The RIM contractor is accountable to enter and manage regulatory information for submissions, approvals, and associated product data.
They create and monitor CMC change control for commercial and investigational product.
Create submission content plan to feed in the DCN for CS portal maintenance as well as creating CMC information records to capture new submitted and approved CMC updates for all impacted fields in the RTM tool.
Function as a strong RIM user, interact with global regulatory associates, address questions, and solve problems.
Monitoring data quality, accuracy, and integrity.
Participate in system testing for upgrades by executing scripts and being involved in validation.
Maintains good understanding of the assigned regulatory processes with specific areas of expertise.
Manages daily workload and independently addresses questions for assigned regulatory processes.
Contributes to and helps identify system and process gaps in developed areas of expertise.
At the request of management, prepares data in support of meetings as they relate to developed areas of expertise.
Recognizes and reports data compliance issues and is able to derive how they impact assigned processes and other processes.
Executes operational aspects of assigned regulatory processes according to procedures.
Required Skills:
BS/BA in a relevant scientific or technical field preferred.
Minimum of three years of relevant experience.
Demonstrates critical thinking skills and the ability to apply this to daily workload decisions.
Demonstrates awareness of the procedures and decision-making process of relevant health authorities.
Strong understanding of regulatory operations.
Knowledge of computer systems in an R&D environment.
Basic understanding of electronic records management rules.
Participates in projects and communicates and interacts with internal customers. Practical experience with desktop application software suites.
Proficient in the English language both written and oral, and able to communicate effectively in a written form with non-English speakers.
Good presentation skills.
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Kevin: kevin@alphaconsulting.Com
ALPHA'S REQUIREMENT #23-00385
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
