Roles and Responsibilities

• Responsible for writing safety documents intended for submission to regulatory agencies.
• Responsible for writing patient CSR narratives and producing high quality documents
• Practices excellent internal and external customer service
• Good understanding of MS Word for advanced writing techniques
• Address client comments during document lifecycle, manage revisions, and review deliverables with limited mentor oversight prior to releasing to client
• Ensure documents comply with appropriate ICH and regulatory guidelines
• Interact directly and independently with client
• Ability to follow MMS and sponsor processes
• Practices internal and external leadership skills

Job Requirements (Minimum Education / Experience / Training / Skills)

• Experience in CSR narratives and aggregate reports
• University graduate in scientific, medical, clinical discipline or related field, or related experience
• Prior medical/ narrative/ safety writing experience preferred; Interested in expanding knowledge of drug development as it pertains to narrative writing
• Master’s or PhD in a scientific, medical, or clinical discipline preferred
• Min 4 years’ experience with regulated scientific/clinical or pharmaceutical, biotech or clinical research environment 
• Understands ICH guidelines, as applicable to medical writing for clinical studies
• Excellent written English skills
• High degree of organization and able to manage multiple projects at any given time
• Attention to detail and committed to excellence in all aspects of their work
• Excellent communication and interpersonal skills
• Proficient in Microsoft Word and Adobe Acrobat
• Experience in the use of an Electronic Document Management system

Apply through this Link