Senior Manager, Clinical Trial Transparency & Disclosure (Remote) Regulatory and MW - Transpare[...]

MMS Holdings Inc; Michigan; Remote; USD 90,000 - 120,000; Full time

Job summary

A leading clinical research organization is seeking an experienced professional to manage transparency and regulatory deliverables. The ideal candidate will possess strong leadership and communication skills, with a background in clinical trial transparency. Join a collaborative team that values innovation and excellence in clinical research.

Qualifications

• Minimum of 6 years’ experience in clinical trial transparency or medical writing role.
• At least 5 years of experience in a CRO environment.

Responsibilities

• Interact with clients and regulatory authorities, remotely and onsite.
• Manage daily activities and workload of transparency, PLS, and redaction teams.
• Develops and leads teams with diverse experience.

Skills

Leadership

Communication

Analytical Skills

Problem-Solving

Education

Graduate degree in scientific, medical, clinical discipline

Masters preferred

Tools

MS Office

Job description

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-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex 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 collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.comor follow MMS on LinkedIn.

Responsibilities:

• Interact with clients and regulatory authorities, remotely and onsite, including representation at key regulatory meetings on behalf of the client.
• Demonstrated ability to lead/ manage multiple individuals and/or groups.
• Cross-functionally collaborates and coordinates Transparency deliverables ensuring that timelines and milestones remain on-track and within target.
• Strategically assesses resource utilization and forecasting to ensure companywide goals are met
• Effectively communicates complex strategic concepts with ability to tailor message to targeted audience.
• Demonstrate thought leadership with customers by developing and presenting client industry trends, benchmarking, and other pertinent information. May participate in industry events for this purpose.
• Demonstrated ability to lead / manage multiple individuals and/or groups in a global environment.
• Directs strategic planning and proactively prepares contingency plans to address unforeseen challenges within group, and cross functionally to ensure uninterrupted delivery and maintain compliance.
• Ability to facilitate positive group morale and productivity by appropriately including others in decisions/plans.
• Manages staff, makes decisions and advises others on complex problems; understands intra- and inter-departmental implications of decisions and can develop strategic solutions with minimal input.
• Direct, manage, and oversee the daily activities and workload of the transparency, PLS, and redaction teams.
• Proactively identifies areas for improvement before issues arise and provides strategic proposal/resolution for consideration.
• Develops and leads teams with diverse experience and skill sets to achieve intra and inter departmental goals.

Requirements:

• Graduate degree in scientific, medical, clinical discipline or related field, or related 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.