Medical Writer II

3 days ago

Apply Now

Receive Emails with Similar Jobs

Parexel

WebsiteLinkedInAll Job Openings

Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+

💰 Venture Round on 1990-01

Description

• As a Parexel Medical Writer II you will be exposed to different project teams, therapies and devices, as well as a diverse portfolio of clients. • 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. • 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. • 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.

Requirements

• 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 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. • Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP. • Extensive clinical/scientific writing skills, specifically study protocols, model informed consents, interim and final clinical study reports, and safety update reports. • 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.