Medical Writer II (US)

Worldwide Clinical Trials•Durham, NC

12d•$66,500 - $131,500

About The Position

The Late Phase Medical Writer II is responsible for carrying out medical writing activities on Phase I-IV studies, including USA, Europe and Rest of World (ROW), in accordance with Sponsor specifications in a timely, accurate, and efficient manner, within budget and to the written, scientific, and ethical standards in accordance with regulatory requirements and Worldwide quality management documents (QMDs).

Requirements

Excellent written and spoken English.
Ability to accurately interpret data and express findings in a clear and concise written manner.
Excellent project/time management and organizational skills, as well as the ability to work independently.
Flexibility in meeting challenging deadlines and changing requirements while working on multiple projects.
Comprehensive Microsoft Office skills, especially Word, but also PowerPoint, Excel, and Outlook.
Ability to communicate with professionals from a variety of backgrounds.
University/college degree (life science or related allied health profession) or equivalent combination of education and experience that provides the individual with the required knowledge, skills, and abilities to perform the above responsibilities.
Minimum of 3 years of Medical Writing experience or equivalent role as determined by management to have sufficient skills and knowledge.
Available for domestic and international travel, including overnight stays (valid passport).

Responsibilities

Prepare and lead the medical writing team on Phase I-IV study documents such as protocols and protocol amendments, informed consent documents and assents, clinical trial reports (CTRs) including efficacy sections, CTR narratives, Investigator Brochures, and other study documents in accordance with regulatory requirements (USA, Europe and/or ROW) and QMDs.
Prepare and lead the medical writing team on Phase I-IV study documents that are applicable in regions outside of the USA, including but not limited to IMPDs, Protocol Lay Summaries, CTR Lay Summaries, Assents etc.
Proactively contribute creative ideas, concepts or suggestions to provide added value to projects.
Work both independently with minimal supervision and as part of a team.
Coordinate internal and Sponsor document review cycles.
Review and perform MW QC review of documents, as needed.