6,265 Clinical Data Management Lead jobs in the United States
Regulatory Compliance Director
02446
Dana-Farber Cancer Institute
Posted 4 days ago
Job Viewed
Job Description
The Regulatory Compliance Director is a key part of the Compliance team, collaborating across all areas of the organization with a focus on creating a culture of trust and ethical conduct and promoting detection and prevention of conduct that does not align with DFCI's ethical standards, federal and state healthcare laws, payer requirements and internal policies. The Regulatory Compliance Director is responsible for developing, implementing, and overseeing a comprehensive regulatory compliance program across the Institute. This role ensures that all operations, including clinical, research, and administrative functions, adhere to federal, state, and local regulatory requirements. The Director collaborates with multidisciplinary teams to assess regulatory risks, develop and update policies and procedures, and manage and maintain continuous readiness and compliance. The Regulatory Compliance Director will report directly to the Chief Compliance Officer.
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
Regulatory Compliance
+ Provide subject matter expertise on federal, state, and local regulatory requirements (e.g., CMS compliance, Stark and Anti-Kickback laws, physician compensation). Provide expert compliance guidance to leadership, staff, and stakeholders.
+ Monitor changes in regulatory requirements, assess their impact on organizational practices, and provide actionable compliance guidance to stakeholders to ensure adherence.
Policy and Procedure Development
+ Oversee the development, maintenance, and communication of compliance-related policies and procedures to ensure they are up-to-date and aligned with current laws, regulations, and best practices. Revise and adapt organizational policies and practices to reflect changes in regulatory requirements and industry standards.
Audit, Monitoring, and Risk Management
+ Lead and coordinate regulatory audits, inspections, and surveys conducted by agencies (e.g., HHS OIG, CMS) and oversee internal and external audits related to compliance matters. Develop monitoring tools, perform periodic reviews, and collaborate with departments to identify compliance risks and implement corrective action plans.
Training and Education
+ Develop and deliver training programs on regulatory compliance topics to promote a culture of compliance and ethical conduct across the organization.
Stakeholder Collaboration and Communication
+ Serve as a liaison between compliance, legal, operations, and clinical leadership teams to foster transparency, responsiveness, and collaboration. Maintain compliance performance reporting and metrics and communicate effectively with stakeholders to ensure accountability and transparency.
Team Leadership and Development
+ Mentor, develop the compliance team, fostering a culture of integrity, collaboration, and respect. Perform other duties as assigned to support the growth and maturity of the Compliance Program.
+ Bachelor's Degree, JD, or MPH required.
+ Certification in Health Care Compliance (CHC) preferred. Willingness to obtain certification within the first 12 months of employment.
+ Seven to ten years of experience in regulatory healthcare compliance required.
+ Three years in a leadership role required.
**KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:**
+ High ethical standards and commitment to compliance.
+ Ability to interpret and apply complex regulatory requirements to organizational policies and procedures.
+ Knowledge of and experience in working with federal and state research and healthcare compliance laws, regulations and sub-regulatory guidance preferred.
+ Demonstrated proficiency in applying compliance and ethics standards in complex health care environments.
+ Commitment and ability to:
+ Work in a team-based environment,
+ Manage patient and highly reputable faculty and interactions/communication with extreme care, patience, confidentiality, and consideration, and
+ Maintain an environment with open channels of communication within the Institute with workforce members, patients, and others.
+ Possess excellent organization, attention to detail, technical and analytical skills. Can gather relevant information systematically, break down problems into essential components and can make sound decisions. Approach problems with curiosity and open-mindedness and offer new ideas, solutions and/or options. Demonstrate discretion, diplomacy, and good judgment.
+ Possess effective communication and presentation skills, clearly and concisely express ideas in groups and one-to-one conversations, formal and informal documents. Adapt strong writing and communications styles to fit the audience.
+ Self-starter, positive attitude, ability to work independently, enjoys learning and staying current with industry developments, regulations, and best practices.
