Medical Writer II (Scientific & Medical Services)

Under departmental supervision, the Medical Writer II will research, create, edit, and coordinate the production of clinical documents related to the independent review, including independent review charters, clinical data forms, manual case report forms, applicable reviewer training materials, project deviations, and supplemental imaging reports using all available central content and templates. The Medical Writer II may also develop documents for which no central content is available with appropriate departmental supervision. The Medical Writer II may serve as primary contact with clients and as a mentor or, in exceptional circumstances a line manager, for junior medical writing staff.QualificationsSkills:Excellent 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 team work, and understands the 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 establishes a connection with the client beyond one’s project, to gain repeat business and/or to widen existing scope of services.

Knowledge and Experience:Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, i.e., ICH-GCP.Extensive clinical/scientific writing skills.Scientific background essential; writing experience includes clinical documents.Good 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.If required to perform translation work and quality control of documents written in non-English language, proficiency in relevant language is a prerequisite.

Education:Educated to degree level (biological science, pharmacy or other health-related discipline preferred), nursing or other relevant qualification/experience.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.