Investigator and Patient Engagement (IPE) Compliance Officer

Job description

Job Description

Requisition ID: 0178190322

The Regulatory Advertising & Promotion Department is recruiting for an IPE Compliance Officer to support Research & Development, Investigator and Patient Engagement team located in Titusville, NJ.

Caring for the world, one person at a time, has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

With $71.9 billion in 2016 sales, Johnson & Johnson is the world's most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. There are more than 265 Johnson & Johnson operating companies employing approximately 126,500 people and with products touching the lives of over a billion people every day, throughout the world. If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer

As the IPE Compliance Officer, you will:

• Be responsible for supporting the investigator and patient engagement programs for the general public developed by Research & Development Investigator & Patient Engagement team (IPE) within Janssen Pharmaceuticals to verify consistency with the U.S. Health Care Compliance Guidance and FDA regulations governing pre-approval promotion

• Review investigator and patient engagement materials involving clinical trial recruitment intended for the general public; partner with IPE to manage and coordinate comments as they relate to such programs; advise on templates and forms of current standardized language; and assist with competitive clinical trial recruitment challenges; partner to solutions to innovative strategies; and work with IPE leaders to drive towards a compliant, efficient and effective review process

• Be responsible for engaging in a variety of tasks and initiatives supporting R&D, including many that call for sound judgment and independent initiative

Desired profile

Qualifications

• A minimum of a Bachelors' degree required. Advanced degree is preferred.

• A minimum of 6 years of Regulatory Advertising & Promotion, Healthcare Compliance, or pharmaceutical-related experience (e.g. clinical trial recruitment, R&D investigator or patient engagement experience) is required.

• Experience partnering with in-house legal department, Healthcare Compliance or Regulatory Advertising & Promotion is a preferred.

• Prior experience interacting with clinical trial research is a plus.

• Familiarity with copy approval and document management systems is preferred.

• Must have strong written and verbal communication skills and the ability to effectively work with cross-functional teams, such as Clinical Development, Regulatory Affairs, and Health Care Compliance.

• Must have strong organizational and planning skills and be detail-oriented.

• Experience of successfully working a heavily matrix organization.

• Strong cross-functional teamwork, collaboration, and proactivity skills required.

• Ability to handle approximately 10% local travel time is required.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location
United States-New Jersey-Titusville-
Organization
Johnson & Johnson (6067)
Job Function
Health Care Compliance
Requisition ID
0178190322