The Advertising & Promotion Review Leader provides direction to the business regarding regulatory activities for review and approval of promotional activities and marketing materials for all marketed drug product in the US & Canada. This position will provide input into the global organization for labeling strategies of marketed drugs; demonstrate significant autonomy in carrying out assigned duties and responsibilities; and liaise with FDA as needed. **Can work remote but we prefer east coast based. Must be able to travel to Marlborough, MA offices when required (ciritical meetings).
Directs and conducts regulatory reviews and approvals of promotional materials and marketing activities
Ensures on-time and accurate submission of promotional materials to regulatory agencies
Serves as internal regulatory expert on FDA regulations, guidance and enforcement trends governing the promotion of prescription drugs
Provides regulatory leadership and expertise to the respective cross-functional teams that review promotional materials in compliance with applicable regulations and guidance
Reviews and assesses proposed promotional materials to evaluate their completeness, accuracy and compliance with applicable regulations and procedures; reviewing and revising regulatory policies and procedures to ensure compliance with applicable regulations
Serves as primary contact leading and facilitating communications with regulatory agency reviewers in the request and negotiation of advisory comments and any other interactions regarding use of promotional claims for assigned products, including pre-clearance of launch materials or materials requiring pre-clearance, as applicable
Assists teams with the planning of proposed promotional materials and disease state materials
Maintains a thorough understanding of the FDA Office of Prescription Drug Promotion (OPDP) requirements (and other regulatory agency related departments, as appropriate)
Maintains up-to-date knowledge and understanding of current FDA and Health Canada regulatory and advertising and promotional compliance requirements
Ensures the management and maintenance of records and databases that support communication with OPDP and record keeping of submissions and related materials
Performs other duties as assigned
Aware of and complies with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type / position
Complete all planned Quality & Compliance training within the defined deadlines.
Identify and report any quality or compliance concerns and take immediate corrective action as required.
Bachelor's Degree and 5 years’ experience in the pharmaceutical industry, with at least 3 years’ progressive experience in Regulatory Affairs promotional review.
Minimum of 2 years’ experience of regulatory project management and regulatory agency interactions
Experience of working globally or across different cultures
Demonstrated experience and proficiency with the Microsoft Office products (Word, Excel, PowerPoint, Access, Outlook)
Strong written and verbal communication skills
Experience in Zinc software application is a plus
Assertive and willing to make decisions
Ability to assign clear priorities
Ability to juggle multiple competing task and set clear priorities
Organized and delivery focused
Strong negotiation and decision-making skills
Ability to make sound business judgments
Ability to work independently in fast-paced environment with little supervision.
Team-oriented and responsive to customer needs.
Attention to Detail and Results-Oriented.
Ability to understand technical documentation and execute associated procedures.
Telecommuting is allowed.
Internal Number: 3356701
About GE Healthcare
As a leading global medical technology and life sciences company, we provide a broad portfolio of products, solutions and services used in the diagnosis, treatment and monitoring of patients and in the development and manufacture of biopharmaceuticals.We help improve outcomes for healthcare providers and for therapy innovators around the world. This means increased capacity, improved productivity and better patient outcomes.We also aim to support our customers in the pursuit of precision health: health care that is integrated, highly personalized to each patient’s needs and that reduces waste and inefficiency.We embrace a culture of respect, transparency, integrity and diversity.