Title: Business Partner - CSM
NJ, US
Job Description
This role acts as the point of contact for assigned brand stakeholders (internal and external). The CSMs are operational experts in promotional material review and approval, working with brands or Review and Approval Operations Leads on timeline planning, launches, label updates, and agreed ad hoc projects with the Indegene Functional Lead.
• Provide brand-level business-as-usual (BAU) operational support for the review and approval of promotional materials, as well as any situation requiring content planning or strategic direction.
• Deliver BAU training and onboarding support to both internal and external stakeholders
• Serve as an operations process expert by offering launch timeline planning and project management for promotional material review and approval processes
• Act as a process expert on label updates and prioritization of critical milestones within projects
• Oversee the RC scheduler for assigned brands to ensure efficient coordination
• Provide assistance and issue resolution for Review and Approval system-related matters
• Promote and facilitate adoption of process enhancements to accommodate updates to Review and Approval policies, systems, and procedures
• Support the implementation of new initiatives introduced by the Content Quality Review and Approval Operations organization
Timeline Management and Brand Planning
• Consult with marketing and agencies on all launch and label update content planning and timeline management (day 0 launch planning)
• Attend brand status and planning meetings with marketing and agency partners
Promotional Material Process Oversight and Management
• Promote brand team adherence to operational effectiveness standards and identify process optimization opportunities
• Work closely with the Commercial team, Review and Approval Committee members, and Content Quality Review and Approval Operations Team to proactively identify and resolve issues and ensure reviews are efficiently completed throughout various stages of the process
• Interact with all relevant internal and external stakeholders, including Agency Partners, Marketing Material Owner, and the Regulatory Submissions team to assist in adherence to all Final Sample submission timelines and policies
• Partner with marketing material owners and other stakeholders in the re-review process, when needed
• Facilitate operational process and timelines for all tactics related to label updates for assigned brands
• Ensure adherence to RC Norms and escalate findings to the Review and Approval Regional Lead for optimization and standardization opportunities
• Day-to-day POC for review and approval system assistance and issue resolution
RC Scheduling and Prioritization
• Oversee and monitor agenda alignment with RC norms across commercial teams, RC members, and Agency Partners.
• Identify agencies or Material Owners frequently missing agreed upon submission timelines, and escalate to the Review and Approval Regional Lead
• Provide RC Facilitation services to assigned brands; perform the RC Captain role in meetings to include, but not limited to, ensuring meeting effectiveness, driving adherence of the review/approval process, ensuring adherence to roles/responsibilities of all stakeholders to align with policy and process, identifying best practices and areas of opportunity, and ongoing feedback to the Review and Approval Regional Lead
Training and Onboarding Support
• Identify and ensure stakeholders receive onboarding and ongoing process, policy, system training with the Review and Approval team for each area
Reports and Audits
• Support any corporate or annual audit processes related to promotional materials
• Run reports to identify all materials/assets that require changes as a result of a label update
Must Have
Requirements
- Excellent interpersonal and collaboration skills
- Project management skills and experience preferred
- General understanding of FDA regulations for pharmaceutical advertising and promotion
- Strong presentation and meeting facilitation skills
- 3-5 years of experience in client engagement, consulting, program management, or service delivery
- Experience working with global biopharmaceutical or healthcare clients
Good to have
EQUAL OPPORTUNITY