Cheryl McCoy
Head Regulatory Medical Writing, Cross-therapy Areas and Medical Affairs @Johnson & Johnson Innovative Medicine
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WORK HISTORY
Head Regulatory Medical Writing, Cross-therapy Areas and Medical Affairs @Johnson & Johnson Innovative Medicine
EDUCATION
Fisk University
Bachelor of Science - BS, Chemistry
Wayne State University
PhD, Biochemistry
SKILLS
ABOUT CHERYL MCCOY
Visionary Leader with a mentoring/coaching leadership style and expertise in change management.Leadership Positions:VP and Global Head Medical Writing Oncology and member of Oncology Development Operations Leadership teamSenior Director, Medical Writing (MW) and Medical Communications and member of Medical Affairs Leadership Team Director and Head of medical writingGlobal Head & Director for US and UK MW groups Member of Clinical Operations Leadership Team Member of Clinical Development Leadership Team Member of Global Medical Affairs Core Leadership Team Organizational & Managerial Skills: Facilitating the preparation, review, & editing of documents for global regulatory submissions to ensure consistency with regulatory strategy & key scientific & product messagesCollaborating with internal and external stakeholders responsible for regulatory submissions & advising on content to ensure harmonization of contributions from various authors as well as with regulatory guidelinesPlanning, coordinating and producing MW activities for clinical & regulatory documents to agreed timelines & within agreed budgets for the entire portfolio of programsMedical Writing Skills:Creator of \'FAMOUS\' principles for Medical Writing and Communications Point of contact for Eisai MW to provide input into ICH E3 updateExtensive experience in writing, editing and reviewing regulatory documents, publications, & other scientific/medical literature; Expertise in documentum/edms; developing templates and SOPs for regulatory/clinical documentsExcellent understanding of US and international regulatory and ICH guidelinesCommunication Skills: Working & collaborating with matrix teams in a global (US, EU, Japanese) cross functional team environmentEstablishing partnerships and managing relationships with external vendors and suppliersWorking closely with key scientific opinion leaders, scientific investigators, and field-based medical science liaisons to drive strategy and content of clinical publications and presentations; using this content to shape and develop compelling stories around products and brands.Therapeutic Areas: Oncology, renal, immunology, neurology, cardiovascular & vaccines
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