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regulatory compliance coordinator resume example with 9+ years of experience

Jessica
Claire
resumesample@example.com
(555) 432-1000,
, , 100 Montgomery St. 10th Floor
:
Summary

Highly motivated regulatory Compliance Coordinator with 4.5 years of experience in the pharmacy retail business. Focus on quality compliance in pharmacy and manage all regulation of HIPAA and FDA. Experience in principal regulatory compliance department, regulatory team and expertise in supporting the regulatory aspects of controlled and uncontrolled medicines. Coordinating and participating in on-site, virtual, and paper audits as required by regulatory bodies. Worked on health care standards such as HIPAA, ICD-9, ICD-10. Support of a Just medication safety culture within pharmacy department. Working collaboratively with pharmacist , organizational departments and managers to plan, coordinate and implement compliance improvement projects and programs. Regulatory affairs student pursuing my master's degree from Northeastern University with background in Regulatory compliance and seeks an opportunity to gain experience in Regulatory affairs. Outgoing and friendly with strong motivation for success.

Skills
  • Excellent Decision-making
  • Team communication
  • Data analytics
  • Quality Management
  • Decision making
  • Innovation
  • Leadership
  • New product development
  • Organizational
  • Policies
  • Problem solving
  • Project planning
Education and Training
Gujarat Technological University , Expected in 2012 Bachelor of Science : Pharmacy - GPA :
Northeastern University Boston, MA Expected in 04/2023 Master of Science : Regulatory Affairs - GPA :
Experience
Hca - Regulatory Compliance Coordinator
Ks, KS, 07/2017 - Current
  • Regulatory Compliance & Coordinator is responsible for leading the pharmacy departments, regulatory compliance program and for assisting the Medication Safety Officer with medication safety initiatives.
  • Responsibilities include: Leading and coordinating pharmacy and medication related regulatory compliance efforts across the Representing pharmacy on compliance committees.
  • Evaluating and ensuring compliance of organizational policies with applicable state and federal laws, rules & regulations , including but not limited to those of The Joint Commission (TJC), Centers for Medicare & Medicaid Services (CMS), and the Florida Department of Health & Human Services (FHHS).
  • Coordinating and participating in on-site, virtual, and paper audits as required by regulatory bodies.
  • Coordinating creation and updates of Department of Pharmacy policies & procedures, and HIPAA polices.
  • Providing assistance with internal audit reviews as requested.
  • Supporting efforts of Medication Safety Officer as assigned to promote a safe medication use system.
  • Take part in innovation, creativity and decision making and problem solving process.
Alector, Inc. - Regulatory Affairs Associate
Newark, CA, 02/2016 - 05/2017
  • Providing Regulatory advice and support to internal and external customers from development through full life cycle management.
  • Be willing to work with a Lean team and wear multiple hats to create smart strategies for regulatory submissions and an expanding Quality Management System.
  • Provide regulatory leadership for new product development and change management activities.
  • Coordinate/manage the review and approval process of senior management of the company for all regulatory submissions on company development compounds Participates in activities to create and improve regulatory processes and systems Establishes confidence in one’s regulatory abilities and develops long-term trusting relationships Provide technical customer assistance.
Harris Computer Systems - Territory Marketing Manager
White Plains, NY, 03/2015 - 01/2016
  • Is responsible for manages the day to day marketing activities of the organization and long term marketing strategy for the company.
  • Responsibilities included: Get daily, weekly, monthly, quarterly reports of all medical representatives.
  • Planning & Execute Monthly or Quarterly Targets.
  • Arranging appointments to targeted customers.
  • Exploring new territories.
  • Customer Relationship Builder.
  • Recommends changes in products, service, and policy by evaluating results and competitive developments.
  • Resolves customer complaints by investigating problems; developing solutions; preparing reports; making recommendations to management.
  • Provide significant input into the annual marketing plan, specifically: sales forecasts for each product (taking into consideration past history, market trends, competitive activity and required sales effort), allocation of expenses between products (taking into consideration stage in product life cycle, potential for future growth and profit contribution, potential competitors), required sales promotion programs (taking into consideration marketing strengths relative to competitors, selling opportunities and customers needs and attitudes) and the marketing materials needed to accomplish the goals.
  • Building Brand.
Ahmc Healthcare Inc. - Marketing Executive
Daly City, CA, 06/2013 - 02/2015
  • Marketing executive is responsible for manages the day to day marketing activities of the organization and long term marketing strategy for the company.
  • Responsibilities included: Get Appointment with Doctors, Pharmacists and wholesalers.
  • Educate Doctors and Pharmacists about our products.
  • Obtain orders and reach monthly and quarterly targets.
  • Keep in touch with management by submitting daily activities & call reports.
  • Monitoring competitor's brand, analyzing price, marketing scheme & Promotions.
  • Get orders from medical stores and monitor stocks from wholesale.
  • Submit sales and stock data.
ARAV PHARMACY - Pharmacist
City, STATE, 10/2012 - 05/2013
  • Providing advice about health issue, symptoms & medication in response to customer inquiries.
  • Ordering, Selling & Controlling medicines & other stocks under supervision of Pharmacist.
  • Meeting Medical representative of Company.
  • Managing Budget.
  • Keeping Statistical & Financial Record.
  • Organize products in proper manner.
  • Maintain the hygienic environment in Store.

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Resume Overview

School Attended

  • Gujarat Technological University
  • Northeastern University

Job Titles Held:

  • Regulatory Compliance Coordinator
  • Regulatory Affairs Associate
  • Territory Marketing Manager
  • Marketing Executive
  • Pharmacist

Degrees

  • Bachelor of Science
  • Master of Science

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