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Medical Writing, Slides, & Regulatory Documents

Regulatory, Publications, Medical Education & Meetings

Science Author, Inc. provides expert medical writing, research, slide deck preparation and regulatory writing in a broad spectrum of therapeutic areas, including oncology, neurology, immunology, respiratory and ophthalmology and more. The scope of our medical writing services includes regulatory documents, clinical journal publications, medical education, and meeting presentations, coverage and synopsis. If you need assistance in any of these or related areas, contact us for a free consultation and proposal for your project.

Clinical trial documentation (Phase 1-4) Protocols, consent forms, clinical study reports, investigator brochures, other Drug submissions IND, EOP2 meeting package, NDA, CTD/eCTD, Briefing documents	Periodicals Primary manuscripts, review articles, journal supplements, and “letters to the editor” Event documentation Abstracts, posters, slide decks Other Newsletters, product monographs, book chapters

Provider education tools & patient education resources Pharma sales rep training materials CME slide decks & programs, CME test or discussion questions	Medical Meeting on-site coverage Advisory boards, national & satellite symposia, KOL meetings Meeting reports, meeting news updates & executive summaries

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“The quality of Marithea’s work has been consistently high, and her delivery of documents is always on time, many times earlier than her deadline.  Despite the fact that most of our communication is carried out via email and brief teleconferences, she always comprehends what is needed…  asking insightful questions that show she has full understanding of the process and exemplary attention to detail.  When I have a difficult assignment that needs to be completed within a tight timeframe, she is one of the first persons I consider.”
Lisa B., Vice President, Regulatory Operations
Sirion Therapeutics, Inc.

Dr. Goberville’s work is of the highest quality. We have engaged her for various types of projects including onsite conference coverage and manuscript development. She has a great deal of experience and is very clinically knowledgeable.  There has never been an occasion where we were disappointed with her work.  Simply put – “she gets it”.
Nathan K., Senior Director of Global Clinical Operations
PRIME Oncology, Inc.

“Thank you so very much for all of the work you have done on this project. You have been a rock throughout this process and a complete pleasure to work with. I heard nothing but positive feedback from the team whenever you were involved. This is can be a tough group, but they all very much appreciated everything you did. I’ve said it a hundred times, but, one hundred times more, thank you.”
Angela C., Senior Medical Writer
MedImmune, Inc.

“Thea is a take-charge person who is able to present various documents to clients as well as have direct conversations with faculty on data, etc.  She is an asset to our writing team and perfectionist in all of her work. In addition to writing skills, she is very professional on site at meetings and all interactions with clients and faculty.  When working with Thea I have a level of confidence knowing I have one of the best medical writers on my projects.”
Angela F., Account Manager
R&R Healthcare Communications

“It was a tremendous benefit to have your expertise on our team.  Your previous experience in clinical trial documentation development greatly expedited the development process and helped us to meet our commitments to the Principal Investigators.  Moreover, the fact that we received 100% approval on the documentation from our Regulatory Affairs department can be directly attributed to your extensive knowledge of the regulations and standards governing an international, multi-center trial.”
Paulena M., Technical Document Specialist
Digene, Inc.

“Thanks to Marithea for achieving the goal of a final draft CSR for our global phase 2 study ahead of that initially planned.   We appreciate your timeliness and attention to quality and detail you provided.”
Joseph P., Senior Vice President of Product Development
Cerimon, Inc.

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Request Information or Proposal

We welcome the opportunity for a free, no-obligation discussion of your project. All of our work is customized to meet the client’s exact specifications. For more information about our medical writing services, or to discuss the specific needs of your project(s), please complete this short form below. Please include the following information in your description:

• Service requested (e.g., writing, slides, backgroun research, referencing, editing, other)
• Therapeutic area(s) covered (e.g., oncology, neurology, immunology, etc.)
• Audience (Physician, Clinician, FDA, Pharma Sales)
• Document type (e.g., conference abstract, journal article, slide set, poster, etc.)
• Deadline

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Marithea Goberville, Ph.D.

President & Principal Medical Writer

Marithea is an accomplished and highly qualified medical, regulatory and scientific writer. With dozens of commercial biotech research products, scores of published and internal written works, and thousands of meeting hours and slides (advisory board, FDA review, trade and CME conferences) to her credit, she brings experience at every level of science, from laboratory research and product development to large-scale medical communication projects and clinical trials.  Marithea draws upon her superior research skills, analytical ability and medical writing expertise to assist clients with medical,  regulatory or scientific communication projects in the U.S. and abroad. Marithea’s education and experience best position her for projects addressing physician, scientist and clinical audiences in the topics of oncology, neuroscience, ophthalmology, respiratory, virology and other therapeutic areas. She thrives on the challenges of  developing clear and concise regulatory writing and slide presentations as well as all forms of journal publications and clinical trial documentation.

Through her company, Science Author, Inc., she provides fast, scientifically accurate and high-quality consulting and project deliverables, including regulatory filings, slide decks, manuscripts, abstracts, product monographs, posters, advisory board presentations, executive summaries, clinical study reports, study protocols, investigator’s brochures and other clinical documents.

Contact us for a free consultation.

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