[Hiring] CSR Narrative Writer @MMS

Role Description

• 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.

Qualifications

• Experience in leading complex CSR narratives projects, preference for Oncology background.
• College 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.
• 2-3 years’ experience with regulated scientific/clinical or pharmaceutical, biotech or clinical research environment.
• Understands ICH guidelines, as applicable to 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.

Requirements

• Should you not have received a response within 14 days of your application, please consider your application unsuccessful.