+ Demonstrate knowledge in setting and achieving challenging goals.
+ Adaptability to a fast-paced environment
+ Ability to thrive in a dynamic work setting, balancing multiple responsibilities while maintaining effectiveness.
+ Strong interpersonal skills to foster a collaborative team environment.
**Pay Transparency Statement**
The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate's relevant experience, skills and qualifications.
For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA)
$163,100 - $186,700
At 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 to reduce the burden of cancer for all, we are committed to having faculty and staff that offer multifaceted experiences. 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 characteristics protected by law.
**EEOC Poster**
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
Regulatory Compliance
+ Provide subject matter expertise on federal, state, and local regulatory requirements (e.g., CMS compliance, Stark and Anti-Kickback laws, physician compensation). Provide expert compliance guidance to leadership, staff, and stakeholders.
+ Monitor changes in regulatory requirements, assess their impact on organizational practices, and provide actionable compliance guidance to stakeholders to ensure adherence.
Policy and Procedure Development
+ Oversee the development, maintenance, and communication of compliance-related policies and procedures to ensure they are up-to-date and aligned with current laws, regulations, and best practices. Revise and adapt organizational policies and practices to reflect changes in regulatory requirements and industry standards.
Audit, Monitoring, and Risk Management
+ Lead and coordinate regulatory audits, inspections, and surveys conducted by agencies (e.g., HHS OIG, CMS) and oversee internal and external audits related to compliance matters. Develop monitoring tools, perform periodic reviews, and collaborate with departments to identify compliance risks and implement corrective action plans.
Training and Education
+ Develop and deliver training programs on regulatory compliance topics to promote a culture of compliance and ethical conduct across the organization.
Stakeholder Collaboration and Communication
+ Serve as a liaison between compliance, legal, operations, and clinical leadership teams to foster transparency, responsiveness, and collaboration. Maintain compliance performance reporting and metrics and communicate effectively with stakeholders to ensure accountability and transparency.
Team Leadership and Development
+ Mentor, develop the compliance team, fostering a culture of integrity, collaboration, and respect. Perform other duties as assigned to support the growth and maturity of the Compliance Program.
+ Bachelor's Degree, JD, or MPH required.
+ Certification in Health Care Compliance (CHC) preferred. Willingness to obtain certification within the first 12 months of employment.
+ Seven to ten years of experience in regulatory healthcare compliance required.
+ Three years in a leadership role required.
**KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:**
+ High ethical standards and commitment to compliance.
+ Ability to interpret and apply complex regulatory requirements to organizational policies and procedures.
+ Knowledge of and experience in working with federal and state research and healthcare compliance laws, regulations and sub-regulatory guidance preferred.
+ Demonstrated proficiency in applying compliance and ethics standards in complex health care environments.
+ Commitment and ability to:
+ Work in a team-based environment,
+ Manage patient and highly reputable faculty and interactions/communication with extreme care, patience, confidentiality, and consideration, and
+ Maintain an environment with open channels of communication within the Institute with workforce members, patients, and others.
+ Possess excellent organization, attention to detail, technical and analytical skills. Can gather relevant information systematically, break down problems into essential components and can make sound decisions. Approach problems with curiosity and open-mindedness and offer new ideas, solutions and/or options. Demonstrate discretion, diplomacy, and good judgment.
+ Possess effective communication and presentation skills, clearly and concisely express ideas in groups and one-to-one conversations, formal and informal documents. Adapt strong writing and communications styles to fit the audience.
+ Self-starter, positive attitude, ability to work independently, enjoys learning and staying current with industry developments, regulations, and best practices.
+ Demonstrate knowledge in setting and achieving challenging goals.
+ Adaptability to a fast-paced environment
+ Ability to thrive in a dynamic work setting, balancing multiple responsibilities while maintaining effectiveness.
+ Strong interpersonal skills to foster a collaborative team environment.
**Pay Transparency Statement**
The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate's relevant experience, skills and qualifications.
