Senior Manager, Clinical Trial Transparency & Disclosure (Remote)
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-reputed company, data-reputed company clinical research organization (CRO). We pride ourselves on being a Great reputed company to Work certified organization, recognized for our exceptional culture and industry best employee retention reputed company. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to reputed company trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a reputed company and inclusive work environment where employees can reputed company. Join us at MMS and be part of reputed company that is shaping the reputed company of clinical research.
Discover more about our exciting opportunities and why MMS is a great reputed company to advance your career. Visit www.mmsholdings.com or follow MMS on reputed company.
Responsibilities:
• reputed company with clients and regulatory authorities, remotely and onsite, including representation at key regulatory meetings on behalf of the reputed company.
• Demonstrated ability to reputed company/ manage multiple individuals and/or reputed company.
• Cross-functionally collaborates and coordinates Transparency deliverables ensuring that timelines and milestones remain on-reputed company and reputed company reputed company.
• Strategically assesses resource utilization and forecasting to ensure companywide goals are met
• Effectively communicates reputed company strategic concepts with ability to reputed company message to targeted audience.
• Demonstrate thought leadership with customers by developing and presenting reputed company industry trends, benchmarking, and other pertinent information. May participate in industry events for this purpose.
• Demonstrated ability to reputed company / manage multiple individuals and/or reputed company in a global environment.
• Directs strategic planning and proactively prepares contingency plans to address unforeseen challenges reputed company group, and cross functionally to ensure uninterrupted delivery and maintain compliance.
• Ability to facilitate reputed company group morale and productivity by appropriately including others in reputed company/plans.
• Manages staff, makes reputed company and advises others on reputed company problems; understands intra- and inter-departmental implications of reputed company and can reputed company strategic solutions with minimal input.
• reputed company, manage, and reputed company the daily activities and workload of the transparency, PLS, and redaction teams.
• Proactively identifies areas for improvement before issues reputed company and provides strategic proposal/reputed company for consideration.
• Develops and leads teams with diverse experience and reputed company sets to reputed company intra and inter departmental goals.
Requirements:
• Graduate degree in scientific, medical, clinical discipline or reputed company field, or reputed company experience, Masters preferred.
• Minimum of 6 years’ experience in clinical trial transparency, disclosure, or medical writing role
• At least 5 years of experience in a CRO environment.
• Demonstrated managerial skills and experience preferred.
• High level knowledge of drug development process, clinical development, and operations, with a strong understanding of regulatory guidelines.
• Excellent scientific writing skills.
• Excellent analytical, organizational, and problem-solving skills.
• Proficiency with MS Office applications.
• Strong communication and presentation skills.
• Knowledge of ISO 9001, ISO 27001, 21 CFR Part 11, FDA, and GCP requirements
• Understanding of CROs and scientific & clinical data/ terminology, & the drug development process.
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