Are you eager to contribute to a dynamic organization where your efforts are valued, and teamwork is paramount? Look no further than MMS, an esteemed, data-centric clinical research organization (CRO) renowned for its commitment to excellence. We are proud to be recognized as a Great Place to Work certified company, reflecting our outstanding workplace culture and remarkable employee retention rates. As we cater to the pharmaceutical, biotech, and medical device sectors, we utilize our extensive experience to navigate the complexities of trial data and regulatory submissions. With a presence across four continents, MMS consistently achieves top-tier customer satisfaction while cultivating a collaborative and inclusive environment where our employees can excel. Join us at MMS, where you can play a pivotal role in revolutionizing the landscape of clinical research.

Discover what makes MMS an incredible place to elevate your career. Learn more about our opportunities by visiting us or following MMS on LinkedIn.

Core Responsibilities:

• Engage with clients and regulatory authorities, both remotely and in-person, representing our clients at essential regulatory meetings.
• Exhibit leadership capabilities by managing multiple teams and fostering cross-functional collaboration.
• Oversee and coordinate Transparency deliverables, ensuring all timelines and milestones align with organizational goals.
• Strategically evaluate resource allocation and forecasting to meet key objectives across the company.
• Communicate intricate strategic concepts effectively, tailoring messages to suit specific audiences.
• Demonstrate thought leadership by presenting client industry trends, benchmarking data, and other relevant insights, potentially participating in industry events.
• Lead and manage diverse teams in a global context, ensuring seamless operational execution.
• Drive strategic planning and develop contingency plans to navigate unforeseen challenges, ensuring ongoing compliance and delivery.
• Foster a positive team dynamic and productivity by inclusively engaging team members in decision-making processes.
• Oversee staff performance, address complex problems autonomously, and implement strategic solutions that consider cross-departmental implications.
• Direct the daily functions and workload of the transparency, PLS, and redaction teams.
• Anticipate areas for improvement proactively and propose strategic solutions to enhance processes.
• Guide teams with varied skill sets to achieve departmental and organizational objectives.

Qualifications:

• A graduate degree in a scientific, medical, or clinical discipline, or equivalent experience; a Master’s degree is preferred.
• A minimum of 6 years’ experience in clinical trial transparency, disclosure, or a medical writing role.
• At least 5 years in a CRO environment is essential.
• Proven managerial experience is highly desirable.
• A deep understanding of drug development processes, clinical operations, and relevant regulatory guidelines.
• Exceptional scientific writing capabilities are a must.
• Demonstrable analytical, organizational, and problem-solving expertise.
• Proficiency in MS Office applications is required.
• Strong communication and presentation skills are essential.
• Knowledge of ISO 9001, ISO 27001, 21 CFR Part 11, FDA, and GCP requirements is advantageous.
• Familiarity with CRO operations and scientific and clinical terminologies, as well as the drug development lifecycle, is necessary.

Join us in making a substantial impact in clinical research and take the next step in your career with MMS!