MMS is at the forefront of innovation as a data-centric Clinical Research Organization (CRO) dedicated to empowering the pharmaceutical, biotech, and medical device sectors. We employ a robust scientific framework to navigate the complexities of trial data and regulatory submissions. Our extensive industry expertise, combined with cutting-edge technology and a data-driven methodology, positions MMS as a preferred CRO partner. We pride ourselves on delivering impactful submissions that adhere to stringent regulatory standards. With a presence across four continents and a remarkable 97 percent customer satisfaction rating, MMS has been consistently honored as a premier CRO by Global Health & Pharma’s international awards for three consecutive years. Discover more about us and connect with us on LinkedIn to learn about our journey.

Key Responsibilities:

• Work independently to meticulously evaluate and interpret medical literature, selecting essential resources to ensure study designs incorporate scientific rigor, statistical significance, and objectivity.
• Craft and refine a wide array of clinical development documents, including clinical protocols, investigator brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, and various Module documents, alongside presentation materials and publications for medical journals.
• Ensure all writing assignments are completed punctually while managing timelines and workflows effectively.
• Deliver exceptional internal and external customer service.
• Demonstrate advanced proficiency in writing regulatory documents in various styles.
• Exhibit expert-level knowledge of client templates and style guidelines.
• Collaborate directly with clients to oversee all project components, showcasing strong communication skills throughout.
• Actively contribute to or manage the creation of interpretive guides.
• Take charge of assignments, proactively consulting with project team members and departmental representatives for any necessary information and guidance.
• Mentor fellow medical writers and project team members involved in the writing process.

Qualifications:

• A Bachelor’s, Master’s, or PhD in a scientific, medical, clinical, or related field is essential, with a minimum of 6 years of regulatory writing experience; a Master’s or PhD is preferred.
• Proven experience as a lead author on clinical study protocols is required.
• Demonstrated ability to lead and manage teams while authoring regulatory documents under tight deadlines.
• Familiarity with regulatory submissions, particularly clinical study reports presented to regulatory bodies, is advantageous.
• Strong understanding of clinical data and exceptional writing prowess are mandatory.
• Excellent organizational capabilities and multitasking skills are key.
• Proficient in MS Word, Excel, PowerPoint, and comparable word processing applications.
• Experience as a project lead or managing a project team is beneficial.
• A solid understanding of federal regulations, Good Clinical Practices, and ICH guidelines is a plus.
• While not mandatory, experience with orphan drug designations and PSP/PIPs is an added advantage.

Join us at MMS, where your expertise will contribute to shaping the future of clinical research and making a meaningful impact in the health industry!