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Madison Hedrick
Madison Hedrick Senior Medical Writer at Artivion, Inc.

Madison Hedrick stands out as a premier medical writer and editor, boasting a robust professional journey of 15 years that distinguishes them in the biotechnology research industry. With over 5,300 LinkedIn connections, Madison demonstrates a formidable network within the sector, a testament to their extensive involvement and credibility. Specializing in crafting precise and impactful medical documents, Madison has successfully written or substantially edited over 150 grant proposals, culminating in over $200 million in funding from distinguished bodies such as NIH and various foundations.

At the heart of Madison's expertise is their proficiency in regulatory writing. This includes producing Clinical Evaluation Reports (CERs), Clinical Study Evaluations (CSEs), Investigator Brochures (IBs), alongside comprehensive clinical and post-market documentation. Their methodical approach to conducting systematic reviews, meta-analyses, and meticulous adherence to update and create regulatory reports – particularly for medical devices in alignment with MEDDEV 2.7/1 and EU MDR requirements – is unmatched. A researcher at the core, Madison capably identifies biases, assesses research gaps, and evaluates data soundness to deliver work that consistently meets the highest standards of scrutiny and regulatory compliance. Their ability to execute both primary and secondary research, following PRISMA, CONSORT, and STROBE guidelines, further underlines their methodical and analytical prowess.

Currently thriving as a Senior Medical Writer at Artivion, Inc., Madison ensures product compliance with US and International regulations, supports clinical regulatory submissions, and collaborates seamlessly across various company departments. Their previous leadership roles include serving as CEO of US Medical Research Services, LLC, and holding influential positions at top-tier medical device firms like Smith+Nephew and DePuy Synthes. Notably, Madison's contribution to the field extends beyond their corporate achievements; they are active in the American Medical Writers Association, where they have taken leadership roles at the chapter level and are slated to serve on the 2024 Communicative Committee. Madison's scholastic foundation, including a Master of Arts from the University of Arkansas at Little Rock, complements their professional endeavors, underpinning their formidable capacity in technical writing and content development.

More about this expert

Full name
Madison Hedrick
Location
Little Rock, Arkansas, United States
Title
Senior Medical Writer
Company
Artivion, Inc.
Industry
Biotechnology Research
LinkedIn Connections
5337
Summary
I am an experienced medical writer and editor with 15 years of experience and a track record of high-level achievements and providing excellent services for my employersI try to set the bar high and always remain ethically sound and fundamentally up-to-date on all aspects of medical writing and research. Grant writing experience includes writing or substantively editing over 150 proposals with a current total of over $200 million in funding for NIH, foundation, and other grant mechanisms. Regulatory writing experience includes writing and revising CERs, CSEs, IBs, as well as clinical and post-market documentation--I create systematic reviews of the literature, including meta-analysis, is a valuable when updating or creating regulatory reports--especially CERs for medical devices in accordance with MEDDEV 2.7/1 and transitioning EU device CERs from MDD to MDR requirements. I have research experience and can look for bias in literature, gaps in research, soundness of methodologies, and validity and significance of data and reported statistics. I am able to carry out both primary and secondary research (and reporting it in compliance with PRISMA, CONSORT, and STROBE guidelines). My years of experience working with observational and experimental studies (currently I have an 85% success rate for publication) is proven in my authorship and acknowledgment in 50+ journals (co-authoring a manuscript in Clinical Pediatrics, another in Pediatric Emergency Care, a recent case study in Hand Surgery and Rehabilitation, and presentations, reviews of workshop outlines, and creating content for conferences). I serve on the 2024 Communicative Committee of the American Medical Writers Association and volunteered for six years at the University of Arkansas at Little Rock Alumni Board of Directors.
Skills
Contract Research Organization (CRO) Content Development

Education

University of Arkansas at Little Rock
Master of Arts (M.A.)
Attended in 2012 - 2014
Field of study: Professional
University of Arkansas at Little Rock
Bachelors of Arts
Attended in 2004 - 2009
Field of study: Technical Writing

Positions

Artivion, Inc.
United States
Senior Medical Writer
Mar 2022 - Present

Ensure product line compliance with US and International regulations and standards as applicable to clinical regulatory requirements including document preparation and submissions
Writing clinical regulatory documents supporting clinical deliverables for product lines.
Support regulatory submissions for clinical requirements for product line.
Coordinating deliverables for the CER, PMCF and SSCP process for product lines
Collaborate with Clinical, R&D, Quality, Regulatory, Risk Management, and Field Assurance, and Marketing Effectively communicate timelines and hold team members accountable to agreed upon timelines required for project dates.
Conduct literature reviews and write research summaries related to product line.
Prepare Instructions for Use and assist with labeling and labeling changes.
Collect, query, analyze, distribute and present clinical data.
Develop and maintain any applicable clinical research databases as necessary.
Conduct basic statistical analyses for technical support of product line.
Interface with technical reps, regional mgrs, and research teams for technical training and addressing customer questions/concerns.
Communicate with customers/field staff ab planning (clinical trials, complaints, problems, and general correspondence).
Evaluate and report on adverse events, complaints, and failures associated with the product.
Coordinate the execution of peer-reviewed publications, posters, abstracts; marketing literature.
qOversee timelines, budgets, budget change forms, accruals, and monthly reports.
Develop clinical protocols and/or investigational plans, informed consent forms, case report forms, handouts, SOPs, analyses, etc.
Prepare status reports.
Liaison between Artivion, investigational sites, and CROs (as applicable) to coordinate and document clinical research studies.
Respond to written/phone inquires from investigational sites.
Knowledge of regulatory requirements for Clinical Evaluation Reports and Post Market Requirements.
US Medical Research Services, LLC
Little Rock, Arkansas Area
Chief Executive Officer
Jul 2019 - Jun 2022

www.usmedresearch.com
Smith+Nephew
Evidence Evaluation Specialist (CER)
Nov 2021 - Jan 2022

Generate Clinical Evaluation Reports (CERs) for class I-III devices that comply with MEEDEV 2.7.1 Rev 4 and EU 2017/745 (MDR). Responsible for performing systematic literature reviews and managing evidence databases.
DePuy Synthes
Senior Medical Writer
Oct 2021 - Dec 2021

Specializing in Orthopedic Class 2 and 3 medical devices, I worked as a member of medical operations to create regulatory documents for compliance with EU-MDR, FDA, and other standards and guidance. Work included updating existing CERs from MEDDEV 2.7.1 Rev 4 to EU MDR standards, working on a large EU MDR project. The project required evaluations to obtain CE certifications and updates of both existing CERs and novel products for product lines in the orthopedics division. SSCPs, CEPs, CERs, and multitude of other documentation are part of the workload.  
American Medical Writers Association (AMWA)
Southeast
Immediate Past-President, President, President-Elect Southeast Chapter
Jul 2017 - Oct 2021

The Southeast Chapter of the American Medical Writers Association (AMWA) serves the states of Alabama, Georgia, Mississippi, and Tennessee. The Chapter’s objectives are to raise the standards of practice and achievement in medical communication by:

Bringing together those persons within the area of the Chapter who are involved in the communication of medical information so that they may share views, experiences, and goals. Such persons include writers, editors, illustrators, publishers, and those active in research, documentation, audiovisual techniques, public relations, and advertising related to the subject of medicine and the life sciences.
Furthering the professional development of Chapter members through educational programs and certification.

Promoting high levels of communication by making the Chapter’s educational programs available to all AMWA members and nonmembers.

Encouraging nonmembers to become members of AMWA and to participate in Chapter activities.