RENGITH MATHEW, MD/MBA

* ******* *****

Randolph, NJ 07869

adqw6q@r.postjobfree.com

832-***-****

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

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