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Appearances

Past Appearances:

May 7, 2021 - Tim Garver and Nicole Tackmann led a virtual roundtable discussion titled “Medical Writing Planning and Strategies for Marketing Application Submissions” at the

2021 AMWA Carolinas Virtual Spring Conference.


May 10-11, 2021 - Mark Cierpial was part of the faculty for a two-day online seminar titled "US Regulation of Medicines" sponsored by The Organization for Professionals in Regulatory Affairs (TOPRA).

IMPACTConnect

Past Events

IMPACTConnect Games

We had so much fun playing in our first virtual game series that we hosted another in the spring. We got together once a week for 30 minutes on video chat and played Trivia, Would You Rather?, a couple Jackbox Games, and other virtual games.

Ongoing Events

Water Cooler Chats

In an effort to recreate the "chance" encounters we used to have when we were working in person, our CEO, Mark Cierpial, set up 'water cooler chat sessions'. They are 30-minute virtual meetups to catch up, say "hi", and/or get to know each other better. They are a little less spontaneous but no less awesome and will continue for the rest of 2021!

Promotions

Randy Carmichael was promoted in February to Manager, Regulatory Operations! Since joining IMPACT in 2018, Randy has been an invaluable member of the Regulatory Operations team and has contributed to some of our most critical regulatory filings. His attention to detail and commitment to meeting client timelines has set the bar for Regulatory publishing at IMPACT. In Randy's new role as Manager, he will draw from his 30 years of experience to mentor our publishers, as well as manage the day-to-day operations of our publishing group, contributing to our continued success and growth. 

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Stephanie (Steph) Byrd was promoted in April to Senior Clinical Research Scientist. Steph joined IMPACT in April 2020 from a position in scientific writing (with an emphasis on clinical pharmacology), regulatory affairs, and project management at Nuventra, and previously worked in analytical development at Medicago. Steph has impressed internal and external teams with her clean writing, clear and on-point questions, strong communication skills, and thorough approach to any task. She brings her positive attitude and sense of humor to every project. 

New Employees

Edna Hernandez joined the Regulatory Operations group at IMPACT on

March 1. She grew up in New York and moved with her family to North Carolina in 2006. She began working in pharma 28 years ago as an intern and has been on the Regulatory Operations side for 21 years. Outside of work she loves to learn new crafts, read, and attend her children's sporting events.

Michal Nash joined the Regulatory Operations group at IMPACT on March 1. Michal is from Durham, NC. She has been working in the CRO industry since 1990. She's a mom of 3, a grandmother of 1, and loves spending time with family. She also has several rescue dogs and cats. Outside of work she enjoys crafts and gardening.

Aresenia Cuffee joined the Quality Control (QC) team as a QC Specialist on May 24. She comes to IMPACT with 9 years of project management experience in clinical research. She has a master's degree in Clinical Research Administration and is pursuing her PhD in Health Services. Aresenia is originally from Currituck, NC. She has 3 children—2 daughters and 1 son. Outside of work she likes to spend time outdoors gardening, running, and swimming.

Alexis Hoeferlin joined IMPACT as a CRS II on May 24. She has her PhD in Biomedical Sciences and experience in grant proposals and investigator-initiated

early-phase clinical trial protocols. Alexis is originally from Greenville, SC and Charlotte, NC but currently lives in Richmond, VA with her partner Dan and their dog and cats. She enjoys cooking, spending time outdoors, being with family and friends, and listening to live music.

Lauren Sweeney joined IMPACT as a Senior CRS on May 24. She has her PharmD and experience working as a pharmacist and regulatory writer. She is originally from Syracuse, NY and currently lives in Boston, MA with her husband Bobby. Outside of work, Lauren enjoys cooking, traveling, and running. She plans to run the Chicago Marathon this year!

IMPACT on Health

Past Events

Yoga and Meditation

On May 6, a professional yoga and meditation instructor joined IMPACT for a virtual class. The attendees learned about the history of yoga and practiced breathing exercises.

Wine Tasting

On May 20, a sommelier from Raleigh Wine Shop held a virtual wine tasting. The course included samples of three wines and also a lesson on how to distinguish notes and flavors in each wine.

Cooking Lesson

On June 15, IMPACT on Health hosted a virtual cooking class through CozyMeal.com. We had a chef join us live from Florence, Italy for a class where we learned to make Traditional Pasta Carbonara and a chocolate cake!

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Upcoming Events

"Eight Cups a Day" Water Challenge

IMPACT on Health will bring back the 30-day water challenge! Employees will compete to see who most consistently drinks 8 cups of water per day.

