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Customer Service Regulatory Affairs

Location:
Dallas, TX
Posted:
June 29, 2023

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Resume:

JACKLYNNE K. KAMAU Pharm. D

**** ******** ***** #***, *** Antonio, TX 78240

210-***-**** · adxzwi@r.postjobfree.com

RETAIL SPECIALIST/CONSULTANT

Profile Summary

Retail Pharmacist and Pharmacy Manager of fast paced (over 1000 scripts a day) pharmacies in Texas.

Retail pharmacy district supervision of up to 30 stores in San Antonio, Texas

Proven modelling and sharing of customer service best practices

Recognized for Inventory Control Excellence in a fast paced retail pharmacy setting

Experienced in Regulatory Affairs, Quality Assurance and Pharmacovigilance documentation and compliance.

Registered pharmaceutical products in Kenya with Pharmacy and Poison Board (PPB.)

Well versed in Kenyan and East Africa Community Regulatory Affairs Law regulated by PPB and EAC Joint Commission respectively

Worked with the regulator in compliance audits, document submissions and issuance of import permits.

Registered as a pharmacist by Kenya Pharmacy and Poisons Board

Registered as a pharmacist, diabetic educator and immunizer with the Texas State Board of Pharmacy

Proven experience in pharmaceutical marketing and distribution.

Extensively collaborated with Kenya Association of Pharmaceutical Importers (KAPI.)

Professional Experience

Pharmacy Manager Walgreens in San Antonio TX 2003-2010

Manage an inventory valued at USD 1 million daily to promote sales and enhance stocking.

Instituted systems that enhanced the stores audit records to outstanding.

Increase pharmacy sales by 20% by partnering with doctors and other HCPs to promote pharmacy services.

Collaborated with District Pharmacy Supervisor in a venture working with third party prescription business resulting to revenue growth from 70% to 90%.

Ensured compliance with federal and state regulations as stipulated by the Texas State Board of Pharmacy.

Reduced wait time on inbound calls to pharmacy from 10 min to average 2 min.

Awarded Manager excellence award every year for implementing superior inventory control standards across six (6) stores in the San Antonio and Houston markets

Acting District Supervisor - temporary replacement for the District Supervisor to cover vacations and assume the role for short periods overseeing 30+ pharmacy departments and their Pharmacy Managers.

Pharmacy Operations

Counselling patients and answering their questions regarding usage of medicine, side effects, interactions, contraindications, patient information privacy, generics, over the counter products and referring to a medical provider as need be

Perform All pharmacist tasks including compounding, drug therapy reviews, verification and medication management

Ensure the pharmacy operates in accordance to regulations, company policies and standards. Responsible for establishing procedures that promote the efficient workflow of the pharmacy and overseeing staff scheduling, assigning roles, coordinating activities and soliciting employee suggestions.

Ensure the use of all elements of Good Faith Dispensing policy in conjunction with state and federal control substance laws

People and Performance Management

Collaborate with Store Managers to define and develop new strategic business opportunities

Maintain current knowledge of information technology associated with pharmacy systems to promote productivity

Perform retail, clinical and wellness services such as immunizations, flu shots, diabetes awareness and other preventative healthcare services

Manage the maintenance, housekeeping and improvement of the pharmacy department to ensure a functioning, presentable and efficient pharmacy

Partner with Store Manager to establish expectations and goals while promoting team work

Manage Pharmacy Staff performance via formal performance reviews. Ensure compliance with employment laws.

Identify, mentor, train and develop high potential team members and proactively manage career progression

Address employee relations concerns and maintain morale and ensuring positive employee-management relationship

Business Performance Management

Responsible for analyzing performance data including pharmacy financial, customer service and inventory. Manage pharmacy asset protection activities and oversee inventory management.

