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Nancy Gasper Smith, Phd, Rac Email & Phone Number
Senior Vice President, Medical Writing Services
at
Syner-G BioPharma Group
1 work email found
@impactpharma.com
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✓ Verified August 2026
4 data sources
Profile completeness 100%
Current company
Role
Senior Vice President, Medical Writing Services
Location
Durham, North Carolina, United States
Who is Nancy Gasper Smith, Phd, Rac? Overview
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Quick answer
Nancy Gasper Smith, Phd, Rac is listed as Senior Vice President, Medical Writing Services at Syner-G BioPharma Group, based in Durham, North Carolina, United States. AeroLeads shows a work email signal at impactpharma.com and a matched LinkedIn profile for Nancy Gasper Smith, Phd, Rac.
Nancy Gasper Smith, Phd, Rac previously worked as Vice President, Medical Writing Services at Impact Pharmaceutical Services and Principal Consultant, Medical Writing and Submissions Management and Head of Quality Control at Impact Pharmaceutical Services. Nancy Gasper Smith, Phd, Rac holds Phd, Biomedical Technology And Biology from University Of North Carolina At Charlotte.
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Email format at Syner-G BioPharma Group
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*@impactpharma.com
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Profile bio
About Nancy Gasper Smith, Phd, Rac
MEDICAL WRITING AND PROJECT MANAGEMENT EXPERIENCECurrently serves as Project Manager for large regulatory medical writing and consulting projects. Previously served as Project Manager of a multi-year contract for writing and compilation of Clinical Study Reports (CSRs), averaging approximately 20 CSRs per year. Responsibilities include:•Supervising and coordinating the efforts and training of all project team members (up to 12 medical writers and 3 publishers/document specialists)•Resourcing project work •Ensuring compliance with Sponsor policies and procedures•Serving as the primary contact for the Sponsor•Conducting monthly project meetingsREGULATORY/MEDICAL WRITING EXPERIENCE•Regulatory affairs and medical writing activities relating to the clinical development of investigational and marketed drugs and biologics•Regulatory documents include CSRs (Phase I-IV), clinical protocols, annual reports, safety reports, regulatory responses, investigator’s brochures, foreign submission documents, briefing documents, and safety narratives•Strong academic background, with experience in submission and publication of abstracts, manuscripts, poster and oral presentationsPROFESSIONAL HIGHLIGHTS•9 Years Regulatory Experience, including: Medical writing, FDA submissions•7 Years Research Experience, including: Molecular Biology, Virology, Physiology, MicrobiologyEDUCATION, CERTIFICATION, AND LICENSING •Regulatory Affairs Certification (RAC), 2008•PhD, Biomedical Technology and Biology, University of NC at Charlotte, 2006•BS, Biology, University of NC at Charlotte, 2002
Listed skills include Clinical Development, Medical Writing, Cro, Clinical Trials, and 7 others.
Current workplace
Nancy Gasper Smith, Phd, Rac's current company
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11 roles
Nancy Gasper Smith, Phd, Rac work experience
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Senior Vice President, Medical Writing Services
Vice President, Medical Writing Services
Oct 2020 - Jul 2022
Principal Consultant, Medical Writing And Submissions Management And Head Of Quality Control
Oct 2019 - Oct 2020
Consultant, Medical Writing And Submissions Management And Head Of Quality Control
Dec 2017 - Oct 2019
Senior Manager, Medical Writing And Submissions Management
Nov 2015 - Dec 2017
Sr. Clinical Research Scientist
• Provide medical writing services and regulatory affairs consulting to pharmaceutical and biotechnology companies• Author and review clinical/regulatory submission documents (including IND and NDA components, CSRs, Protocols, IBs, FDA Meeting Briefing Documents, etc)• Provide project management services • Mentor Clinical Research Scientists and organize training programs
Apr 2012 - Nov 2015
Clinical Research Scientist
Served as Lead Medical Writer for a variety of projects, including an NDA for an orphan drug product. Responsibilities included: • Author of pivotal Phase 3 CSRs and coordinated the writing, review, and QC of over 100 safety narratives, as well as the compilation of all CSR appendices.• Lead efficacy author, responsible for the ISE and Module 2.7.3 (as well as the efficacy portions of the Advisory Committee briefing document)
