Experience. Integrity. IMPACT.
Experience. Integrity. IMPACT.

What We Do

IMPACT’s Leadership Team

markMark Cierpial, PhD, RAC
Chief Executive Officer & Acting Vice President, Regulatory Services

Mark Cierpial, PhD, RAC is the Chief Executive Officer & Acting Vice President, Regulatory Services at IMPACT.  In addition to running the day-to-day business operations of the company, Mark consults with clients on strategic regulatory issues facing their drug and biologic development programs, and interacts with the FDA on their behalf on a regular basis.  Mark has worked in the pharmaceutical industry for over 20 years, starting his career as a Clinical Research Scientist at Burroughs-Wellcome Co. (now GlaxoSmithKline) in 1992.  During his career, Mark has worked in big pharma, small pharma, and CRO settings.  His positions have included Chief Operating Officer at Lineberry Research Associates, where he oversaw all aspects of clinical, regulatory, biometrics, and quality assurance operations; Vice President of Regulatory Affairs and Strategic Drug Development Services at SRA International (formerly Constella Group), where he was responsible for the provision of global regulatory affairs, medical writing, and drug development services; and Vice President of Regulatory Affairs at Inspire Pharmaceuticals.Mark received his PhD in Psychology from the University of Virginia and was a postdoctoral fellow then Research Assistant Professor in the Department of Psychiatry at the Duke University Medical Center.

In his free time, Mark enjoys all kinds of boating on the lakes and rivers of North Carolina and Virginia.  He’s somewhat of a political junkie, even though it frustrates him to no-end.  As a transplanted yankee from Massachusetts, he supports the professional sports teams from Boston, also frustrating at times.

nancyNancy Gasper-Smith, PhD, RAC
Vice President, Medical Writing Services

Nancy Gasper-Smith, PhD, RAC is Vice President of Medical Writing Services at IMPACT.  Nancy’s primary responsibilities include managing and authoring regulatory medical writing projects, mentoring Clinical Research Scientists, and overseeing Quality Control within IMPACT.Nancy has over 9 years of regulatory medical writing experience. Prior to joining IMPACT, she was a Senior Medical Writer and Scientific Communications Specialist with i3 Statprobe and a Clinical Research Scientist at SRA International and its legacy company (Constella Group).  During her career, Nancy has authored over 40 CSRs and has experience authoring many types of regulatory documents, including clinical sections of marketing applications, protocols, IBs, IND applications, and regulatory agency briefing documents. Nancy has served as the Project Manager for a Strategic Partnership involving writing and compilation of 25 to 30 CSRs yearly (see case study).  Nancy has also operated as the Project Manager for large regulatory medical writing and consulting projects.

Nancy’s background includes a BS in biology and a PhD in biomedical science and biotechnology from the University of North Carolina at Charlotte.  Her graduate work in immunology continued with a year of postdoctoral work at Duke University’s Human Vaccine Institute.  After transitioning into clinical research, Nancy obtained her Regulatory Affairs Certification (RAC) in 2008.

Outside of work, Nancy enjoys spending time with her husband and young daughter.  When she’s not working on her backyard koi pond or a home improvement project, she’s splitting her vacation time between the Delaware shore and the Adirondack Mountains of upstate New York.

ChristinaChristina Williams, PhD, RAC
Senior Director, Medical Writing Services

Christina (Chrissy) Williams, PhD, RAC is a Senior Director, Medical Writing Services at IMPACT.  Chrissy’s primary responsibilities include managing a group of IMPACT’s Clinical Research Scientists, authoring regulatory medical writing projects, and leading the submission development initiative.Chrissy has over 15 years of experience in regulatory affairs and medical writing. Prior to joining IMPACT, she was an Associate Director of Clinical Submissions Writing at UCB Biosciences, Inc. and a Senior Regulatory Scientist at CATO Research.  During her career, Chrissy has authored clinical sections of US and EU marketing applications as well as labeling updates, protocols, CSRs, IBs, US and EU regulatory agency briefing documents, and responses to US, EU, and rest of world regulatory agency questions. Chrissy also has experience in marketing application submission planning and management, line management, recruiting, and proposal development.

Chrissy’s background includes a MA in Biological Psychology from St. Mary’s College of Maryland and a PhD in Biological Psychology from the University of North Carolina at Chapel Hill.  She completed her postdoctoral work in the Department of Pharmacology and Cancer Biology at Duke University Medical Center. Chrissy obtained her US Regulatory Affairs Certification (RAC) in 2003.

Outside of work, Chrissy can be found reading, traveling, cheering on her children at various events, and supporting the UNC Tarheels!

