Job Title : Senior Specialist, RIM
Location: Hyderabad (Hybrid)
Keywords : RIM, Veeva Vault, Labelling
Position Summary
Regulatory Information and Submission Management is an organization that delivers Health Authority submissions and product data to support the BMS portfolio and sets the strategic business direction and related processes oversight for GRS systems. The RIM Senior Specialist will be responsible for planning, tracking, and monitoring regulatory activities and data compliance in the BMS Regulatory Information Management system. The RIM Senior Specialist will work regularly with internal BMS teams to ensure that data in the system is entered in a complete, accurate, and timely manner.
Key Responsibilities
- Upload health authority correspondence into BMS's RIM system including the required metadata.
- Create Health Authority queries in RIM and track to closure. Ensures the correct keywords and submission/ correspondence linkages are established in RIM.
- Create Commitment records in RIM and send workflows/reminders to users on a regular basis. Responsible for contacting users when data quality findings are identified and ensures issues are corrected.
- Create and distribute global CMC Change Controls and IMP Amendment events for commercial and investigational products. Issue workflows in RIM to request assessments and submission planning. Send reminders, as needed, and track the events to closure.
- Create and distribute global Labeling Change Control events. Issue workflows to request assessments and submission planning. Send reminders, as needed, and track the events to closure.
- Perform data quality checks on Labeling Events which drive reporting to the BMS Labeling Office. Send routine reminders to local markets to correct labeling data quality findings identified through RIM reports. Summarize and track issues.
- Create Investigator Brochure events in RIM and close out events as requested.
- Create Marketing and Investigational registrations and update as needed, based on information gathered through RIM reports.
- Work autonomously with local markets to troubleshoot and resolve issues. Provide user support and address questions as needed.
- Prompt attention to business-critical activities to ensure compliance and appropriate documentation of regulatory approvals.
Qualifications & Experience
- BA/BS degree, science / technology field preferred
- 2-4 years pharmaceutical experience; 1+ year of regulatory operations experience
- Proficient knowledge of global regulatory practices and regulatory operations
- Knowledge of regulatory information management and submission guidelines and requirements
- Knowledge of various types of health authority interactions, including HA correspondence, HA queries and HA commitments
- Experience and knowledge in regulatory information management software and computer systems (Microsoft Office, Outlook, eCTD viewers and web based applications) and technically skilled with such systems.
- Communicates questions and issues as they arise with possible solution
- Supports other functions as appropriate
- Effective written and verbal communication skills
- Works with supervision
- Ability to prioritize and strong attention to detail
- Experience instructing/ training end-users
- Experience in the development of work instructions and quick reference guides
- Communication and change management skills