Aug 2010 - Apr 2012
Senior Regulatory And Publications Medical Writer
• Dual role of regulatory medical writer and publications writer specializing in the therapeutic area of oncology for a sole Sponsor• Regulatory documents included CSRs, clinical protocols, annual reports, safety reports, regulatory responses, IBs, and foreign submission documents• Publications included Phase 1 and 2 early-phase development manuscripts
Jul 2009 - Jul 2010
Clinical Research Scientist
Sra Global Clinical Development Llc
-Project manager and lead author of 3 Phase II Clinical Study Reports (CSRs) for an antiplatelet agent-Project manager for preparation of FDA Advisory Committee briefing document and presentation-Contributing author of manuscripts and abstracts for a variety of clients for submission to peer reviewed publications and posters for conference presentations-Medical writer within a project team managing the submission of an Investigational New Drug (IND) Application for a neuromuscular blocking agent: Lead author of the General Investigational Plan Contributing author of the Phase I protocol Contributing author of 4 nonclinical study reports-Medical writer within a project team writing clinical sections of an New Drug Application (NDA) for an agent for enhanced magnetic resonance imaging (including abbreviated and synoptic CSRs)-Medical writer writing CSRs (Phase III) and a literature review for an agent in the treatment of neuropathic pain-Medical writer writing a clinical protocol for a chemotherapeutic agent-Medical writer contributing to manuscript and poster preparation for an agent to treat breakthrough cancer pain-Formal regulatory/medical writing training program: an on-the-job training program that included preparation of regulatory documents such as Marketing Applications (NDAs) in traditional and Common Technical Document (CTD) formats, INDs, Annual Reports, Protocols and Protocol Amendments, CSRs, Investigative Brochures.-Advanced training included project management, communicating with regulatory authorities, Chemistry, Manufacturing, and Controls (CMC), and statistics.
Jan 2008 - Jul 2009
Postdoctoral Research Associate
Performed research activities in the area of human immunology/virology at the Duke University Human Vaccine Institute: study of plasma markers of apoptosis during acute HIV-1 infection and development of a human mucosal B cell culture system to asses the ability of memory B cells to respond to recall antigens and other stimuli.Responsible for writing and implementing Assay Plans for human sample allocation and SOPs for instrumentation.Responsible for data collection and manuscript preparation and submission.
Sep 2006 - Jan 2008
2 education records
Nancy Gasper Smith, Phd, Rac education
Phd, Biomedical Technology And Biology
University Of North Carolina At Charlotte
Doctor Of Philosophy (Ph.D.), Biology And Biotechnology
University Of North Carolina At Charlotte
FAQ
Frequently asked questions about Nancy Gasper Smith, Phd, Rac
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What company does Nancy Gasper Smith, Phd, Rac work for?
Nancy Gasper Smith, Phd, Rac works for Syner-G BioPharma Group.
What is Nancy Gasper Smith, Phd, Rac's role at Syner-G BioPharma Group?
Nancy Gasper Smith, Phd, Rac is listed as Senior Vice President, Medical Writing Services at Syner-G BioPharma Group.
What is Nancy Gasper Smith, Phd, Rac's email address?
AeroLeads has found 1 work email signal at @impactpharma.com for Nancy Gasper Smith, Phd, Rac at Syner-G BioPharma Group.
Where is Nancy Gasper Smith, Phd, Rac based?
Nancy Gasper Smith, Phd, Rac is based in Durham, North Carolina, United States while working with Syner-G BioPharma Group.
What companies has Nancy Gasper Smith, Phd, Rac worked for?
Nancy Gasper Smith, Phd, Rac has worked for Syner-G Biopharma Group, Impact Pharmaceutical Services, I3 Statprobe, Sra Global Clinical Development Llc, and Duke University Medical Center.
How can I contact Nancy Gasper Smith, Phd, Rac?
You can use AeroLeads to view verified contact signals for Nancy Gasper Smith, Phd, Rac at Syner-G BioPharma Group, including work email, phone, and LinkedIn data when available.
What schools did Nancy Gasper Smith, Phd, Rac attend?
Nancy Gasper Smith, Phd, Rac holds Phd, Biomedical Technology And Biology from University Of North Carolina At Charlotte.
What skills is Nancy Gasper Smith, Phd, Rac known for?
Nancy Gasper Smith, Phd, Rac is listed with skills including Clinical Development, Medical Writing, Cro, Clinical Trials, Clinical Research, Molecular Biology, Biotechnology, and Cell Culture.
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