Responsible for pharmacy department planograms and identify innovative alternatives in other parts of the store to increase profits

Merchandising to ensure right product, right price, attractive accessible display, appropriate communication and upselling

Review Key Performance Indicators with Pharmacists, Store Manager and Healthcare Supervisor

Identified pharmacy performance trends and opportunities for improvement

Develop and maintain relationships with local medical community. Reach out to the community to promote the pharmacy through events like brown bag events and health checks

Pharmacist for Walgreens in San Antonio TX 2002-2003

Phone and face to face consultations with patients to educate, advocate and encourage adherence, feedback and conflict resolution.

Reduced wait time from 45min to 15min, answering phone within 3 rings, reduce stock outs to 4% by utilizing alternative distributor chains to ensure product availability within 24 hrs.

Developing, scheduling and training of pharmacy personnel.

Disease State management with emphasis on Diabetes, Hypertension, HIV, Immunization and other high risk preventable conditions.

Inventory control and supply management ensuring adequate stock levels contributing to successful audits.

Involved in Clinical review and data collection certifying accuracy, therapeutic dosage and safety.

Encouraged reporting of prescription incidents, changing punitive perception to prevention and learning moments.

Raised awareness and improved safety systems to track errors and implement changes.

Implemented strategies that allowed members to acquire mandated training in a timely way.

Pharmacist-Based immunization Delivery – use acquired skills to become a primary source for vaccine information and administration

Lead Consultant, J. Kamau and Associates Pharma Consultants 2015 – date

Managing a regulatory team of pharmacists and associates and acting as the operational lead for regulatory activities to ensure regulatory compliance with the national regulator by monitoring legislation, guidelines and the regulatory community.

Acting as a link between global/regional regulatory offices and National Authority and East Africa Community to promote company regulatory strategy for products in the market.

Assisting global and regional regulatory bodies and drafting, updates and submissions of packaging artwork.

Ensuring compliance of all pharmaceutical products in the market and in line with marketing authorization within the region.

Partnering with Principals and local affiliates to define and schedule submissions of new dossiers and variations.

Supervising and coordinating submission of CTD and eCTD dossiers to the East African Community and Kenya Pharmaceutical Regulatory bodies.

Supervising and coordinating submission of listing applications for Herbal Medicines, Food Supplements, Borderline products and Medical Devices to the Pharmacy and Poisons Board in Kenya.

Superintend for various Pharma Companies on an as needed basis and responsible for all regulatory matters pertaining to their products.

Companies served include: Pfizer, Astellas, Amring Pharma, Ricerpharma, Physical Therapy Limited, Spimaco, Tecmed International, Tropikal Brands Afrika, Zengenta, Cavallimed, Orthodynamic, Certeris, Energy Peak Limited, Topline Surgicals Limited and Deccan among others

Group Regulatory Affair Manager Phillips Pharma Group in Kenya 2014-2015.

Supervised and coordinated submission of all the company’s regulatory affairs in Kenya.

Managed a portfolio that included Pharmaceuticals, Medical Devices and Diagnostic Equipment.

Communicated and collaborated with regional offices in Uganda, Tanzania, Sudan, Nigeria, Ghana, Rwanda and their regulatory bodies.

Oversaw quality management systems that were compliant with the Kenyan regulations and internal requirements.

Supervised marketing and distribution in Kenya ensuring regulations were upheld, documentation and compliance was up to date.

Adequately versed in Kenyan Regulatory Affairs Law as regulated by Pharmacy and Poison Board (PPB) under Chapter 224 Laws of Kenya.

Tasked with developing and implementing internal and external SOPs and implementing deviations to enhance the system.

Conferred with the Medical writing team to ensure labelling, promotional and educational material was in accordance to legislation and language used applicable was to the client.

Represented the company at KAPI and served as the chair to the Regulatory sub-committee to address and be the spokesperson for issues affecting importers and Pharmaceutical Companies.

Facilitated safety data exchange in accordance to agreements.

