Manager, Health Care Compliance (HCC) Program Management - J&J Family of Companies
Horsham, PA
About the Job
Manager, Health Care Compliance (HCC) Program Management - 2406216621W
Description
Johnson & Johnson is currently recruiting for a Manager, Health Care Compliance (HCC) Program Management located in Titusville, NJ or Horsham, PA supporting the North America (NA) and Global Functions (GF) Innovative Medicines teams.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
The Manager, Health Care Compliance Program Management role will be responsible for training, communications, policies and procedures, and the monitoring program to support the larger organizational approach to risk mitigation and compliance program effectiveness to ensure compliance with relevant laws and regulations such as US federal and state anti-kickback and false claims statutes, transactional and compliance reporting, Federal Food, Drug & Cosmetic Act promotional requirements, Foreign Corrupt Practices Act and other anti-corruption laws, and compliance with any government settlements, as applicable. To achieve this, the individual must collaborate with the following HCC teams: North America and Global Functions Health Care Compliance Officers, Compliance & Technology Integrations (CTI), and Global Policy, Training & Communications (GPTC); along with other functional partners and third-party vendors.
Responsibilities:
Training:
Lead the development and implementation of the NA and GF Innovative Medicines HCC training strategy, to include ad-hoc training needs identified through the risk assessment process, new employee on-boarding, periodic training on specialized subjects, and annual refresher training; Serve as primary point of contact with the NA/GF HCC team to:
* Partner with subject matter experts (SMEs) in HCC to create and deliver customized targeted training based on need to train employees/contractors on HCC policies applicable to their role;
* Maintain employee/contractor certification and training attendance records;
* Customize NA/GF Innovative Medicines HCC policies & procedures and education & training materials to reflect local requirements;
* Develop and implement effective evaluation systems to measure training effectiveness in partnership with (GPTC) team;
* Create and maintain risk-based strategic training roadmap/plan to ensure the organization meets all government and industry health care compliance requirements aligned to the NA/GF risk assessment
Communications:
* Lead the development and implementation of the Innovative Medicines communication strategy for policy, training and monitoring initiatives
* Partner with key stakeholders, business communication resources and third parties to shape a culture of shared accountability through business-driven compliance communications.
* Partner with HCC SMEs to create risk-based, targeted communications, provide customer support to training audiences and partner with NA/GF HCC to expedite the delivery, tracking and reporting of communications.
Policy:
* Develop strategy and deploy NA/GF Innovative Medicines HCC policies and procedures in support of government, privacy, legal and company HCC standards, and procedures in partnership with Law Department, HCC, Regulatory, Advertising, & Promotion (RAP) and other functions as needed
* Collaborate with HCC Officers to ensure support of government, privacy, legal and company HCC/RAP standards and procedures to guide compliant business activities.
* Influence NA/GF Innovative Medicines HCC policy alignment, harmonization, simplification, or creation of policies or related resources to support risk mitigation needs.
* Provide project management support on comments to regulatory authorities related to draft guidance.
* Create and maintain a robust work instruction framework for training, communication and policy to enable sustainability of the NA/GF Innovative Medicines HCC compliance program.
Monitoring & Metrics:
* Contribute to and implement NA/GF monitoring strategy in collaboration with HCC Officers, CTI, and Program Management Director using a risk-based approach to ensure compliance with Innovative Medicines policies and procedures.
* Execute a timely monitoring plan. Ensure findings/unplanned deviations are documented in the appropriate systems and corrective action is implemented when appropriate. Create and maintain monitoring metrics package to deliver to NA/GF HCC Officers and senior HCC leaders that provide insights to ensure culture of accountability with business partners.
* Partner with CTI to develop and/or enhance dashboards/tools to advance data analytics and insight generation.
* Implement and maintain systems/tools that collect, audit, analyze, and report training and communications compliance metrics for NA/GF HCC in partnership with GPTC
* Create and/or maintain robust work instructions framework for monitoring and metrics to ensure sustainability of the NA/GF Innovative Medicines compliance program.
Talent/Vendor Management:
* Responsibility for the management of contractors, employees, or co-ops. Provide technical subject matter expertise, ensure efficient and successful onboarding of talent as applicable and ensure all administrative requirements (including purchase order and budget management) are met.
Qualifications
* A Bachelor’s Degree is Required.
