DFW Ultimate Clinical Research

Introduction: We provide an assortment of services including medical writing and transcription medical or general. We also do academic writing.The Contract Medical Writer authors, edits and provides high-quality clinical documents from planning and coordination through delivery of final drafts for regulatory fulfillment of assigned therapeutic areas and/or products in Clinical Development to US and other global health authorities using appropriate processes, tools and technology. The Contract Medical Writer collaborates on the development of clinical documents in accordance with all applicable regulations to Good Clinical Practice (GCP), applicable regulatory requirements and guidance documents (e.g., 21 CFR Parts 312 and 314, European Medicines Association (EMA) Clinical Trials Directives, International Congress on Harmonisation (ICH) guidelines) company Standard Operating Procedures (SOPs) and internal style guides, as appropriate. Social Media Marketing (SMM) We also provide SMM services. We can get your social media campaign started in no time on several Facebook groups, Twitter, Linked in and Yelp. Requirements I have an advanced degree (MD and a MSC) with a minimum of 10 years of medical writing experience in pharmaceutical, biotechnology, contract research organization or related environment/industry. Special knowledge or skills Demonstrated experience writing, editing, and formatting documents having scientific/medical content and requiring knowledge of Food and Drug Administration (FDA) guidance and EMA/ICH guidelines pertaining to the specific types of documents. Experience in writing clinical protocols and amendments, CSRs, IBs, briefing books, responses to health authorities, and regulatory submission documents. *Demonstrated ability to critically analyze and to clearly, accurately, and concisely prepare all clinical regulatory documentation, including major submission and/or complex documents in English. Excellent verbal and written communication skills. Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members. Analytical thinker with excellent problem solving skills and the ability to adapt to changing priorities and deadlines. Ability to prioritize and multi-task What makes our service great is we provide services to clients on a case-by-case basis that allows us to provide high-quality service. Our main goal at the end is customer satisfaction. We will work with our customers until they are satisfied.