Senior Medical Writer

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Parexel has an exciting opportunity for a Senior Medical Writer! The Senior Medical Writer will independently research, create, and edit regulatory documents of varied complexity associated with clinical research. Project leadership experience required: primary client contact for medical writing deliverables, collaboration with Parexel or client stakeholders to plan and meet deliverable timelines and expectations in terms of process, content, quality, and team management. Skills Excellent interpersonal, verbal, and written communication skills. Ability to understand all necessary steps in a project, plan ahead, and identify critical paths. Efficiently manages time spent on tasks and proactively identifies deficiency. A flexible attitude with respect to work assignments and new learning; readily adapts to changes. Competent in a matrix environment, values teamwork and understands roles of other project team members. Proven team leadership skills and cross-cultural sensitivity. Exhibits sound judgement by presenting solutions or escalating issues to project teams or departmental management as appropriate. Follows through to ensure problems have been satisfactorily resolved. Strives to understand and satisfy client needs. Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned. Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. Provides departmental expertise and perspectives to promote prospective business opportunities. Provides Parexel colleagues with pertinent information to formalize a sound business strategy. Knowledge and Experience: Extensive clinical/scientific writing skills and demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP. Ability and willingness to work in a fast-paced, rapidly changing environment. Scientific background; 3- 7 years of writing experience includes multiple clinical documents: study reports, study protocols, CTD documents or similar. Advanced MS Office skills (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel). Education: Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.