regulatory writerClinical Grant and Regulatory Writer Dr. Mary

Dr. Mary has 14 years of experience as a consultant and medical writer. She holds an MD and an MS in biostatistics. Her experience includes 6 years as a successful freelance medical writer, during which she has concentrated on regulatory writing, technology assessments for health insurers, and continuing education materials for physicians. Her previous employment in the pharmaceutical industry includes 2 years as associate director of medical writing for Cell Therapeutics, a pharmaceutical company focused on oncology, and 8 years as a project director, biostatistician, and medical writer for Axio Research, a contract research organization devoted to data management, biostatistics, and support of independent data monitoring committees. Before transitioning to the pharmaceutical industry and medical writing, she spent 9 years as a practicing obstetrician, during which she owned her own practice and jointly supervised 23 employees.

Dr. Mary has written numerous protocols and clinical study reports for early and late phase studies. She is familiar with all clinical documents, including annual reports, briefing documents, investigator brochures, regulatory submissions, and drug applications. She has written materials in many therapeutic areas including cardiology, oncology, ophthalmology, psychiatry, hematology, emergency medicine, neurology, vascular devices, gastroenterology, pulmonology, urology, trauma, gynecology, addiction medicine, rheumatology, immunology, nephrology, critical care, obstetrics, neurosurgery, anesthesiology, geriatrics, tropical diseases, and infectious diseases.

Dr. Mary holds an MS in biostatistics and can describe inferential study results. As a biostatistician, she prepared over 100 reports for data monitoring committees and clinical studies.

In addition to regulatory writing, she has collaborated on manuscripts, posters, and abstracts, and assisted many academic investigators with writing applications for publicly funded grants.

She has also written white papers, monographs, test questions, learning objectives, needs assessments, and point-of-care materials for the academic, healthcare, continuing education, and health insurance markets.

Dr. Mary is able to proactively guide the development of a document, anticipate obstacles, and develop solutions. She places high priorities on providing excellent personal service, meeting deadlines, continually expanding her general medical knowledge, and adhering to the highest standards of scientific honesty.


To work with clinical grant and regulatory writer Dr. Mary, please visit our quote page and request her in the description area.


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