Senior Associate, Promotional Operations
Core
Lead the regulatory review department, managing staff and client review processes for pharmaceutical advertising materials.
Role type
Senior Manager, Regulatory Operations
Builds
Regulatory review workflows and client compliance procedures
Domain
Pharmaceutical industry / Healthcare / Advertising
Deliverable
client delivery
Required skills
FDA pharmaceutical advertising regulations, team leadership, client presentation, technical writing, workload management
Preferred skills
Technical writing, process improvement
Technologies
Internet Explorer, Adobe Acrobat, Microsoft Office Suite
Responsibilities
Provide leadership, career guidance and training opportunities for the department staff; Manage multiple direct reports at the Senior Manager, Manager, Associate and Senior Associate level including responsibility for interviewing, hiring, onboarding, and career development; Manage workload across regulatory review department; Work with staffing, recruiting, and individual business managers to determine workload projections to ensure all client needs are met; Escalate potential large issues and concerns to senior leadership; Work with external clients to establish appropriate regulatory review procedures where procedure has previously lacking; Advise external clients on streamlining their reviews; Work with new external clients to uncover and document their review procedures; Contribute to new business development efforts; Train DH personnel on FDA regulations and the MLR review process; Serve as an advocate for the Regulatory Review Department internally and in front of external client