SUMMARY:

• A Global Medical Affairs professional with over ten years of experience supporting Clinical Research (Phase I - IV) within various therapeutic areas such as Oncology, Hematology, Cardiovascular, and Infectious and Pulmonary/Respiratory/Immune Diseases, Endocrinology and Medical Devices.
• Provide strategic planning and implementation of Global Clinical Development Programs(GCDP).
• Experience in academic and business publishing: support the development of Publications and communications to ensure accuracy and timely presentation of scientific data
• Extensive experience reviewing and interpreting product data from phase I-IV clinical trials, clinical development and statistics to ensure appropriate and scientific accuracy of Publications
• Execute all Good Publication Practice (GPP) guidelines by AMA, ACGME, AOA and communications agencies to ensure all Publications follow the Global Publications Clearance (GPC).
• Experience in working with Promotional Review Committee ( PRC) Team for 10 years.
• Write, edit, and submit Abstracts for poster and oral presentations and Manuscripts/Publications working with investigators, internal stakeholders and medical communications vendors

TECHNICAL SKILLS:

SKILLS: Computer skills: MS words/power point/excel Negotiating skills Inter - personal skills Communication skills Management skills Leadership skills

PROFESSIONAL EXPERIENCE:

Health Care Consultant

Confidential, New York, NY

Responsibilities:

• Provide medical and scientific expertise in all aspects of clinical trials (phase 1-4) including design, protocol development, execution, analysis, Confidential t safety, quality of medical data, statistical analysis.
• Provide strategic planning for implementation of Clinical Research Development Program.
• Provide selection of CRO's and criteria and of all CRA staff as well as Team building strategy.
• Prepare and help implement clinical trials budget and grant applications
• Provide scientific and medical expertise for Compliance and in support of Business Development Activities such as Promotional, Marketing strategy, Sales, Advertising and Publications.
• Review CSR ( Clinical Study Reports ) and summary of clinical data safety to be submitted to IRB and FDA.
• Review US product complaints reports including AE, SAE and Pharmacovigilance international
• Review scientific and medical reports for Compliance with Local/State/Federal regulations.
• Provide expertise on HEOR, HOVA and complex medico-legal issues as requested by clients
• Provide scientific communication direction & strategy and of scientific communication personnel.

Confidential, New York, NY

Director of Clinical Research

Responsibilities:

• Implement and develop all CME and non-CME al activities for resident physicians, students and faculty.
• Evaluate al curriculum and performance of resident physicians, students and faculty
• Support the GME Director on publication and communications to ensure accuracy and timely presentation of scientific data at Professional meeting and Peer reviewed Journal Publications.
• Educate and execute all the Good Publication Practice guidelines by AMA, ACGME, AOA and clients communications agencies to ensure that all publications follow the Client Global Publications Clearance.
• Review and interpret product data from phase 1-4 clinical trials, clinical development and statistics to ensure appropriate and scientific accurate publications.
• 10 years experience as an Editor in Medical with experience working with Medical Faculty assisting in research and Content Development for preparation of Manuscripts, slides and online programs in multiple disease states. Manage DATAVISION database to ensure compliance of all entries with assigned publications.
• Write, edit and submit abstracts for poster and oral presentation an manuscripts developed by investigators and medical communications vendors.
• Represent the Publication and Communication and Promotional department on Global Medical Team meetings

Confidential, Newark, NJ

Director of Clinical Research/ Vice-Chair

Responsibilities:

• Supervised 20 clinical trials (phase 1-4) studying the efficacy and safety of medical devices and pharmacological agents for FDA approval process for Clients and Investigator Initiated Studies ( ITT ).
• Interact with Safety Review Team ( SRT ), Data Monitoring Committees ( DMCs) and Clinical Trials Heads.
• Write/Review Clinical Efficacy & Safety Review Plan ( SRP) of Regulatory dossiers
• Collaborate with Clinical Development Organizations to ensure Compliance of documents submitted (study design, protocol, etc.) are accurate and of high quality and Compliant with Legal, Regulatory Rules.
• Serve as the clinical and scientific expert for FDA clinical trials within the product team.
• Mentor and teach study coordinators, CRA, medical residents in the clinical research conduct, FDA/State regulations and protocol compliance for various research projects.
• Assess clinical research activities, recommend improvements in research curriculum consistent with institution's protocol guidelines
• Responsible for submission of IRB applications of all research protocols and their amendments.
• Experience in Medical Practices, Regulations and Guidelines published by OIG, PhRMA and FDA.
• Working knowledge of Central Coding using MedDRA and WHODD terminology
• Monitor/Report of Safety Data including adverse events (AE) and serious adverse events (SAE) and Pharmacovigilance to IRB and Client sponsors in Compliance with Good Clinical Practice (GCP).
• Prepare and execute research budgets to conduct clinical trials within the hospital.
• Select clinical research staff ( Principal Investigators, sub-principal investigators, research coordinators)
• Create and implement Confidential t recruitment and retention strategies.

Confidential,Middletown, NJ

Medical & Scientific Compliance Manager/Project Manager

Responsibilities:

• Assume the overall responsibility of medical and scientific aspects of all phases of clinical trials (protocol development and management, Confidential t safety, quality of medical data, statistical data analysis).
• Provide strategic planning and implementation of Clinical Product Development Program.
• Participate in selecting//monitoring of all CRA staff and CRO
• Prepare and execute all the clinical trials budgets with the CEO
• Provide Scientific and Medical Compliance expertise as medical representative of Promotional Review Committee (PRC) in support of business development activities (advertising, promotional al activities, marketing, sales strategies).
• Edit/monitor clinical reports for Compliance with State/Federal FDA Regulatory submission and updates.
• Review product complaints, medical device reporting criteria and AE.
• Provide appropriate medical monitoring to ensure Confidential t safety, adequate reporting and coding of AE and SAE in clinical trials.
• Review summary of clinical safety data in preparation for submission to FDA.
• Participate in Process Improvement and Risk Management
• Experience in Global Quality Assurance and Compliance ( QA & QC ).