![]() Proficient in Microsoft Office (Word, Excel, and Power Point) and Smartsheet.Knowledge of cGMP requirements for pharma / biotech industry.Knowledgeable about ICMJE (International Committee of Medical Journal Editors) and GPP3įUNCTIONAL / TECHNICAL KNOWLEDGE & SKILLS:.Proficient in word processing and pertinent software (e.g., Microsoft Office, EndNote).Ability to lead and/or facilitate effective team meetings for deliverables.Ability to apply project management skills to advance numerous projects at a time and to deliver high-quality documents rapidly.Exceptional analytical, communication, organizational, and interpersonal skills.Experience collaborating with clinical investigator authors/collaborators on documents and publication development.Experience working in a matrix team setting.Experience preparing clinical research documents, and manuscripts for publication in peer-reviewed medical journals as well as abstracts and posters or oral presentations for scientific congresses.PhD, MD, or PharmD with at least 3-5 years of clinical documentation and publication development experience for industry in the bio-pharmaceutical sector.Minimum 5+ years of direct scientific writing experience or 3+ years' experience with advanced degree.Advance degree strongly preferred (MS, PhD, MD, PharmD, etc.). Minimum Bachelor's Degree in a scientific field of study.Maybe responsible for training, mentoring or supervising junior staff members.Management of CRO medical writing relationship with regard to all protocol documents, FDA filings, and site communications like memos or addendums.Establish, maintain, and expand business relationships with cross-functional team members collaborating on publication projects to ensure accurate and timely completion/delivery of information based on publication plans.Draft and edit abstracts, posters, and slide decks for presentation at scientific and medical congresses.Ensure quality, alignment with objectives, and timely completion of publications while staying on track with allocated budgets.Drive documentation project timelines and handle multiple projects at a time may support one or more products.Support documents and publication strategies and prioritization of documents and publications. ![]()
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