21 Oct
|
Cygnus Professionals
|
India
21 Oct
Cygnus Professionals
India
Role Description: This is a remote, contract role for a Veeva RIM Specialist with solid experience in SCP (Submission Content Plan) within the pharmaceutical domain, based across Pan India. The specialist will configure, manage, and optimize Veeva RIM to support regulatory submission planning, authoring, review, and lifecycle tracking. Daily responsibilities include creating and maintaining Submission Content Plans, ensuring alignment with regulatory requirements, coordinating with regulatory affairs, clinical, and quality teams, and validating content completeness and accuracy prior to submission. The role involves analyzing and improving regulatory workflows, generating reports and dashboards from Veeva RIM, and supporting inspection/audit readiness activities. The specialist will also collaborate with IT and business stakeholders to troubleshoot issues, support enhancements, and ensure user training and adherence to established governance and compliance standards.
Qualifications:
• Strong hands-on experience with Veeva RIM, including configuration, data management, and workflow optimization for regulatory submissions.
• Proficiency in SCP (Submission Content Plan) creation and maintenance, with practical exposure to eCTD or similar global submission structures.
• Background in pharmaceutical or life sciences regulatory operations, regulatory affairs, or related compliance roles.
• Experience supporting digital transformation initiatives in regulated environments, ideally within Healthcare IT or pharma technology solutions.
• Ability to collaborate with cross-functional teams (regulatory, clinical, quality, IT) and translate business needs into system configurations.
• Strong analytical, documentation, and problem-solving skills, with attention to detail and a focus on data and process integrity.
• Familiarity with governance, risk, and compliance concepts, including inspection/audit readiness and quality management practices.
• Effective written and verbal communication skills, and ability to work independently in a remote, contract setting.
• Bachelor’s degree
📌 Veeva RIM Specialist with SCP(Submission Content Plan) | Pan India Remote | Contract role | Pharma domain needed
🏢 Cygnus Professionals
📍 India