Principal Medical Writer

Overview

Assist with the preparation of high-quality medical and scientific writing, from planning and coordination through delivery of final drafts to internal and external clients.

What you'll do

• Assist with researching, writing, and editing routine documents, including clinical study reports and study protocols, and summarize data from clinical studies.
• May assist with more complex clinical, scientific and program-level documents, including IBs, INDs, and MAAs.
• Assist with ensuring compliance with quality processes and requirements for assigned documents.
• May assist in program management activities, including developing timelines, budgets, and forecasts.
• Participate in project launch meetings, review meetings, and project team meetings.

What you'll need

• Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).
• Basic medical writing skills, including grammatical, editorial, and proofreading skills.
• Ability to interpret and present complex data accurately and concisely.
• Effective administrative, organizational and planning skills; attention to detail and quality.
• Ability to work on own initiative and effectively within a team.
• Effective oral and written communication skills.
• Basic knowledge of regulatory documentation and drug development process.
• Good judgment and decision-making.
• Competent computer skills and use of templates; basic knowledge of document management systems and other relevant applications (e.g. Excel, Outlook).

Nice to have

• Experience working in the pharmaceutical/CRO industry.
• Experience in scientific writing.

Details

• Standard schedule Monday to Friday.
• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations, with occasional domestic and international travel.
• Long, varied hours required occasionally.