The professional has over 10 years of experience as a clinical researcher and medical writer specializing in managing multidisciplinary teams and regulatory submissions. They have experience in clinical workflows including assays, treatments, and data analysis. The professional has held several leadership roles in healthcare and life sciences companies focused on clinical research, telehealth, biomedical informatics, and network security.

1. PROFESSIONAL SUMMARY
Tenured clinical researcher and medical writer specializing in managing multidisciplinary teams to design,
prepare, and implement clinical plans, strategies, protocols, analysis plans, study reports, and publications.
Regulatory/Writing Experience: Specialization in site monitoring responsibilities including pre-study, initiation of
sites, monitoring and final close-out. Manage regulatory submissions and collect data for agency submissions
from CRO’s, including: ICH, 21 CFR 820, 21 CFR 801, GCP, NDA, IND, MAA, CTA, MOH and country/site IRB/IEC
approvals/notifications. Senior-level technical writing with proficiency in CRF and statistical analysis plans,
written to client SOP and templates. Knowledge of clinical and regulatory documents and publication practices
including ICMJE and CONSORT. Write global value dossiers (GVDs), US formulary dossiers (Academy of Managed
Care Pharmacy Format), and Health Technology Assessment (HTA) submissions. Develop manuscript submissions
to peer-reviewed journals, as well as the creation of abstracts for scientific conferences.
Practice in Clinical Workflows: Markers, assay development, compound treatments, western
blotting, MSD/ELISA, BCA assay, FACS, PMBC isolation, multicolor flow cytometry, data analysis. Conduct assay
development and validation experiments using various immunoassays. Purchase biological products including
Reagents and Instruments in the areas of Cell and Molecular Biology. Maintain electronic lab notebooks and
collate results into organized reports or presentations. Reconcile IP at study level in collaboration with vendors
and CRO. Manage TMF set-up, ongoing quality review, and final reconciliation.
PROFESSIONAL EXPERIENCE
Associate Medical Officer, THE NATIONAL ALLIANCE OF RESEARCH ASSOCIATE PROGRAMS March 2012-
Present
Responsible for operating standardized scientific procedures and techniques in a regulated environment for
research applications in molecular diagnostics; contribute to the planning, design, execution and interpretation
of clinical PCR assay optimization experiments; make detailed observations, records data, as well as assess the
processes and results for reliability, efficacy, and compliance. Primary role is to monitor multi-center clinical
studies, ensure the studies are conducted in compliance with current applicable federal, state, local and
corporate and IRB regulations and procedures including Good Clinical Practices (GCP) and International
Conference on Harmonization (ICH). Manage and write nationwide clinical study sites to ensure subject safety
and compliance with the study protocol, timeline, budget and regulatory parameters. Oversee assay
development, optimization, and execution. Initiation of selected clinical study sites by overseeing training
related to the protocol and management of the study. Verify data entered on the CRFs is consistent with clinical
documents. Ensure compliance with appropriate regulatory (FDA, HBP, HIPAA, QSR, Title 21 CFR etc.) and
internal SOP guidelines.
Vice President, MEDWEB May 2008-March 2013
Managed all sales activities for a 24-year old Global SaaS-based medical technology firm offering telehealth in a
wide array of ologies. Offerings included integrated medical imaging, management and network security
systems, and innovative healthcare technologies providing agility and improvements in clinical workflow, access
and quality of care. Focused on network security and workflows in mHealth and Telemedicine software and
medical devices, as well as EHR, PACS and RIS.

2. Directed all alliance sales activities of innovative enterprise-class data center offering cloud and managed
services via Infrastructure as a Service (IAAS). Focused on Bioinformatics as a Service, a SAAS-model workbench
supporting a growing library of bioinformatics research tools including BLAST, Galaxy and RNA-Seq.
Offering entailed a virtualization environment consisting of high availability applications and data libraries widely
used in EMR/EHR workflow protocols and genomics sequencing. The applications outsourcing (AO) model was
disruptive in the Biotech and Life Sciences industries and increasingly necessary due to stringent needs in
network security and regulatory compliance. This innovative on-demand offering enabled scientists to perform
compute and storage intensive genomics sequencing research in a secure, highly scalable online environment.
Vice President Partner Development, INTEGRALIS March 2003-May 2008
Directed the Alliance sales of managed security services, professional services, security software and CPE delivery
to 68 vendors and 16 resale partners/distributors across the globe. Larger global partners included telecoms,
energy consortiums and network security solutions for global enterprise partners, VAR's and OEM's.
Managed large global sales team in this capacity, inclusive of Directors, Channel Managers, Inside Sales teams
and Marketing and PR groups. Liaised closely with operational teams, and assisted in the development of new
software applications and ad-hoc hardware appliances. Consistently exceeded revenue goals by 30-40%
throughout tenure, and created and nurtured global partner relationships that have become intrinsic to the
foundation of the Company and account for 40% of overall domestic revenue.
Vice President Carrier Sales Americas Region, CABLE & WIRELESS April 1997-March 2003
Managed nationwide Alliance arbitrage program. Established, conveyed and managed Carrier sales forecasts for
global sales teams both direct and via channel. Directed strategic planning of the migration from voice to IP
services, including short and long-term blueprints for market share and revenue growth. Managed re-
architecture of nationwide performance management process. Led organizational and team building initiatives
that reduced carrier turnover to a single-digit percentage. Increased market share by 30% in the carrier space by
leveraging switched resale, hosting and wireless technologies. Led national teams in launch of new IP services,
including sales planning, channel mix, pricing, promotion, and customer experience definition.
EDUCATION
JOHNS HOPKINS UNIVERSITY Post Master’s Certificate in Biomedical Enterprise, Expected 2018
UNIVERSITY OF MASSACHUSETTS-AMHERST Masters of Business Administration: Operations and Information
Management, 2010
NEW YORK UNIVERSITY Masters of Science: Biomedical Information, 2006