At Parexel you'll team up with some of the best minds in the industry to get new treatments to the patients who need them most. Parexelis one of the largest providers of medical writing services worldwide and has managed thousands of writing projects in more than 29 countries in North and South America, Europe, Asia, and Africa. As a result of continued customer satisfaction, the Team is growing. We are currently looking for: Home Based Clinical Regulatory Medical Writers in the US and Canada (Full Time & Temporary Roles Available) As aParexel Senior Medical Writer, you will be exposed to different project teams,therapies and devices, aswell as a diverseportfolio of clients. The ability to understand our clients' needs and achieve quality results is critical for us to continue to be one of the best clinical research organizations (CROs) in the world. To accomplish this, we believe that you must have the abilityto work independently as well as collaboratively every day. As a Senior Medical Writer with Parexel you will research, create, and edit all documents associated with clinical research. Responsibilities include: lead author and primary client contact for medical writing projects, working with other Parexel departments and clients to set and meet internal/external deliverable timelines, project leadership, and training and support of junior medical writing staff. Our writers are an integral part of clinical teams that support our clients worldwide and they assist those teams in writing and coordinating successful documentation across a wide range of therapeutic areas. You will: Use your clinical knowledge to write and edit clinical study documents Use your project management skills to lead teams to quality and timely deliverables Partner with sponsors as their primary client contact for medical writing projects Mentor and train junior medical writing staff Skills: Excellent interpersonal, verbal, and written communication skills. Consistently produces documents of high quality. The ability to stay focused under tight timelines. Attention to detail and proactivity. Understands all necessary steps in a project, plan ahead, and identify critical paths. A flexible attitude with respect to work assignments and new learning; readily adapts to changes. Efficiently manages time spent on tasks and proactively identifies deficiency. Manages multiple and varied tasks with enthusiasm and prioritizes workload with attention to detail, e.g., organizational skills. Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity. Negotiates on behalf of medical writing to ensure resources, timelines and expectations are aligned. Understands and satisfies client needs. Gains trust and establishes a connection with the client beyond one's project. Knowledge and Experience: Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP. Accountable to provide document-specific advice to clients. Scientific background essential. Extensive clinical/scientific writing experience is required and consists of multiple clinical documents: study reports, study protocols, CTD documents and/or similar. Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge and ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel). Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation. Education: Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.
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