion of project activities and objectives.

Lead Face to Face meetings between Industry and the Agency.

Served as a liaison between the chemistry reviewers, Office of Compliance and the Office of New Drugs.

40 hours per week

November 2010-Current CVS/Pharmacy

10233 Old Georgetown Rd, Bethesda, MD 20814

Registered Staff-Pharmacist

Pharmacy Team Leader

Work in a high prescription volume setting

Oversee all the pharmacy technicians and their duties

Analyze data related directly towards prescription business

Between the Nov 2010-Feb 2013 40 hours per week

Between Feb 2013 and now, average 15-20 hours per week

November 2013-Current Event Planner and Dessert Table Decorator

Self-Business Owner

Experience in Planning and Decorating Events for 100 + guest

Coordinate activities and different elements to the event

Decorate Dessert Tables as well as Venue

Possess skills in baking and cake decorating

Provide customers with Fondant cakes, cupcakes, and other dessert treats

Education

2014-2018 University of Maryland University College

1616 McCormick Dr. Upper Marlboro, MD 20774

Degree Obtained: Master of Business Administration

2006-2010 Bernard J. Dunn School of Pharmacy

1775 North Sector Court

Winchester, VA 22601

Doctorate of Pharmacy

2004-2006 University of Maryland, College Park

7999 Regents Dr.

College Park, MD 20742

Pre-Pharmacy work

Awards/Training/Certificate

2018

Masters in Business Administration (MBA)

Project Management Professional (PMP) -Certificate received February 14. 2018

2017

FDA's Opioid Action Plan Implementation Team- Center Director's Special Citation

2016

Masters Certificate in Project Management, George Washington School of Business

Leveraging Collaboration Award- Office of Pharmaceutical Quality

2015

Transition Hero Award-Office of Pharmaceutical Quality

2014

FDA Pharmacy Experiential Program Mentor

Team Excellence Award-Pilot Program for Microbiology Quality Review of Original New Drug Applications.

References

Available Upon Request

Contact this candidate