Regulatory Information Management (RIM) Consultant

Company: Eclaro
Location: Bayonne
Posted on: May 28, 2023

Job Description:

Regulatory Information Management (RIM) ConsultantJob Number: 23-01204 Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for Regulatory Information Management (RIM) Consultant for our client in Bayonne, NJ. Eclaro's client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you're up to the challenge, then take a chance at this rewarding opportunity!Position Overview: Accountable to enter and manage RIM data. 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 RIM tool. Function as a strong RIM user, interact with global regulatory associates, address questions and solve problems. Monitor data quality, accuracy and integrity. Participate in system testing for upgrades by executing scripts and being involved in validation.Responsibilities: 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 May be asked to contribute to the resolution of corrective preventive action plans in defined area of expertise At the request of management, prepares data in supports of meetings as they related 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 proceduresQualifications: BS/BA in a relevant scientific or technical field preferred or additional experience may be considered in lieu of a degree 3 years of relevant experienceSkills: 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 language, both written and oral, and able to communicate effectively in written form with non-English speakers. Good presentation skills. If hired, you will enjoy the following Eclaro Benefits: 401k Retirement Savings Plan administered by Merrill Lynch Commuter Check Pretax Commuter Benefits Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro If interested, you may contact: June Binuyajunethel.binuya@eclaro.com 2128047476June Binuya - LinkedIn Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.PDN-991b2d9a-eac4-40f5-90d4-34f979512616

Keywords: Eclaro, Bayonne , Regulatory Information Management (RIM) Consultant, Executive , Bayonne, New Jersey