Regulatory & Medical Affairs - Regulatory Information Management (RIM) Labeling Consultant

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap - Right Talent - Right Time - Right Place - Right Price and acting as a Career Coach to our consultants. Position: RIM Labeling ConsultantLocation: Hybrid Opportunity - Multiple Locations Duration: 6+ Months (Extendable ) Pay Rate: 50.00 - 53.00/hr on W2 Please note this role is 50% onsite (Hybrid). We have opened up flexibility such that candidates that can commute to the following sites will be considered.

• Devens, MA
• Cambridge, MA
• Summit, NJ
• Warren, NJ
• New Brunswick, NJ
• Lawrenceville, NJ
• Princeton Pike, NJ
• Nassau Park, NJ
• Tampa, FL
• Libertyville, IL

Job Description: Title is RIM Labeling Consultant Functional Area DescriptionGlobal Regulatory Business Capabilities In collaboration with the business, sets the strategic business direction for the development and maintenance of systems used in GRS, including responding to any needs for regulatory data from other parts of the BMS enterprise Oversees strategic direction of the data quality programs necessary to achieve and maintain high data quality in GRS systems Establishes and maintains a set of regulatory standards for data and processes in scope Evaluates internal and external requirements and guidance s with impact to BMS compliance and processes, especially where systems are impacted Position Summary / Objective

• The RIM Labeling Consultant is accountable to enter and manage regulatory information (RIM) associated with global labeling.
• Distribute notification of regulatory changes to country regulatory managers for their assessment against the current local label and submission planning.
• Monitor data quality, accuracy and integrity, ensure country-level data is available in a complete, and timely manner
• Run reports to identify issues and analyze data trends. Function as a strong RIM user, interact with global regulatory associates, address questions and solve problems.

Position 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 which includes update to User Guides, Quick Reference Guides and reports for analysis.
• 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 can derive how they impact assigned processes and other processes
• Executes operational tasks for regulatory processes according to RIM procedures and work instructions.

Degree RequirementsBS/BA in a relevant scientific or technical field preferred. Additional experience may be considered in lieu of a degree. Experience Requirements

• Minimum of 3 years of relevant experience

Key Competency Requirements

• 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. Knowledge of Veeva RIM & Vault systems a plus
• Proficiency in Excel functions, Pivot Tables and reports
• Basic understanding of electronic records management rules
• Proficient in the English language both written and oral, and able to communicate effectively in written form with non-English speakers. Good presentation skills

Why work with us - At Net2Source, we believe everyone has an opportunity to lead. We see the importance of your perspective and your ability to create value. We want you to fit in with an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand out with opportunities to have a strategic impact, innovate, and take necessary steps to make your mark. We help clients with new skilling, talent strategy, leadership development, employee experience, transformational change management and beyond. Equal Employment Opportunity Statement:Net2Source is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.#LSC1