Compliance program manager job description

With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the leading company solely dedicated to skin and advancing the future of dermatology.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients and the healthcare professionals we serve every day. We aim to empower each employee and to promote their personal growth all the while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create unparalleled, direct impact.
Job Description

Essential Functions

Location: Onsite/Dallas TX

Partner with multiple Business Units and assist in the implementation of initiatives to ensure compliance with the company's compliance manuals, OIG Guidance for Pharmaceutical Manufacturers, the PhRMA Code on Interactions with Healthcare Professionals, the AdvaMed Code, the Food Drug and Cosmetic Act (FDA), the Physician Payments Sunshine Act, and other state and federal laws and regulations Work closely with the Head of U.S. Compliance to resolve highly complex ethics and compliance matters and identify compliance risks
Work closely with the Head of U.S. Compliance and other U.S. Compliance team members on rolling out, driving and adopting global campaigns and initiatives within the U.S. Region Serve as an integral participant in the U.S. Global Risk Compliance Council and participate as an active member of the Global Legal & Compliance organization
Monitor and audit compliance systems and provide periodic assessments and reporting based on the U.S. risk assessment and reporting obligations to the Global Risk & Compliance Committee
Provide transactional monitoring and follow through with coordination of third-party vendors
Stay informed of changes in applicable rules, regulations, standards and related trends and advise senior leadership of these changes Review and draft policies and standard operating procedures Create and administer compliance training throughout the company along with support from the Global Compliance organization
Serve as lead for all State and Federal filings relative to transparency laws; Provide data integrity review leading to State and Federal filings relative to obligations related to transparency
Drive special projects relative to systems integrations with coordination involving the Global Compliance organization
Assist in follow-through for concerns raised by the Global Compliance Integrity Line, known as Speak Up
Other duties as assigned

Minimum Education, Knowledge, Skills, and Abilities

Bachelor's Degree required JD (or international equivalent) preferred Eight (8) or more years of legal or compliance experience with strong knowledge and understanding of U.S. healthcare compliance and broader legal and regulatory framework highly desired Previous experience with a pharmaceutical, medical device, or biotech company or within a law firm environment working on compliance issues is preferred, though willing to consider exceptional candidates without this experience Strong technical and Quantitative experience, manages aspects of reporting
Experience in a heavily regulated industry is required, and experience with regulations applicable to the pharmaceutical and medical device industries ideal Excellent verbal and written communication skills, including strong presentation skills Reputation for the highest integrity and ethical standards Excellent qualitative and quantitative analytical skills to identify and solve a wide range of business problems Ability to interact and partner effectively with senior management and associates at all levels within the organization Ability to manage multiple priorities and meet deadlines in a fast-paced work environment Ability to effectively manage conflict and other challenging situations Ability to work with cross-functional teams and engage in direct conversations across the organization Self-starter who can lead projects independently from inception to completion with minimal supervision Ability to identify potential compliance and business issues and propose solutions to management Strong attention to detail and strong organizational skills Excellent influencing and negotiating skills Experience working in a highly matrixed, global organization Employer's Rights:

This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based upon your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not a contract for employment, and either you or the employer

We are looking for a Privacy & Compliance Program Manager. They will partner across functional teams to analyze business requirements, build and manage project plans, identify and solve problems and remove roadblocks, and drive the execution of project goals and deliverables.
Responsibilities:

Partner with cross-functional stakeholders, subject matter experts, and functional teams to identify critical issues, solve problems, and design and deploy scalable business processes Analyze data and processes to identify issues that may have the same underlying cause and use evidence-based analytical thinking to verify the relationships between issues and develop practical solutions to fixing the underlying root cause Gain a holistic understanding of the end-to-end processes to effectively develop, document, maintain, and share required project management artifacts, including project plan, schedule, RACI matrix, and communication summaries using standard project management tools Manage project plans and timelines, ensure project roles and responsibilities are clear, and drive execution across all workstreams Facilitate process mapping exercises to analyze and document existing and new processes, highlight gaps, risks, and areas for improvement


Requirements:

5+ years of experience managing complex, cross-functional programs; experience with Privacy & Data Security a plus Skilled in building process maps, flow diagrams, presentations, and visualizing complex themes Skilled with Smartsheet, Lucidchart, Confluence, and the Microsoft Office suite


Pay range is $50-$60/hr depending on experience



Benefits
: Click here to learn more about benefits available to Eastridge s temporary employees. From time to time Eastridge s clients may offer additional benefits to Eastridge employees while on assignment. Information about those benefits will be communicated when applicable.

