Medical Writer

Job Description:

Responsibilities

• Ability to use scientific knowledge and writing skills. Should have experience in advanced scientific medical/clinical writing.

• To accomplish primary goal of clear and compliant writing for protocols using templates accepted by the FDA or EMA.

• Assist in compiling, writing, and editing clinical documents covering all phases of clinical research for submission to regulatory agencies.

• Assisting in completing assigned documents according to agreed-upon timelines and follows up with the study team as needed to meet internal and external timeline commitments, and to ensure SOP and regulatory compliance.

• Understands the functions and roles within the study clinical operation and data management teams.

Qualification & Experience

• Master’s Degree (Pharmacy, Medicine, Life Science) with minimum 4 to 6 years of experience in writing of regulatory clinical documents such as clinical study reports, investigators brochures, annual summary documents, integrated summary reports and other documents covering interpretation and documentation of clinical data. Preferably have developed scientific research methods and scientific writing skills.

• Proficiency in written and spoken English at a professional level.

• Have a flair for, and a genuine interest in clinical communication.

• Proficiency in MS Office; additional Certification in MS-Office or Microsoft Office Specialist (MOS) certification will be an asset.

• Good Analytical Skill, Attention to detail, Confidentiality and Effective communication skills.

• Awareness of all relevant regulations, including ICH-E3, and ICH-E6.