Madison Hedrick
- Role
- Senior Medical Writer at Artivion, Inc.
- Location
- Little Rock, AR, US
- LinkedIn followers
- 500 followers
About Madison Hedrick
I am an experienced medical writer and editor with 15 years of experience and a track…
Experience
Senior Medical Writer
Mar 2022 — Present · US
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.
Education
University of Arkansas at Little Rock
Bachelors of Arts
2004 — 2009
University of Arkansas at Little Rock
Master of Arts (M.A.)
2012 — 2014
University of Arkansas at Little Rock
Master of Arts - MA
University of Arkansas at Little Rock
Master of Arts - MA
2011 — 2014
University of Arkansas at Little Rock
Master of Arts - MA
2009
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