Ram Balani

* ****** *****, *******, ** ***** Email: ac9h88@r.postjobfree.com

Mobile Number: 201-***-****

Experiences/Skillsets: IT-Pharmaceutical-Healthcare (medical/clinical research) Ideal positions: Project Manager, Data Analyst, Technical Writer, IT/Life Science Consulting

CEO/Business Development - FDASmart Inc. www.fdasmart.com

December 2007- January 2019

(** Retired FDASmart start-up business founded January 2007 on February 2019; seeking independent contractor or good-fit full-time employment work-leveraging diverse, seasoned IT & regulatory experiences with pharmaceutical or healthcare (life sciences) industry for clients **)

●Founded own start-up consulting company, conducting new business development and leading projects offering pharmaceutical consulting services to East (India/China) West (US/Europe) business development to include US FDA regulatory consulting services, new market development, outsourced software development, etc.

●Consulting services offered included:

-Assisting foreign companies with US FDA regulatory compliance, early stage 510K planning.

-Assisted US /Western companies with establishing new market development in Asia (India /China) through self-hosted webinar/conference offering, blog, etc. http://fdasmart.com/Webinars-and-Conferences-US-India-Life-Sciences.html

-Established a successful China-India marketing campaign for conference show attendance by Indian pharmaceutical supply chain manufacturers & distributors. www.fdasmart.com/fdasmart/apichina

-Remote CRA training over Skype by former US FDA associate/subject matter expert to Indian CRA training institute.

-Accomplished speaker at global pharmaceutical/biotech conferences and trade shows on various topics including US FDA cGMP in Emerging Regions (India-China) at leading pharmaceutical events such as Cphi (Germany)

-Contributor to various print media and online publications including ChemOnline,

Teknoscienze.

-Consulting assignment for global search for China API plant manufacturer possible acquisition.

-Sold free-roaming, remote, virtual wearable wireless Internet enabled camera with real-time video/audio technology to Bristol Myers (Syracuse, New York) and Pfizer Quality System-Peapack, NJ. (SmartInspect) to assist with overseas cGMP manufacturing quality systems and inspections.

Founder/Business Development - Innovative Information Systems, Inc. June 1991- December 2007

Various Assignments:

●Contractor/Vendor to Pfizer Central Research, Groton-CT – June 1992-1995

-Entrepreneurial contract awarded and funded by Pfizer Central Research - $ 250K USD for establish remote (Mumbai, India) outsourced clinical data management group; created and managed evergreen group presence in India liaising with Pfizer Mumbai-India and Pfizer Groton-CT Clinical Research IT group. Staff for Pfizer start-up group in India grew to 15 contractors.

●Maintained satellite office in New London, CT to develop other clients including third party outsourced IT professional with Lotus Notes/Domino Administration, Norwalk Hospital web based Electronic Medical Record (Lotus Notes/Domino).

●Start-up (internally funded) software development – Venue Maitre’D – start-up created to build and host location based portal at trade shows, malls, cruises leveraging the nascent wifi proliferation (802.11) at busy public/private places (e.g. Jacob Javits Center-NYC, South Street Seaport Mall-NYC, NASA Museum (Huntsville, Alabama) etc. and handheld wireless devices including Microsoft Pocket PC, Palm Pilot, Laptops. Failed to scale business development due to lack of sufficient broadband cellphone (2G) wireless connectivity and absent advance smartphone features.

Independent Consultant/Software Development at Various Locations:

●Consultant at Allendale Insurance Company-Johnston, Rhode Island (DEC All-in-One Development)

●Consultant for Chicago Mercantile Exchange (CME) (Fortran/with DEC RdB Relational database)

●Consultant for Anheuser Busch, St. Louis-MO (2 months, Digital Equipment Corporation (DEC) Vax Rally software development LIMS (Laboratory Information and Management System, Process Engineering Group)

Employee Position(s) - Full Time Employment-Various Locations: May 1980 - May 1991

●Capgemini Sogetti (St. Louis, Missouri) IT Consulting – Full Time Employee

Various projects in St. Louis-Missouri including Monsanto Chemical Company (Lotus Notes macro development) and Southwestern Bell-Fortran Programming

●MRT (Mississippi River Transmission Corporation, St. Louis-Missouri) –Full Time Employee

Software development with IBM System 38 /RPG on natural gas remote pipeline SCADA system. (Supervisory Control and Data Acquisition)

●Mallinkcrodt Pharmaceutical Company (Research & Development, St. Louis-Missouri) – Full Time Employee

IT Desktop Support including LIMS (Laboratory Information Management Systems) replacement project management with pharmaceutical R&D staff and LIMS vendor including systems specification, evaluation, acquisition, installation and database and network administration support.

Washington University School of Medicine, St. Louis-Missouri – Full Time Employee 1976- May 1980

●Clinical Research Laboratory Full time Employment – Jerry Lewis Neuromuscular Research Center

Performed clinical laboratory assays including Elisa immunoassay. Worked with various chemical test and assays to measure muscular dystrophy biomarkers including Creatine, Creatinine, Triglycerides, etc using fluorimetry, spectrophotometry chemical instrumentations & techniques.

Education:

●Masters in Business Administration (M.B.A.) – Majored in Operations Research/Statics (Part-time -night school)

St. Louis University, St. Louis-Missouri

September 1975- July 1980

●Bachelor of Arts (B.A.) – Majored in Biology/Chemistry

St. Louis University, St. Louis-Missouri

June 1972- June 1975

Other Educational Achievements/Endeavors:

●June 2016

Big Data Introduction – Certificate – Coursera Online Academy, UCSD – University of California, San Diego Big Data Specialization

February 2019-April 2019 & Ongoing:

●Self Training-Self-Study - Currently doing self-study/tutorials on installed Microsoft Database technologies and associated SQL database utilities.

Current-MS-SQL Server, with SSMS (SQL Server Management Studio) and T-SQL; MS Powershell; Microsoft SSAS & SSRS & SSIS next; SAS/CDISC-SAS University Edition

●Miscellaneous:

-Well versed with US FDA pharmaceutical regulatory compliance including GCP, GLP, GMP, QMS, ICH Q10 etc. and US FDA ANDA, NDA and medical devices guidance.

-Familiar with Medical Device Reports (MDR), Post market Surveillance concepts including US FDA MAUDE database (Manufacturer and User Facility Device Experiences), 21 CFR Part 11, 21 CFR 803 adverse reporting (Form 3500), Pre-market Medical Device Approval (PMA)- 510K submissions.

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