Principal Medical Writer

This is a fully remote position, open to applicants in India.

📋 Description

• Conduct research, compose, and refine routine documentation, including clinical study reports and study protocols.

• Summarize findings from clinical research.

• Provide assistance with intricate clinical, scientific, and program-level documents, such as IBs, INDs, and MAAs.

• Ensure adherence to quality processes and standards for assigned documentation.

• Support program management tasks, which include creating timelines, budgets, and forecasts.

• Engage in project launch meetings, review sessions, and project team discussions.

• Collaborate with both internal and external clients to foster effective and efficient communication.

• Produce high-quality medical and scientific writing, overseeing the process from planning and coordination to final drafts.

⛳️ Requirements

• A Bachelor's degree in a scientific field or an equivalent and relevant formal academic/vocational qualification.

• Prior experience that provides the knowledge, skills, and abilities required for the role (typically 0 to 2 years).

• Experience in the pharmaceutical/CRO industry is preferred.

• Familiarity with scientific writing is advantageous.

• Fundamental medical writing skills, including grammar, editing, and proofreading abilities.

• Capability to interpret and present complex data in an accurate and succinct manner.

• Strong administrative, organizational, and planning abilities; meticulous attention to detail and quality.

• Capacity to work independently and effectively as part of a team.

• Proficient oral and written communication skills.

• Basic understanding of regulatory documentation and the drug development process.

• Sound judgment and decision-making capabilities.

• Competent computer skills, including the use of templates; basic knowledge of document management systems and relevant applications such as Excel and Outlook.

• Willingness and ability to occasionally travel to site locations both domestically and internationally.

• Availability to work occasional long and varied hours.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday to Friday work schedule.

• Opportunities for collaboration and professional development.

• Global team environment.

• Occasional opportunities for international and domestic travel.