JenniferJennifer Garver, RAC
Director, Medical Writing Services

Jennifer (Jenny) Garver, RAC is a Director, Medical Writing Services at IMPACT.  Jenny’s primary responsibilities include managing a team of IMPACT’s Clinical Research Scientists, managing and authoring regulatory medical writing projects and submission documents, collaborating on NDA submission teams, and training IMPACT’s new hires on writing clinical study reports (CSRs).Jenny has over 7 years of regulatory medical writing experience, during which time she has authored over 30 CSRs in addition to the clinical sections of marketing applications, IND and NDA annual reports, protocols, IBs, orphan drug applications, pediatric study plans, and regulatory meeting briefing books.  Jenny received her BS in biology and chemistry from Frostburg State University as well as her North Carolina science teaching certification.  Jenny then subsequently worked for the North Carolina Public School System, during which time she taught middle school science and served in other capacities at the elementary school level.  Following her time working for the North Carolina Public School System, Jenny transitioned to the world of regulatory medical writing in 2010. In 2016, Jenny earned her US Regulatory Affairs Certification.

Outside of work, Jenny enjoys spending time with her husband and three children and vacationing on Bald Head Island.

markJeff Golden
Senior Director, Regulatory Services

Jeff Golden is the Senior Director, Regulatory Services at IMPACT.  Jeff’s primary responsibilities include overseeing the Regulatory Operations function at IMPACT as well as day-to-day project work for IMPACT’s clients.Jeff has 15 years of experience in the pharmaceutical industry with 12 in Regulatory Operations.  His career began at Fujisawa (later Astellas Pharma US) where he worked in the central document room preparing documents for electronic submission and archive. His career in Regulatory Operations began when he joined TAP Pharmaceuticals (joint venture of Abbott Laboratories and Takeda Pharmaceuticals; later Takeda Pharmaceuticals) where he served as a publisher on the company’s first NDA in eCTD format for Uloric®.  During his years of service at Takeda Jeff successfully managed the publishing and submission management activities to approval for some of the company’s priority programs, including Uloric®, KAPIDEX™ and the Alogliptin family of products.  Following his years at Takeda, Jeff joined the Regulatory Operations group at Chimerix, Inc. where he served as the head of Regulatory Operations managing the day-to-day submissions and project planning activities for their upcoming marketing application.

In addition to Jeff’s extensive experience working on US applications, he has published numerous applications for the rest of the world. During his tenure at Takeda, Jeff published new drug applications in the Americas, Europe, Asia and Africa.  In addition to his experience with major applications, Jeff has experience with preparing and publishing clinical study reports, briefing packages, and advisory meeting packages.

Jeff is recognized in the eCTD publishing community and is a member of the local Electronic Concepts Technical Discussion (ECTD) Group and IRISS Global Submission Group.  Jeff has a BS in Business Management from Elmhurst College, Elmhurst, IL.

When he’s not at work, Jeff enjoys spending time in his woodshop, exploring all the great parks and greenways with his wife and two young sons, and cheering for his Chicago teams, especially the Cubs.

Amanda DerrAmanda Derr, CPA, CGMA
Senior Vice President, Business Operations & CFO

Amanda Derr, CPA, CGMA is the Senior Vice President (SVP) of Business Operations & CFO at IMPACT. As SVP, Business Operations & CFO, Amanda is charged with maintaining and developing the infrastructure necessary to support IMPACT as it continues to grow and flourish.  She is also responsible for building and maintaining effective working relationships throughout IMPACT and for mentoring leaders across the company.Amanda is an accomplished leader in the contract research industry, with more than 20 years of experience across a variety of functions, including finance and accounting, HR, quality assurance, legal, technology, and proposals & contracts.  Prior to her transition into the industry, Amanda worked as a public accountant for Deloitte.  During her career, Amanda has worked, primarily, for privately-held contract research organizations, including Rho, Inc. and Lineberry Research Associates.  These positions in private and rapidly growing companies have allowed Amanda to be involved in a wide array of leadership roles, with responsibility for setting business strategy, providing broad oversight of business operations, and leading a number of client facing functions, such as quality assurance and proposals & contracts.

Amanda received her BS in Accounting from Guilford College, with minors in French and Mathematics. In addition, Amanda is licensed in the State of North Carolina as a Certified Public Accountant and holds the credential of Chartered Global Management Accountant.

Outside of work, Amanda can be found on the sidelines at her daughter’s field hockey games, enjoying a high school (soon to be college!) musical theatre performance, or quietly reading southern fiction.

JacJac Camp
Director, Information Technology

Jac Camp is the Director, Information Technology (IT) at Impact. As such, Jac is responsible for Impact’s IT strategic plan and user experience in areas of business technology, data security, cloud resources, telecom, and networking.Prior to joining Impact, Jac spent much of his 22-year career as a technology leader spanning various industries – from Marketing/Sales, Financial, Healthcare, to, most recently, Pharma. Continuously building on past experiences, Jac focuses a passion for technology into an adaptive technical program that has benefited each company he’s served. Jac’s leadership experience in such diverse industries, along with his hands-on approach, make him a unique resource with invaluable insights into Impact’s current and future technology needs.

Away from work, Jac is an avid motorcycle rider. Additionally, he loves traveling with his wife and children, often spending time away from the busy world and enjoying time exploring the Great Smoky Mountains, with the occasional detour to The Outer Banks. At home, you’ll often find him in his garage turning wrenches on cars, motorcycles, or whatever else might be broken or in need of some “tweaking.” Jac’s signature hands-on approach is apparent in all aspects of his life, from his hobbies to his career.