For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA)
$163,100 - $186,700
At 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 to reduce the burden of cancer for all, we are committed to having faculty and staff that offer multifaceted experiences. 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 characteristics protected by law.
**EEOC Poster**
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0
Regulatory Compliance Advisor
Maryland, Maryland
Genesis Healthcare
Posted 4 days ago
Job Viewed
Job Description
Overview
The Regulatory Compliance Advisor is responsible for overseeing Regulatory
compliance and the Quality Review process that supports compliance to state and federal
regulations, as well as GHC policies and procedures. He/she will oversee the process to
ensure quality reviews will be conducted at each center a minimum of annually. This
role will collaborate with Market Advisors, Market Clinical Advisors, Center Leadership,
food and nutrition services, rehab services, property management, and others as needed,
to ensure their involvement in the process.
Responsibilities
1. Collaborate with Market teams to create an overall survey improvement plan as well as
individual center survey improvement plans to include focus on past survey history,
Quality Review results, leadership training needs and a roadmap for completion of CEP's
2. Establish priority centers based on Health Inspection ratings, SFF status, Government
oversight, Special licenses, or other special circumstances.
3. Participate in Quality Reviews in the Market. Ensure the Quality Review is scheduled no
less than 90 days prior to the survey window opening.
4. Provide support during all Health inspections on site or remotely during the survey,
ensure plan of correction is submitted timely and validate readiness for revisit.
5. Collaborate with Market Advisor, Clinical Advisor or other designated Market team
members to ensure coordination and appropriate selection of team members, sample
selection, and informing the Center of the date and items needed for the Quality Review.
6. Will ensure the approved Quality Review process will be followed accordingly and
Critical Element Pathways are utilized. Support Market team in assessing center staff's
ability to identify issues.
7. Oversee that coaching is part of Quality Review process for Center staff in survey
management to help them build confidence and be well prepared for the survey.
8. Ensures process in place for an informal exit review with the Center staff so center may
begin immediate correction of identified issues.
9. Ensure process is in place for Quality Review findings report is provided to the
Administrator within 10 days of the Quality Review Collaborate with others to identify
resources/processes needed to assure action plan has been completed prior to survey
a. Schedule validation visit.
10. Provide feedback to the National team to ensure the Quality Review process remains current with changing regulations.
11. Analyze effectiveness of Quality Review process by comparing Quality Review and
actual survey findings.
12. Maintain knowledge of state and federal long-term care regulations.
13. Be a resource for federal and state regulatory changes and inform Market team and
Center leaders of regulatory changes.
14. Ensure processes in place to evaluate Center staff ability to manage the survey process
and interact with surveyors.
15. Prepare and present training sessions for Market related to survey process, regulatory
guidelines and any other related issue identified in coordination with the Market/National
team.
16. Provide feedback regarding findings and need for changes to policies, programs, or
training.
17. Ensure survey information has been entered into the regulatory tracking system.
18. Works with Market and National team as appropriate to:
a. Respond to critical events
b. Support clinical and operations practice
c. Leadership and direction on key clinical projects;
19. Establish relationships with regional CMS staff and state survey agencies
20. Identify SFF Centers, SFF candidate centers, Low Health Inspection Star ratings and
implement Focus Center calls
21. Collaborates with the Market Team to understand and improve the quality outcomes for
residents, families and staff at designated centers.
22. Serve as resource expert on available resources including but not limited to Team TSI,
Compliance Store, AAPCN, Care Data Hub., QSEP
23. Meet with New NHA/DON's to review survey history and educate on Genesis tools and
resources related to Regulatory compliance.
24. Other duties as assigned.
Qualifications
1. R.N. or Bachelors in healthcare field preferred. Three to five years of experience
in the long-term care industry with preferred experience in regulatory compliance.
2. Must have an understanding of long-term care guidelines and regulations and be
knowledgeable in the state survey process.
3. Must be proficient in observation of both resident care and the Center
environment, and reviewing charts and other regulatory documentation requirements.
