Senior Manager, Health Care Compliance Officer

Johnson and Johnson; Toronto; On-site; CAD 100,000 - 130,000; Full time

Job summary

A leading healthcare company seeks a Senior Manager, Health Care Compliance Officer in Toronto, Ontario. This role involves overseeing compliance activities, guiding business partners on regulations, and ensuring adherence to healthcare standards, supporting initiatives that drive compliant growth in the healthcare sector.

Qualifications

• Minimum 8-10 years of business-related experience required.
• 5 years in healthcare industry with Health Care Compliance knowledge.
• Bilingual in English and French preferred.

Responsibilities

• Oversee compliance of commercial and medical activities.
• Provide guidance on marketing strategies and materials.
• Lead HCC committee meetings with senior leaders.

Skills

Leadership

Risk Assessment

Data Analysis

Communication

Education

Bachelor’s degree

Job description

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 Job Function : Legal & Compliance Job Sub Function : Health Care Compliance Job Category : Professional All Job Posting Locations : Toronto, Ontario, Canada Job Description : We are searching for the best talent for a Senior Manager, Health Care Compliance Officer to be located in Toronto, Ontario, Canada. Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https : / / www.jnj.com / innovative-medicine. Purpose : The Senior Manager, Health Care Compliance Officer will be responsible for collaborating with the Johnson and Johnson Innovative Medicine business partners and providing strategic compliance guidance on Commercial and Medical Affairs activities and processes that have health care compliance-related implications.

The Health Care Compliance Officer will provide direction and oversight of the Health Care Compliance (HCC) Program for multiple products within Johnson and Johnson Innovative Medicine and ensure the business integrates health care compliance and corporate integrity principles into strategic plans and tactics. You will be responsible for :

• The Senior Manager, Health Care Compliance Officer will serve as a business partner and is responsible for the review, governance, and compliance oversight of commercial and medical activities across the therapeutic area(s) they are assigned.

This includes supporting policies and procedures supporting product promotion including but not limited to marketing strategies and materials, field sales aids, informational brochures, marketing materials, public-relations materials, press releases, sales training documents, internal communications, business plans, field incentive compensation programs, field call plans, and promotional programs.

Additional support will include compliance guidance and oversight of medical activities including business plans, research proposals, IITs, medical educational grants, medical education programs (i.e., sponsorships, advisory boards, congresses) to facilitate compliant growth and ensure that materials comply with company policies and procedures including the Healthcare Regulatory Guidance Documents for Promotional & Marketing Practices, industry standards and applicable laws.

• Responsible for ensuring business activities comply with relevant HCC laws, Canadian laws / regulations and industry standards, and company policies related but not limited to : + Product Promotion : Selling, promotion, compliant launch strategies, and marketing of health care products and services + Fee-For Service and Customer Engagements : Interactions with health care professionals and / or government officials, Fair Market Value support + Counseling, advising and training business partners on relevant laws and regulations as applicable + Transactional and compliance reporting
• Perform risk assessment mitigation process and advising Business Management of potential compliance risk areas and recommended action plans.

This may include being a Team Risk Lead and handling the associated change management for projects that may have global, regional and / or Canadian wide impact.

• Identifying and applying Ways of Working for risk work plans and activities ensuring scientific, non-commercial independence.
• Anticipate potential problems and proactively take appropriate steps.This includes providing business-partnering advice / consult to senior leaders, and proactive outreach to shape compliant business strategies.
• Oversee the creation of appropriate tracking mechanisms based on problem identification; provide clarity around the ambiguities of the evolving HCC environment.This includes leading enhanced monitoring and communicating results to senior leadership.
• Assess compliance-related educational needs, formulate and facilitate compliance training programs for all employees, agents, affiliated providers, or others working with the Business.
• Ensure accountability for compliance through risk assessment, problem identification, oversight & monitoring, investigation and lead follow-ups within relevant HCC processes and systems (e.g., Unplanned Deviations, Corrective Action Plans, and mitigation work plans, etc.).

Summarize / communicate trends and results and recommend risk management strategies to senior leadership.

• Identifying potential HCC, GCC and privacy risks associated with commercial and medical activities and ensuring involvement of appropriate individuals within HCC, Privacy, and Legal to provide appropriate guidance.

In consultation with the Health Care Compliance Officer Director / Sr.

Director, Human Resources, and the Law Department, responsible for ensuring there is a mechanism in place for appropriately disciplining instances of non-compliance and ensuring consistency in the application of disciplinary action.

• The Senior Manager, Health Care Compliance Officer will be accountable for communicating company healthcare compliance standards and information updates on new and relevant laws and guidance to committee members, key business partners and agencies.

This includes leading HCC committee meetings with senior leaders, supporting / leading company-wide compliance culture transformation initiatives, and appropriate internal / external stakeholder management. Qualifications / Requirements :

• A minimum of a Bachelor’s degree is required.
• A minimum of 8-10 years of business-related experience required.
• 5 years of experience in the healthcare industry with knowledge of Health Care Compliance programs and policies, Federal health care programs, and FDA / Health Canada requirements required.
• Consistent track record of working in a collaborative environment with demonstrated evidence of maintaining relationships and partnerships with peers and business partners.
• Demonstrated leadership skills set and a proven ability to influence business decisions and business partners.
• Demonstrated ability to analyze data and trends, and communicate complex information to all levels of the company required.
• Experience working with the governmental regulatory bodies and managing HCC company policies is preferred.
• Demonstrated ability to work independently, cross functionally and collaboratively.
• Excellent written and verbal communication skills.
• Self-motivated, strong project management and decision-making skills.
• Qualified candidates will have an engaging and personable demeanor; be self-directed, detail-oriented, and motivated; demonstrate a high level of accountability, leadership, and decisiveness and the ability to prioritize, and execute on multiple and frequently changing priorities.
• Experience in risk assessment, issue spotting, and risk mitigation preferred.
• Experience developing and implementing one or more elements of a compliance program in accordance with an organization's risk profile is preferred.
• Knowledge of commercial sales, marketing, and Medical Affairs activities for healthcare products.
• Must have experience working and leading in a matrix environment to deliver solutions which drive compliant growth.
• CCEP accreditation preferred.
• Bilingual in English and French preferred.
• This position is located and based in Toronto, Ontario and may require occasional travel to the United States.

Candidate will be expected to be based out of this location and be onsite per company required policies.