Job Description Summary

Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. Has in-depth knowledge of best practices and how own area integrates with others; has working knowledge of competition and the factors that differentiate them in the market.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Job Description

Roles and Responsibilities

• 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
• 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

​Qualifications/Requirements

• BSPharm, Pharm.D., or an equivalent pharmacy degree

• Licensed Pharmacist with 10+ years of experience
• 1+ years of experience in the pharmaceutical industry
• Demonstrated experience and proficiency with the Microsoft Office products (Word, Excel, PowerPoint, Access, Outlook)
• Strong written and verbal communication skills

Desired Characteristics

• Experience with pharmaceutical promotional review

• Experience in Zinc or Veeva 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

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership –always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.

For U.S. based positions only, the pay range for this position is $124,000.00-$186,000.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

Additional Information

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

Application Deadline: January 03, 2025