Stephen M. Parker

Background

About Stephen M. Parker

Senior medical editor/quality control reviewer with 12 years’ experience in the medical affairs and regulatory departments of pharmaceutical companies (20 years’ total experience as an editor)• Reviewed/edited a wide range of materials, including clinical study reports and protocols, investigator’s brochures, clinical manuscripts for publication, poster and slide presentations, CTD modules, PopPK reports, and medical info letters• Involved in the launch of several major products and expanded indications in a variety of therapeutic areasKEY ACCOMPLISHMENTS:• Helped prepare for the launch of several major products of three pharmaceutical companies (Gilead Sciences, Vertex Pharmaceuticals, and Cephalon) as an employee in their medical communications and regulatory departments– Worked to ensure that the regulatory documents and journal publications of data from the pivotal and extension trials were accurate, error-free, clearly written, and conformed to style guides and templates• Created the in-house style/quality control guides for the medical communications departments at Vertex and Cephalon; also helped to shape the departments’ publications SOPsSKILLS AND ATTRIBUTES:• Extraordinary attention to detail, accuracy, consistency, and precision of language; intimate knowledge of grammar, idiom, and medical terminology, and of the AMA’s Manual of Style• Knowledge of regulatory document management systems, publication management software (DataVision/PleaseReview), citation software (EndNote), MS Office suite, SharePoint, Adobe Acrobat DC Pro, Documentum, PubMed archive, MS Teams, OneNote, KaiNexus, and PerfectIt• Understanding of International Council for Harmonisation (ICH) guidelines for clinical study reports, trial protocols, and Common Technical Document modules, and guidelines for publication of clinical trial data in medical journals (e.g, CONSORT, ICMJE, Good Publication Practice)• Adept in working with regulatory documents (e.g, clinical trial protocols, CSRs, Integrated Summaries, Investigators’ Brochures) and in communicating with biostatisticians• Ability to manage multiple projects, maintain timely and thorough communication with co-workers, garner consensus among key players, and meet deadlinesSpecialties: • Medical writing• Medical editing• Proofreading