(Sr) CSR Narrative Writer - South Africa (Remote)

About 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. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating.

Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide.

MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger. 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 

• 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.
• 1-3 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.