Medical Writer II

Under departmental supervision, the Medical Writer II will research, create, edit, and coordinate the production of clinical documents associated with submissions to regulatory authorities, including but not limited to: study protocols, model informed consents, interim and final clinical study reports, and safety update reports. The Medical Writer II will also be responsible for the production of clinical study documentation associated with clinical trials that may not be included in a regulatory submission. The Medical Writer II may serve as the primary client contact.QualificationsSkillsExcellent interpersonal, verbal, and written communication skills.Ability to consistently produce documents of high quality.Demonstrates attention to details and proactivity.Ability to understand 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.Ability to efficiently manage time spent on tasks and proactively identify deficiency. Manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills.Willingness to work in a matrix environment, values the importance of teamwork, and understands roles of other project team members. Possesses team leadership skills and cross-cultural sensitivity.Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned.Strives to understand and satisfy client needs.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.

Knowledge and Experience:Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP.Extensive clinical/scientific writing skills.Scientific background essential; writing experience includes multiple clinical study reports.Advanced word processing skills, including MS Office (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).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.EEO DisclaimerParexel 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.