* A minimum of six (6) years of business experience required. At least three (3) years of experience and demonstrated leadership in Health Care Compliance, Regulatory Advertising & Promotion, Communications, Sales Learning & Development, Data Science, Data Analytics or Quality & Compliance area
* Broad business experience and a proven ability to influence business decisions and partners.
* Excellent English verbal and written communication skills, including formal presentation skills required.
* Demonstrated experience creating training content, managing eLearning projects, leveraging eLearning tools and applying adult learning principles required.
* Demonstrated experience in data analytics and the ability to concisely and effectively tell the story (verbally and visually) based upon data insights and trends.
* Demonstrated experience in streamlining and/or automating processes.
* Ability to simultaneously manage multiple, complex priorities independently and communicate complex information is required.
* Ability to interact and influence different levels of management in a cross-functional, cross-regional team environment.
* Knowledge of Microsoft Office (Word, PowerPoint, Outlook) and advanced knowledge of Excel and SharePoint are required.
* High standard of work ethic and professionalism to co-workers and customers.
* Self-starter with initiative, the ability to work independently and a proven track record in delivering results is required.
* Some local and domestic travel may be required depending on business need (up to 10%).
PREFERRED -
* Preferred area of study: Organizational Design, Information Management, Data Science/Analytics
* Experience with Power Apps/Power Automate
* Knowledge of: (1) anti-kickback and false claims laws; (2) transactional and compliance reporting laws and regulations; (3) Federal Food, Drug & Cosmetic Act promotional requirements and (4) Foreign Corrupt Practices Act preferred.
* Preferred Related Industry Experience: Project Management Professional certification, Certified Compliance & Ethic Professional certification
* Ability to implement and/or enhance Sharepoint-based websites or effectively use systems/tools to automate processes that reduce manual processes, is preferred.
* Prior experience in the application of web-based reporting tools and website maintenance is preferred.
The anticipated base pay range for this position is $99,000-$170,200. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
* 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)).
* Employees are eligible for the following time off benefits:
o Vacation – up to 120 hours per calendar year
o 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
o Holiday pay, including Floating Holidays – up to 13 days per calendar year
o Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits
This job posting is anticipated to close on October 14, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
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 NA-US-Pennsylvania-Horsham
Organization Johnson & Johnson Services Inc. (6090)
Job Function Health Care Compliance
Req ID: 2406216621W
Description
Johnson & Johnson is currently recruiting for a Manager, Health Care Compliance (HCC) Program Management located in Titusville, NJ or Horsham, PA supporting the North America (NA) and Global Functions (GF) Innovative Medicines teams.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
The Manager, Health Care Compliance Program Management role will be responsible for training, communications, policies and procedures, and the monitoring program to support the larger organizational approach to risk mitigation and compliance program effectiveness to ensure compliance with relevant laws and regulations such as US federal and state anti-kickback and false claims statutes, transactional and compliance reporting, Federal Food, Drug & Cosmetic Act promotional requirements, Foreign Corrupt Practices Act and other anti-corruption laws, and compliance with any government settlements, as applicable. To achieve this, the individual must collaborate with the following HCC teams: North America and Global Functions Health Care Compliance Officers, Compliance & Technology Integrations (CTI), and Global Policy, Training & Communications (GPTC); along with other functional partners and third-party vendors.
Responsibilities:
Training:
Lead the development and implementation of the NA and GF Innovative Medicines HCC training strategy, to include ad-hoc training needs identified through the risk assessment process, new employee on-boarding, periodic training on specialized subjects, and annual refresher training; Serve as primary point of contact with the NA/GF HCC team to:
* Partner with subject matter experts (SMEs) in HCC to create and deliver customized targeted training based on need to train employees/contractors on HCC policies applicable to their role;
* Maintain employee/contractor certification and training attendance records;
* Customize NA/GF Innovative Medicines HCC policies & procedures and education & training materials to reflect local requirements;
* Develop and implement effective evaluation systems to measure training effectiveness in partnership with (GPTC) team;
* Create and maintain risk-based strategic training roadmap/plan to ensure the organization meets all government and industry health care compliance requirements aligned to the NA/GF risk assessment
Communications:
* Lead the development and implementation of the Innovative Medicines communication strategy for policy, training and monitoring initiatives
* Partner with key stakeholders, business communication resources and third parties to shape a culture of shared accountability through business-driven compliance communications.
* Partner with HCC SMEs to create risk-based, targeted communications, provide customer support to training audiences and partner with NA/GF HCC to expedite the delivery, tracking and reporting of communications.