4. Must be experienced in interpreting the regulation and associated F-tags and
applying them to the findings.
5. Must be knowledgeable of the CMS enforcement process related to surveys, i.e.,
CMPs, DPNAs, etc.
6. Must be able to travel extensively.
#GHC25
Posted Salary Range
USD $150,000.00 - USD $160,000.00 /Yr.
Genesis HealthCare, Inc. and all affiliated entities (collectively "Genesis") has a strong commitment to diversity that is fully supported and practiced by our officers and leadership team. Genesis provides equal employment opportunities to all employees and applicants for employment without regard to actual or perceived race, color, religion, gender, gender expression, gender identity, sex, sexual orientation, HIV status, national origin, age, disability, marital status, pregnancy, ancestry, citizenship, genetic information, amnesty, military status or status as protected veterans, or any other legally protected characteristic. Genesis is an Affirmative Action and Equal Opportunity Employer and our goal is to foster an inclusive and accessible workplace free from discrimination and harassment where everyone has equal opportunities to succeed.
The Regulatory Compliance Advisor is responsible for overseeing Regulatory
compliance and the Quality Review process that supports compliance to state and federal
regulations, as well as GHC policies and procedures. He/she will oversee the process to
ensure quality reviews will be conducted at each center a minimum of annually. This
role will collaborate with Market Advisors, Market Clinical Advisors, Center Leadership,
food and nutrition services, rehab services, property management, and others as needed,
to ensure their involvement in the process.
Responsibilities
1. Collaborate with Market teams to create an overall survey improvement plan as well as
individual center survey improvement plans to include focus on past survey history,
Quality Review results, leadership training needs and a roadmap for completion of CEP's
2. Establish priority centers based on Health Inspection ratings, SFF status, Government
oversight, Special licenses, or other special circumstances.
3. Participate in Quality Reviews in the Market. Ensure the Quality Review is scheduled no
less than 90 days prior to the survey window opening.
4. Provide support during all Health inspections on site or remotely during the survey,
ensure plan of correction is submitted timely and validate readiness for revisit.
5. Collaborate with Market Advisor, Clinical Advisor or other designated Market team
members to ensure coordination and appropriate selection of team members, sample
selection, and informing the Center of the date and items needed for the Quality Review.
6. Will ensure the approved Quality Review process will be followed accordingly and
Critical Element Pathways are utilized. Support Market team in assessing center staff's
ability to identify issues.
7. Oversee that coaching is part of Quality Review process for Center staff in survey
management to help them build confidence and be well prepared for the survey.
8. Ensures process in place for an informal exit review with the Center staff so center may
begin immediate correction of identified issues.
9. Ensure process is in place for Quality Review findings report is provided to the
Administrator within 10 days of the Quality Review Collaborate with others to identify
resources/processes needed to assure action plan has been completed prior to survey
a. Schedule validation visit.
10. Provide feedback to the National team to ensure the Quality Review process remains current with changing regulations.
11. Analyze effectiveness of Quality Review process by comparing Quality Review and
actual survey findings.
12. Maintain knowledge of state and federal long-term care regulations.
13. Be a resource for federal and state regulatory changes and inform Market team and
Center leaders of regulatory changes.
14. Ensure processes in place to evaluate Center staff ability to manage the survey process
and interact with surveyors.
15. Prepare and present training sessions for Market related to survey process, regulatory
guidelines and any other related issue identified in coordination with the Market/National
team.
16. Provide feedback regarding findings and need for changes to policies, programs, or
training.
17. Ensure survey information has been entered into the regulatory tracking system.
18. Works with Market and National team as appropriate to:
a. Respond to critical events
b. Support clinical and operations practice
c. Leadership and direction on key clinical projects;
19. Establish relationships with regional CMS staff and state survey agencies
20. Identify SFF Centers, SFF candidate centers, Low Health Inspection Star ratings and
implement Focus Center calls
21. Collaborates with the Market Team to understand and improve the quality outcomes for
residents, families and staff at designated centers.