Yoga and Meditation

We'll be hosting another instructor-led session later in the summer.

Making an IMPACT

Past Events

Mother's Day Auction

On April 30, 2021 MAI organized a fundraising auction to celebrate Mother's Day. The items up for bid included specialty items from local businesses and items showcasing the various talents of the IMPACT team. A total of $2049 was raised with all proceeds benefiting

The Women's Center

in Raleigh!

March Madness

After a year's hiatus due to the cancellation of the NCAA Men's Basketball Tournament in 2020, the IMPACT March Madness event resumed for 2021. While the Baylor Bears were crowned champions of the tournament itself, MAI was happy to declare three winners of the March Madness event who showed either pure luck or profound basketball knowledge in their bracket picks. The event raised a total of $1210 with the proceeds donated to charities of the winners' choice. The winners chose the following charities:

-Triangle Community Foundation

-Brennan Center for Justice

-The Carter Center

Ongoing Events

Backpack Buddies

Summer is here and it’s time for the annual BackPack Buddies food drive! This event was initiated as part of MAI by Ann Brown back in 2014 and we are striving to keep the streak alive!


Food donations can be dropped off at the IMPACT offices. Monetary donations can be made to the MAI Venmo account.

Want to be part of our events? Email Brandi or Evan to join our mailing list.

Team Feature

The IMPACT Medical Writing Fellowship Program started in May 2018 with a mission to train and develop professionals in the medical/regulatory writing field. Fellows are exposed to a variety of regulatory documents related to the clinical development of investigational and marketed drugs and biologics. The program runs for approximately

9 months of each year and hosts 2 to 4 fellows per class. Accepted fellows receive a competitive salary and our standard benefit package during the fellowship.


IMPACT welcomes 3 new Fellows for the class of 2021. They are Arif Rahman, Hillary Holback, and Paige Dexter. 

Arif Rahman joins IMPACT following a postdoctoral position at the National Institute of Environmental Health Sciences (NIEHS) where he investigated chemical-induced cardiovascular toxicity using microarray gene expression analysis. Arif was also an ORISE Fellow for FDA’s National Center for Toxicological Research and, prior to that, worked as a Product Manager for Incepta Pharmaceuticals in Bangladesh. Arif earned his BS and MS in Pharmacy at the University of Dhaka in Bangladesh before pursuing his PhD in Pharmaceutical Sciences at the University of Tennessee Health Sciences Center in Memphis. Personal interests include reading non-fiction literature (evolutionary biology, astronomy, human history, and human consciousness), balcony gardening, hiking, tennis, and visiting local/national parks.

Hillary Holback comes to IMPACT with experience working for CROs as a Chemistry, Manufacturing, and Controls (CMC) Scientist and Reviewer. As a CMC Scientist, she wrote and reviewed the CMC sections of INDs and NDAs for sponsors to ensure that these regulatory submissions were acceptable for review by the FDA. As a CMC Reviewer, Hillary's work involved reviewing original submissions, as well as crafting language for Information Requests and Complete Response Letters for the FDA in Silver Spring, Maryland. Hillary received her BS in Chemical Engineering from the University of Tennessee, Knoxville and her PhD in Industrial and Physical Pharmacy (Pharmaceutical Sciences) from Purdue University. Hillary enjoys painting, gardening, ballroom dancing, and baking.

Paige Dexter arrives at IMPACT from Research Square Company, where she worked to improve the writing in academic (scientific) manuscripts to a level suitable for peer review. Her editing experience extends back to her graduate student days where she combined her research endeavors with roles such as contract editing with Bioscience Writers and American Journal Experts, and also served as Primary Editor for the Duke Science & Society Science Policy Tracking Website. Paige received her BS in Biology from the University of Alabama and her PhD in Pharmacology from Duke University. Her interests include reading and writing (especially sci-fi stuff) and playing tabletop role-playing games like Dungeons and Dragons with friends. Her favorite sports team is, as you may expect, the Alabama Crimson Tide.

Happy Twelve Year Anniversary to:

Mark (May 1) and Tim (May 1)


Happy Five Year Anniversary to:

Ryan (Mar 1) and Jeff G. (May 15)


Happy One Year Anniversary to:

Jeff T. (Feb 17), Alicia (April 1), Julia (April 6),

Steph (Apr 15), Rory (Apr 16), Jac (May 1),

and Leigh (May 18)

IMPACT on Literacy

Book Club

We will be discussing

"Sapiens: A Brief History of Mankind" by Yuval Harari.

Come Work

With IMPACT

We are looking for a Regulatory Affairs Manager to join our Impact team! Click here to apply.


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IMPACT on Social Media

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