Lead Editor for a blockbuster oncology drug with 40 US indications that generated 25 billion dollars in sales in 2023Over 20 years of experience in the Pharmaceutical, Biotech, and Life Sciences fields editing, copywriting, and proofreading various types of communications, including brand labeling and review for all components of a brand family, scientific slides, technical reports, scientific manuscripts, proposals, meeting materials, online and interactive media, and clinical study reports for the pharmaceutical industry. Extremely well versed in the AMA (11th Edition) writing, editing, and proofreading style. Demonstrated ability to analyze and interpret scientific data, scientific protocols, and investigator brochures. Extensive experience in FDA, DDMAC, PRC, Medical, Legal, and Regulatory (MLR) review processes and have attended many Regulatory Review meetings on behalf of clients. Wide range of experience in numerous therapeutic areas and specialties including the ever-changing arenas of Managed Care and Continuing Medical Education (CME). Experience with editing and reviewing scientific manuscripts for submission in numerous styles including AMA, Chicago Manual of Style, house style, and any Client Style Guides, in a professional and accurate manner, especially under pressure to meet tight submission deadlines.In serving the pharmaceutical/biotech industry, a high sense of urgency and focus on cost containment are essential.Ensuring projects are prepared appropriately for clients’ MLR review needs, overseeing the accuracy and messaging of projects through all stages of content development, providing strategic oversight and assurance for the editorial quality of projects, developing and cultivating relationships with thought leaders, interfacing with clients, account services, art, and meetings departments regarding material content and design, and, managing and coordinating both internal and external freelance proofreaders, writers, and editors.

Support the promotion review process to ensure that materials and programs made available to customers reflect Organon’s high standards.Provide leadership for Editors supporting promotion review.Provide strategic direction and ensure alignment with business priorities.Ensure team understanding and compliance with defined standards of review through training and documentation.

Medical editing, copy editing, proofreading, fact checking, and annotatingVeeva submissions for clientsDeveloping and maintaining departmental, functional area, and product style guidelines (style sheets)Quality Control Reviews of all regulatory documents, including investigator brochures (new/annual updates), Clinical Trial protocols and amendments, clinical study reports, patient narratives, investigational new drug and new drug application submissions, and other documentsPromotional education materials for physicians and other healthcare providers (eg, slide decks) sales consultants and sales training and medical science liaisons (pre-launch and new indication launch learning systems, annotated reprints/package inserts, reference compendiums, objection handling materials, white papers, and e-learning sales training programs)Providing editorial expertise for numerous New Product Launches and updates to client documents

Edited and proofread pharmaceutical and medical promotional materials including electronic media, presentations, brochures, package inserts, instructions for use booklets, packaging, etc.Responsibilities included comparing documents to source materials to ensure consistency and accuracy; identifying mistakes and/or inconsistencies in spelling, grammar, punctuation, content, layout, and compliance using standard editorial and proofreader’s marks; becoming familiar with client brands,