Policy:
* Develop strategy and deploy NA/GF Innovative Medicines HCC policies and procedures in support of government, privacy, legal and company HCC standards, and procedures in partnership with Law Department, HCC, Regulatory, Advertising, & Promotion (RAP) and other functions as needed
* Collaborate with HCC Officers to ensure support of government, privacy, legal and company HCC/RAP standards and procedures to guide compliant business activities.
* Influence NA/GF Innovative Medicines HCC policy alignment, harmonization, simplification, or creation of policies or related resources to support risk mitigation needs.
* Provide project management support on comments to regulatory authorities related to draft guidance.
* Create and maintain a robust work instruction framework for training, communication and policy to enable sustainability of the NA/GF Innovative Medicines HCC compliance program.
Monitoring & Metrics:
* Contribute to and implement NA/GF monitoring strategy in collaboration with HCC Officers, CTI, and Program Management Director using a risk-based approach to ensure compliance with Innovative Medicines policies and procedures.
* Execute a timely monitoring plan. Ensure findings/unplanned deviations are documented in the appropriate systems and corrective action is implemented when appropriate. Create and maintain monitoring metrics package to deliver to NA/GF HCC Officers and senior HCC leaders that provide insights to ensure culture of accountability with business partners.
* Partner with CTI to develop and/or enhance dashboards/tools to advance data analytics and insight generation.
* Implement and maintain systems/tools that collect, audit, analyze, and report training and communications compliance metrics for NA/GF HCC in partnership with GPTC
* Create and/or maintain robust work instructions framework for monitoring and metrics to ensure sustainability of the NA/GF Innovative Medicines compliance program.
Talent/Vendor Management:
* Responsibility for the management of contractors, employees, or co-ops. Provide technical subject matter expertise, ensure efficient and successful onboarding of talent as applicable and ensure all administrative requirements (including purchase order and budget management) are met.
Qualifications
* A Bachelor’s Degree is Required.
* A minimum of six (6) years of business experience required. At least three (3) years of experience and demonstrated leadership in Health Care Compliance, Regulatory Advertising & Promotion, Communications, Sales Learning & Development, Data Science, Data Analytics or Quality & Compliance area
* Broad business experience and a proven ability to influence business decisions and partners.
* Excellent English verbal and written communication skills, including formal presentation skills required.
* Demonstrated experience creating training content, managing eLearning projects, leveraging eLearning tools and applying adult learning principles required.
* Demonstrated experience in data analytics and the ability to concisely and effectively tell the story (verbally and visually) based upon data insights and trends.
* Demonstrated experience in streamlining and/or automating processes.
* Ability to simultaneously manage multiple, complex priorities independently and communicate complex information is required.
* Ability to interact and influence different levels of management in a cross-functional, cross-regional team environment.
* Knowledge of Microsoft Office (Word, PowerPoint, Outlook) and advanced knowledge of Excel and SharePoint are required.
* High standard of work ethic and professionalism to co-workers and customers.
* Self-starter with initiative, the ability to work independently and a proven track record in delivering results is required.
* Some local and domestic travel may be required depending on business need (up to 10%).
PREFERRED -
* Preferred area of study: Organizational Design, Information Management, Data Science/Analytics
* Experience with Power Apps/Power Automate
* Knowledge of: (1) anti-kickback and false claims laws; (2) transactional and compliance reporting laws and regulations; (3) Federal Food, Drug & Cosmetic Act promotional requirements and (4) Foreign Corrupt Practices Act preferred.
* Preferred Related Industry Experience: Project Management Professional certification, Certified Compliance & Ethic Professional certification
* Ability to implement and/or enhance Sharepoint-based websites or effectively use systems/tools to automate processes that reduce manual processes, is preferred.
* Prior experience in the application of web-based reporting tools and website maintenance is preferred.
The anticipated base pay range for this position is $99,000-$170,200. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
* 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)).
* Employees are eligible for the following time off benefits:
o Vacation – up to 120 hours per calendar year
o 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
o Holiday pay, including Floating Holidays – up to 13 days per calendar year
o Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits
This job posting is anticipated to close on October 14, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
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 NA-US-Pennsylvania-Horsham
Organization Johnson & Johnson Services Inc. (6090)
Job Function Health Care Compliance
Req ID: 2406216621W
Source : J&J Family of Companies