What are the responsibilities and job description for the Aggregate Reports Manager position at 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. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for the last three consecutive years. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.
Internal title for this role is Technical Manager - Safety Writing.
Job Description
- Responsible for the planning, preparation, and submission of high-quality aggregate reports (DSURs, PBRERs, PADERs, etc.) in compliance with global and local regulations and requirements
- Provides leadership and direction to report authors and contributors
- Interactions cross-functionally both internally and externally
- Implements and manages the procedures and tools to ensure high-quality functional deliverables are completed
- Oversees functional specifications of data requirements for aggerate report deliverables from the safety and clinical databases
- Maintains strong understanding of global, regional, and local regulatory reporting requirements as they pertain to aggregate reports
- Practices excellent internal and external customer service
- Good understanding of MS Word for advanced writing techniques
- Ensure documents comply with appropriate ICH and regulatory guidelines
- Interact directly and independently with client and their business partners
Requirements
- 5 Years of experience specifically in Drug Safety Aggregate Reports Management and 8 years' experience in the pharmaceutical industry
- Master’s or PhD in a scientific, medical, or clinical discipline preferred
- High degree of organization and able to manage multiple projects at any given time
- Strong attention to detail and committed to excellence in all aspects of their work
- Excellent oral and written communication and interpersonal skills
- Proficient in Microsoft Word and Adobe Acrobat
- Experience in the use of an Electronic Document Management system
