Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We are a research-driven biopharmaceutical company. Demonstrated excellent presentation, writing, and project management skills Familiarity with concepts of structured content management preferred Technical expertise in typical office Applications (e.g., Microsoft Office, Adobe Acrobat) and in shared document systems (e.g., Google Docs, SharePoint). Demonstrated participation in medical writing, document, and project teams Ability to prepare, with minimal supervision, a subset of clinical regulatory documents (e.g., CSR, IB, clinical sections of IND/IMPD and CTD) according to company guidelines and international governmental regulations, and to present clinical data objectively in a clear, concise format in keeping with industry guidelines or doctoral-level degree (e.g., PhD, MD, DVM, DO, PharmD) with 3 years of relevant career experience Degree in a life science, preferably related to pharmacy or medicine
Participates in or leads initiatives to improve medical writing processes and standards May participate in orientation and coaching of junior team members or contractor writers Solves problems associated with medical writing scope of work, seeks advice from management and others as needed, and exercises negotiation and communication skills with project team members
Manages medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development, trials, and sections of filings Interprets data and applies knowledge of regulatory/compliance/scientific requirements to document preparation
#Merck medical writer salary registration#
Demonstrates competence in writing, editing, and reviewing clinical study reports, investigator brochures, registration dossier modules, and other clinical regulatory documents per company and other guidelines Represents medical writing in cross-functional teams Applies knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects Is recognized as a scientific contributor and subject matter expert in preparation of selected regulatory clinical documentation We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards. Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products.
The Senior Medical Writer is responsible for development of medical writing deliverables that support the clinical regulatory writing portfolio and works with some guidance and oversight to achieve goals.
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