Manager, Promotional Compliance

Manager, Promotional Compliance

Hospira
Manager, Promotional Compliance
save others' lives, while shaping your own

Position Summary:
The Manager of Promotional Compliance assures compliance in the timely development, review and release of U.S. promotional labeling. Key responsibilities include monitoring FDA promotional activity, analyzing review workflows, managing QA audits, developing action plans, revising policies and providing training. The manager is the process owner for Promotional Material Review (PMR0993) and associated activities, which are conducted in accordance with FDA regulations and Good Manufacturing Practices (cGMP) standards.

Major Duties and Responsibilitie s:
1. Quality Compliance - Assure compliance of review and approval process for promotional materials. Independently manage the PMR0993 process for receiving, documenting, and tracking projects throughout the development life cycle. Assure materials are in compliance with regulatory laws, corporate policies and guidelines.

2. FDA and Internal Audit - Conduct departmental audit planning, and lead biennially (2 years), QA compliance audits. Negotiate auditor findings, write audit response report, make compliance process improvement recommendations, and ensure identified Corrective and Preventive Actions (CAPAs) are resolved. Provide documentation in response to FDA requests and DDMAC letters.

3. Process Management and Measurement - Develop promotional labeling controls, workflows and operational procedures to assure compliance. Define key performance indicators, continuously measure progress, and identify areas for process improvement to achieve better performance. Manage and implement electronic routing system to ensure process reliability and integrity of documentation.

4. Documentation Management - Develop and maintain an organized, methodical documentation system for communicating, implementing, and managing new and existing process requirements. Write and edit policies and procedures, including Standard Operating Procedures (SOPs) and other guidance. Administer monitoring, auditing and communication of policies and procedures.

5. Training and Education - Develop and deliver appropriate PMR0993 training and education. Customize training content (using existing materials and/or creating new) and delivery methods (written, computer-delivered instruction and/or live presentations) to meet the specific audiences or departments needs. Coordinate, track and manage departmental training records.

What We Need From You :
Qualifications & Experience
• Minimum 7+ years experience in promotional review process, or experience with quality management systems
• Experience interacting with the FDA review divisions and/or DDMAC is a plus
• Experience with writing guidance documents, in developing training programs and in administering monitoring and audit programs
• Ability to influence multi-disciplinary teams and internal experts
• Experience in project management and working in a team-based environment
• Excellent verbal and written communication skills
• Attention to detail, strategic and analytical thinking required
• Bachelor degree is required. MBA is a plus

Why It's a Great Place
Full benefits package offering health/wellness benefits, 401K with aggressive company match and immediate vesting, year end Hospira performance bonuses, tuition reimbursement, flexible spending accounts and much, much more!

What We Are Proud Of
Discover a new kind of career with a new kind of industry leader. Discover Hospira, a specialty pharmaceutical and medication delivery company driven to improve the safety and effectiveness of patient care for millions worldwide. Our story is one of integrity, entrepreneurial spirit, agility, and accountability. It has developed over 70 years defined by rich discoveries, progressive energy, and market-leading positions. Connected by our vision of Advancing Wellness™ through the right people and the right products, each of our more than 14,000 employees worldwide is a vital contributor to our success