Compliance Management Lead

at J&J Family of Companies in Springfield, Illinois, United States

Job Description

Compliance Management Lead – 2406202095W

Description

Johnson & Johnson Medical Device a member of the Johnson & Johnson Family of Companies is currently recruiting for a Compliance Management Lead ! This position can be performed globally with a preference for North America. Remote work may be considered on a case-by-case basis and if approved by the business.

The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.

Essential Job Duties and Responsibilities

Responsible for overseeing and managing the compliance monitoring process, including metric generation and trending, associated with market research, patient support programs and non-interventional studies to ensure adherence to relevant laws, regulations, industry standards and Company policies/procedures. This role will also supervise operational and management activities related to audit/inspections, including preparatory activities, to ensure that relevant processes are in a constate state of audit/inspection readiness.

+ Oversee the implementation and management of the compliance program, including risk assessments, internal controls, and compliance monitoring activities for market research, patient support programs and non-interventional studies.

+ Use, analyze, and leverage data to make/take informed decisions and to improve/simplify existing processes/systems and/or prevent noncompliance.

+ Provide advice and guidance to Activity Owners and other relevant stakeholders on necessary actions to achieve regulatory compliance, addressing any issues arising from trending analysis and/or audit/inspection findings.

+ Ensure that results of compliance monitoring/trending analysis are communicated per established procedures

+ Oversee and conduct internal investigations into compliance-related issues. Develop and implement corrective actions and remediation plans to address identified compliance gaps or non-compliance.

+ Identify potential compliance risks within the organization and develop strategies to mitigate and manage those risks. Implement risk assessment processes and controls, and develop risk mitigation plans

+ Establish and direct processes related to audit/inspection readiness and for supporting the conduct of the audit/inspection as it relates to market research, patient support programs and non-interventional studies. Ensure timely and accurate responses to audit/inspection requests

+ Continually improve the compliance monitoring systems and processes, with a focus on operational efficiency and being able to proactively prevent non-compliance in partnership/collaboration with key stakeholders

+ Develop, update, and maintain compliance-related policies and procedures. Ensure that they are communicated throughout the organization and regularly reviewed for effectiveness and relevance

• Provide training and development opportunities to team members to enhance their skills and knowledge.

• Set performance expectations, provide regular feedback, and conduct performance evaluations to motivate and support team members in meeting their objectives

• Foster a positive team culture, encourage collaboration among team members and external stakeholders, and resolve conflicts to create a cohesive and high-performing team.

+ Facilitate effective communication within the team and between relevant functions within J&J Innovative Medicine, ensuring that stakeholders are well-informed about goals, changes, and developments

+ Perform related duties as assigned by supervisor.

+ Maintain compliance with all company policies and procedures.

Qualifications

Education:

A minimum of a Bachelors or equivalent University degree is required with a focus in Science, Engineering or technical subjects preferred.

Required:

• Minimum of 8 years pharma experience and 5 years in a management role

• Extensive experience in compliance management

• Strong knowledge of relevant laws, regulations, and industry standards

• Excellent understanding of risk management principles and practices

• Strong leadership and people management skills

• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.

• Excellent computer proficiency e.g MS Office, SAP

• Excellent analytical skill to identify gaps and root causes of issues, and think out of the box to develop a solution.

• Must be able to work independently with minimum supervision to meet tight deadlines, and maintain a positive attitude.

Preferred:

• Individual Case Safety Report operational experience

Other:

• This position may require up to 10% domestic & international travel

• This position has an estimated annual salary of 118,000- 236,000 USD$

+ Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

+ Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

+ This position is eligible to participate in the Company’s long-term incentive program.

+ Employees are eligible for the following time off benefits:

+ Vacation – up to 120 hours per calendar year

+ Sick time – up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year

+ Holiday pay, including Floating Holidays – up to 13 days per calendar year

+ Work, Personal and Family Time – up to 40 hours per calendar year

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

• Primary Location NA-US-New Jersey-Titusville

Other Locations North America, Asia Pacific, Europe/Middle East/Africa

Organization Janssen Pharmaceuticals, Inc. (6062)

Travel Yes, 10 % of the Time

Job Function Customer/Commercial Quality

Req ID: 2406202095W