RENGITH MATHEW, MD/MBA
Randolph, NJ 07869
*********@*****.***
Medical Affairs professional with demonstrated experience in regulatory, protocol / study design, medical standard operating procedures (SOPs) and medical information. Demonstrated ability to interact with healthcare professionals, to make decisions with limited information as well as working effectively as part of cross-functional team.
ACADEMIC BACKGROUND
Advanced Post Graduate Diploma in Pharmaceutical Medicine-
James Lind University 2017 - 2019
Doctor of Medicine (M.D) - Avalon of School of Medicine 2012 - 2015
MBA/MHA - Davenport University 2013 - 2020
Bachelor’s in medical science - University of Sint Eustatius School of Medicine 2010 - 2012
Bachelor’s in biology/Minor in Chemistry -Texas Southern University 2001 - 2007
PROFESSIONAL EXPERIENCE
Novartis Pharmaceuticals
April 2020 - Present
Associate Director Medical Information
Rare Disease, Malignant Hematology & Solid Tumor
Create and deliver timely responses to unsolicited medical information inquiries/requests from HCPs in a multi-media environment and record information according to Novartis and regulatory guidelines
Reviews and Approves Medical Response Documents (MRDs) for product portfolio, as needed
Conduct medical review of promotional materials during Oncology Marketing PRT (oMAP) meetings
Collaborate with cross-functional teams to identify strategies and execute tactics to support Novartis Oncology products (e.g., medical product teams [MPT], launch management teams [LMT], Global Oncology Scientific Affairs)
Develop comprehensive compendia strategies for product by interfacing with key internal stakeholders and lead submission process
Develop and provide therapeutic and product training to multiple internal customers (e.g., sales force, customer interaction center (CIC), MSLs, clinical)
Create and update clinical section of AMCP dossier and ensure timely delivery to HCPs upon solicited requests
Perform literature review for product NDA annual submission in a timely fashion
Staff medical information booths for annual meetings in oncology, hematology, and rare diseases
Assist Med Info Directors/Executive Director in maintaining constant interactions with Global Oncology, US Clinical Development and Medical Affairs (US CDMA), Marketing / Sales functions, in order to ensure alignment of US Oncology MI strategy with business needs
Support Med Info Directors/Executive Director in developing and implementing operational processes for internal department as it relates to daily MI activities
Participate in multiple projects to ensure medical information capabilities are utilized, both cross-functionally and internally
Monitor, collect, and analyze metrics for MI activities and report on a regular basis
Assist Med Info Directors/Executive Director in conducting audits on MI activities to ensure compliance with all legal, regulatory, and Novartis guidelines
Be a resource and provide appropriate coaching and mentoring to MI colleagues (e.g., SRD creation, oMAP interaction, IMDT and LMT contributions, compendia strategy)
Strong knowledge of Oncology drugs and disease state information
Developed Medical Information Document showing the day-to-day function of system management
Provided interactive platform demonstrations and training to medical information colleagues as well as to sales force and customer interactive center (CIC) teams across product.
Process NDA annual submissions on time.
Check the medical accuracy and assist with regulatory department in development/periodic update of product prescribing information/ package inserts
Provide oversight for Prescribing Information overview at sales training; ensure product training/updates to medical information colleagues on the front-line.
Alignment and development of product medical information plans during launches with cross-functional departments.
Develop, update, and submit compendia listing within defined timelines, e-dossier and ensure dossiers are provided on time to HCPs upon unsolicited requests+
Develop Style guide for medical response document
Develop medical information guidance document to address medical inquiries
Provide scientific support at medical congresses
Support Marketing/Sales team by providing scientific expertise point of view.
