What are the responsibilities and job description for the CSR Narrative Writer position at MMS?
MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for the last three consecutive years. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.
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
Requirements
- Minimum 3 years' experience writing CSR narratives
- 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
- Experience is independently leading projects and client communication.
- Master’s or PhD in a scientific, medical, or clinical discipline preferred
- Minimum 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