Eastridge Workforce Solutions is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We celebrate diversity and are committed to creating an inclusive environment for all employees. Please note that Eastridge is unable to provide visa sponsorship to applicants.

We value diverse experiences, including prior contact with the criminal legal system, and applicants with criminal histories are encouraged to apply. Certain clients require Eastridge to perform background checks and Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring, the San Francisco Fair Chance Ordinance, and the Philadelphia Fair Criminal Record Screening Standards Ordinance (a copy of the notice of rights under the Philadelphia Ordinance is available by clicking on this link).

The Program Manager, Clinical Regulatory Compliance & Accreditation works directly with staff and management, coordinates and performs day to day activities related to accreditation and regulatory compliance across all Dana-Farber sites and supports other initiatives in the Quality and Patient Safety Department. The Program Manager, Clinical Regulatory Compliance & Accreditation will also play a critical role in coordinating the regulatory steering committee (CRL).

Under the supervision of the Director for Clinical Regulatory Compliance, the Program Manager, Clinical Regulatory Compliance & Accreditation will support various initiatives in the areas of clinical regulatory compliance. Examples include data analysis and reports to meet the regulatory requirements of The Joint Commission (TJC), Department of Public Health (DPH), and the Centers for Medicare and Medicaid Services (CMS). This role will collaborate with the leaders of committees and task forces at DFCI, BWH and BCH, to assure coordination and consistent documentation of action plans and follow up activity.

Located in Boston and the surrounding communities, Dana-Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow's physician/researchers; we reach out to underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

Leads technical support for regulatory and accreditation compliance, including coordination of Joint Commission survey readiness (pre and post survey follow up), shepherding action plans associated with the submission of the Focused Standards Assessment tool (annual), and conducting related educational programs and patient tracers.

Supports the Director in managing regulatory and accreditation compliance initiatives. Identifies major phases, implementation steps, key stakeholders, timelines, resource needs and potential obstacles or issues for escalation.

Responsible for coordination of accreditation committee (CRL), including assignment of Joint Commission readiness for each member.

Evaluates the impact of new regulatory requirements as they are released and prepares summaries, recommendations, and actions plans as relevant. Directs implementation of new regulatory requirements and surveys as they arise, actively supporting staff throughout the Institute.

Compiles Joint Commission readiness reports for the purpose of senior level reporting. Presents data and analyses to key stakeholder groups independently, as requested.

Staff and attends various ad-hoc and standing committees to assure support, discussion, documentation, and general awareness of current, emerging, and other regulatory changes.

Implementation of a system to notify clinical/non-clinical and management staff of current, emerging and ongoing Joint Commission and other regulatory changes.

Prepares readiness synopses and prepares recommendations for prioritization of decisions to Institute Leadership.

Coordinates and leads formal education programs to a variety of constituencies across the Institute, regarding compliance expectations, feedback on readiness efforts, strategies for success and communication strategies.

Manages development of tools, learning aids, standard reports, and monitoring plans to promote compliance with standards. Conducts tracing activities and document reviews.

Liaison to various departments within DFCI and the satellite network to assure ongoing regulatory compliance.

Maintains relevant project data and conducts related analysis, pulling results into meaningful reports and presentations on an ad-hoc basis.
Performs routine audits of records and observes workflows to ensure policy compliance. Leads policy and procedure review of inpatient policies. Performs all other related duties as required.
Bachelor's degree required; master's degree preferred, preferably in public or health management or the sciences. 3 years of experience in a healthcare organization required; preferably in a related position. Proficiency in IBM PC systems and applications including Excel, PowerPoint, and other database management software required. Data management and analytic system experience preferred.
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
Knowledge of current issues in the healthcare environment preferred, particularly regarding quality measurement, regulatory compliance, and patient safety. Demonstrated project management skills and experience. Excellent organizational skills with a strong focus upon managing details. Exceptional written and oral communication abilities. Strong analytical and critical thinking skills. Ability to anticipate, quickly address and make correct decisions in a fast-paced, dynamic environment. Ability to focus on multiple projects and re-establish priorities as necessary Ability to work effectively with clinical, operational, and IT staff Desire and ability to train and mentor team members Ability to facilitate and work within a complex, multi-site environment.
Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission At to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.
Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.