Collaborate with Medical team in creation and assistance of MOD/MOA videos for pipeline compounds
Assist Med Info team with creation of patient friendly MOA Brochure for pipeline compounds
Novartis Pharmaceuticals
Senior Manager Medical Information
Benign Hematology
July 2019 – April 2020
Author of Standard Response Documents (SRDs)
Reviewer and Approver SRDs for Oncology product portfolio
Utilize customer service skills to meet or exceed customer expectations
Accountable to provide accurate and balanced medical / scientific answers to unsolicited HCP inquiries
One-to-one interaction with HCPs
Unsolicited HCP medical inquiry fulfillment via:
oCongress booth staffing at Oncology, Hematology and Rare Disease medical meetings (e.g., AACR, ASCO, ASH, SABCS, SCDAA, ENDO)
oTelephone, video on-demand, click to chat, email, Opt-in service
oStaffed medical information booths for annual meetings in oncology, hematology, and rare diseases
oMedical reviewer of promotional materials for Oncology Marketing promotional review teams
Global Oncology Scientific Affairs
Accountable for development and execution of compendia strategies
Accountable for development and providing therapeutic and product training to multiple internal customers
Medical Science Liaison and Internal Medical
Accountable for creation and updates to clinical section of AMCP dossier
Manage Oncology Scientific Writing offshore team that develops legacy product SRDs
Accountable for comprehensive literature review for product NDA annual submission
PRA Intl. (Contractor – Novartis Pharmaceuticals)
January 2017 – July 2019
East Hanover, NJ
Medical Information Manager
Author of Standard Response Documents (SRDs)
Reviewer and Approver SRDs for Oncology product portfolio
Utilize customer service skills to meet or exceed customer expectations
Accountable to provide accurate and balanced medical / scientific answers to unsolicited HCP inquiries
One-to-one interaction with HCPs
Unsolicited HCP medical inquiry fulfillment via:
oCongress booth staffing at Oncology, Hematology and Rare Disease medical meetings (e.g., AACR, ASCO, ASH, SABCS, SCDAA)
oTelephone, Video on-demand, click to chat, Email, Opt-in service
oStaffed medical information booths for annual meetings in oncology, hematology, and rare diseases
oMedical reviewer of promotional materials for Oncology Marketing promotional review teams
Global Oncology Scientific Affairs
Accountable for development and execution of compendia strategies
Accountable for development and providing therapeutic and product training to multiple internal customers
Medical Science Liaison and Internal Medical
Accountable for creation and updates to clinical section of AMCP dossier
Manage Oncology Scientific Writing offshore team that develops legacy product SRDs
Accountable for comprehensive literature review for product NDA annual submission
Medical Office Manager
Centra Clinic, Houston, TX
2008 – 2010
Hiring, Training Staffs, Scheduling employees, address staff issues and conducts regular performance reviews.
Tracked equipment and devices, manage inventory, ordering of supplies, liaise with vendors regarding equipment and supplies
Prepared payroll, designing filing systems, reviewing and approving supply requisitions.
Provided instructions by defining procedures for retention, protection, retrieval, transfer, and disposal of records.
Planned and Implemented office systems, layouts, and equipment procurement.
Ensured that staff uses the correct coding when designating the diagnosis or results of procedures used.
Achieved financial objectives by preparing an annual budget and oversee the financial aspects of the business, such as billing, banking, and accounting.
Implementation of Health Insurance policies, Benefit programs, Key Performance Indicator and Electronic Medical Records
Senior Pharmacy Technician
Walgreens Pharmacy
2001 - 2008
Accurately preparing prescription orders, verifying prescription information and dosage
Entering patient information into pharmacy system, processing and submitting insurance claims
Provided Quality Customer Service to patients and other healthcare providers
Oversee the work of and instruct pharmacy technicians to work on all customary dispensary and stock control
Supported pharmacy managers in training new pharmacy personnel with all procedures
Organized purchase and record activities to maintain pharmacy, oversee stocks on hand and refund overstocks
Connected with vendors, establish orders for conventional and specialized items and discover specialized items needed
Clinical Fellowship Experience
Neurology and Oncology Clerkship
oCNS Nevada, Las Vegas
oJan 2015 – Mar 2015
Dermatology Clerkship
oInpatient clinic, Las Vegas
oDec 2014 – Jan 2015
Cardiology Clerkship
oSummerlin Hospital/North Vista Hospital/Valley Hospital, Las Vegas
oOct 2014 - Nov 2014
Emergency Medicine Clerkship
oNorth Vista Hospital, Las Vegas
oAug 2014 – Sept 2014
General Surgery/Neurosurgery Clerkship
oValley Hospital/ UMC Hospital, Las Vegas
oMay 2014 – July 2014
OB/GYN Clerkship
oValley Hospital/St Rose Hospital, Las Vegas
oJan 2014 – April 2014
Pediatrics Clerkship
oSunrise Hospital, Las Vegas
oOct 2013 – Dec 2013
Psychiatry Clerkship
oSt Rose Hospital, Las Vegas
oJune 2013 - October 2013
Internal Medicine/Family Medicine
oJackson Park Hospital, St Rose Hospital
oChicago, Las Vegas
oNov 2012 - May 2013
HONORARY RECOGINITION
Honors in Core Clerkships: Internal Medicine, Family Practice, Surgery, OB/GYN, Pediatrics, Psychiatry
Honors in Elective Clerkship: Emergency Medicine, Cardiology, Ophthalmology, Dermatology, Neurology
Recognition at St Rose Hospital administration in Las Vegas for Patient Care and Satisfaction.
TEACHING EXPERIENCE
USMLE Step 1, 2 and 3 tutors for medical students.
Assign work hours for all Medical Education employees
Conduct required training for all Medical Educators
Recruit and hire potential tutors
Assist in developing appropriate study strategies
CERTIFICATIONS
Board Certified Medical Affairs Specialist (In Progress)
Advanced Post Graduate Diploma in Pharmaceutical medicine
Clinical Research Associate (CRA)/ Clinical Research Coordinator (CRC) Certification
Advanced Cardiac Life Support (ACLS)
Basic Life Support (BLS)
Advanced Hyperbaric Chamber Technician
TECHINCAL SKILLS
Windows, Word, Excel, PowerPoint, Publisher, MedDRA, GeoDart, Aprimo, FUSE, MiDOCS, Sales Force.com, Midus