Chief Executive Officer of Wessex Pharmaceuticals Limited, Nairobi Kenya 2012-2014

Wessex Pharmaceuticals Limited is a wholesale business under the Phillips Pharma Group.

Established the operations protocol achieving sales of Kshs 12M monthly.

Recruited and retained staff from 2 to 45 cultivating an enterprising culture that was methodically instilled.

Grew customer base from 0 to over 1500 pharmacies across the Country.

Increased product portfolio from 3 to 7 major suppliers of drugs (diversifying the product basket.)

Implemented innovative business model that allowed payment via MPesa (mobile money) before delivery to small retailers/institutions in the Country.

Conducted CME’s for healthcare professionals on drugs to prevent prevalent conditions that cause child mortality in conjunction with Clinton Health Access Initiative, USAID.

Regulatory Affairs and Distribution Manager Phillips Pharmaceutical Limited, Nairobi Kenya 2011-2012

Registered and acquired license for a company with Pharmacy and Poison Board (PPB.)

Registered pharmaceutical products in Kenya for various multinationals including Novo, Abbott, Merck, Sharpe and Dohme, Johnson and Johnson, Novartis, Takeda and GE with the goal to register products in less than 12 months as stipulated by the PPB.

Liaised with the Pharmacy and Poisons Board Trade Affairs Department to ensure timely compliance and issuance of import permits.

Supervised scientific literature screening for safety reporting to PPB.

Introduced SOPS to address Occupational and Safety to include periodic safety training in compliance with OSHA (that did not exist previously.)

Tasked with Regulatory Affairs, Quality Assurance and Pharmacovigilance documentation and compliance on behalf of the principals represented and the PPB.

Trained staff on drug safety monitoring, documentation, compliance in accordance to the law.

Managed distribution operations, providing customer support, feedback and training.

Also served as Company Pharmacists as well as secretary of the environmental health and safety committee for the Company charged with ensuring health and safety policies and procedures are implemented seamlessly.

Managed 60 warehouse, delivery and support staff

Drafted the first sexual harassment policy for the Company.

Research Assistant to Dr. Lincy Lal Texas Southern University 2002

Thomas Street Health Clinic, Harris County Hospital District Houston TX.

Involved in conducting Cohort Study on Effects of ARV medication adverse reactions and compliance to treatment options.

Responsible for administering questionnaire, reviewing medical charts and tabulating results for statistical analysis.

Involved in patient education, advocacy and encouraging adherence.

Teaching Assistant, Texas Southern University Pharmacy Department Houston TX 2002.

Instructed an average of 90 students enrolled in Pharmacy Practice module at the college of pharmacy

Developed testing materials in the Center facilitating adequate evaluation.

Performed statistical longitudinal analysis on students’ results as part of program evaluation.

Implemented supplementary tutorial program for students requiring one-on-one instruction.

Education.

Post Graduate Certificate in Public Health 2010

University of Texas Health Science Center, Houston TX.

Doctor of Pharmacy 2002

Texas Southern University Houston TX

Professional Memberships

1.Pharmaceutical Society of Kenya (PSK.)

2.Texas Pharmacy Association.

3.National Community Pharmacy Association (NCPA.)

4.Regulatory Affairs Professionals Society

Languages

Bilingual (speech, reading and writing fluency.) English and Swahili.

Awards

1.Inventory Control and Excellency Award Walgreens San Antonio TX(’04, ’05, ’06, ’08, ‘09)

2.Cum Laude Graduate Texas Southern University, Houston TX 2002

3.Dean’s List Texas Southern University, Houston TX 1996-2002.

References:

Mukesh Mehta

073*-******

Phillips Pharma Group

adxzwi@r.postjobfree.com

Julie Mitchell

+210-***-****

Walgreens (USA)

adxzwi@r.postjobfree.com

Daniella Munene

072*-******

CEO- Pharmaceutical Society of Kenya

adxzwi@r.postjobfree.com

More references upon request.



Contact this candidate