Medical Writer

Overview

Provide high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients.

What you'll do

• Serve as primary author who writes and provides input on routine documents such as clinical study reports and study protocols, and summarizes data from clinical studies.
• May assist with more complex clinical, scientific and program level documents, including IBs, INDs, and MAAs.
• Ensure compliance with quality processes and requirements for assigned documents. May assist in determining best practices, methods and techniques for achieving optimal results.
• May assist in program management activities, including developing timelines, budgets, and forecasts for assigned deliverables.
• Represent the department at 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 2+ years).
• Solid 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.
• Good knowledge of regulatory documentation and drug development process.
• Great judgment and decision-making skills.
• Good computer skills and skilled with client templates; good 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

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