22. Serve as resource expert on available resources including but not limited to Team TSI,
Compliance Store, AAPCN, Care Data Hub., QSEP
23. Meet with New NHA/DON's to review survey history and educate on Genesis tools and
resources related to Regulatory compliance.
24. Other duties as assigned.
Qualifications
1. R.N. or Bachelors in healthcare field preferred. Three to five years of experience
in the long-term care industry with preferred experience in regulatory compliance.
2. Must have an understanding of long-term care guidelines and regulations and be
knowledgeable in the state survey process.
3. Must be proficient in observation of both resident care and the Center
environment, and reviewing charts and other regulatory documentation requirements.
4. Must be experienced in interpreting the regulation and associated F-tags and
applying them to the findings.
5. Must be knowledgeable of the CMS enforcement process related to surveys, i.e.,
CMPs, DPNAs, etc.
6. Must be able to travel extensively.
#GHC25
Posted Salary Range
USD $150,000.00 - USD $160,000.00 /Yr.
Genesis HealthCare, Inc. and all affiliated entities (collectively "Genesis") has a strong commitment to diversity that is fully supported and practiced by our officers and leadership team. Genesis provides equal employment opportunities to all employees and applicants for employment without regard to actual or perceived race, color, religion, gender, gender expression, gender identity, sex, sexual orientation, HIV status, national origin, age, disability, marital status, pregnancy, ancestry, citizenship, genetic information, amnesty, military status or status as protected veterans, or any other legally protected characteristic. Genesis is an Affirmative Action and Equal Opportunity Employer and our goal is to foster an inclusive and accessible workplace free from discrimination and harassment where everyone has equal opportunities to succeed.
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1
Regulatory Compliance Director
46202 Indianapolis, Indiana
Roche
Posted 4 days ago
Job Viewed
Job Description
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
**The Position**
**The Opportunity**
The Regulatory Compliance Director is a people leader role. Primary responsibilities include leading a team of high performing regulatory compliance professionals and managing FDA regulatory matters concerning advertising and promotional activities. The role requires broad expert knowledge and experience in analyzing and assessing FDA regulatory requirements in the context of business strategy and initiatives. The ideal candidate will collaborate with cross-functional teams, including marketing, medical affairs, legal, and other business stakeholders. The Regulatory Compliance Director may contribute to global cross-functional or cross-chapter squads, taking a leading role in navigating complex situations within the quality and regulatory compliance landscape to deliver solutions that enable the business to meet customer/patient needs and FDA regulatory requirements.
Primary Responsibilities:
+ Develop and implement regulatory strategies for advertising and promotional materials to ensure compliance with FDA regulations and other applicable guidelines.
+ Assess the impact of labeling language on promotional strategies to ensure compliance and alignment with commercial objectives.
+ Work collaboratively throughout the organization in a leadership, advisory, and facilitative capacity utilizing interdepartmental teams and systems to achieve compliance, quality improvement and risk management goals and objectives.
+ Develop an in-depth working knowledge of the products, pipeline, market and business model and apply this knowledge in managing direct reports and in the delivery of sound and practical counsel and advice focused on regulatory compliance.
+ Partner with Roche's sales, marketing, and other commercial teams, to develop and implement the effective sale, distribution, marketing and advertising of Roche's product portfolio in the U.S. by providing well-reasoned legal advice and practical and creative solutions to complex regulatory issues in support of business objectives.
+ Collaborate with, support and provide regulatory guidance and expertise to Roche business stakeholders in the assessment and implementation of third-party collaborations and partnering.
+ Collaborate with the RDC US Chief Compliance Officer to support Roche's compliance programs.
+ Support and enable company compliance with policies, procedures, and code of conduct.
+ Recruit, develop, support and manage a team of high performing regulatory compliance professionals and provide guidance and coaching in developing the team's skills and knowledge.
+ Sponsor and support various team projects and initiatives, including making continuous improvements to commercial processes and liaising with business partners to assist in creating or improving relevant policies.
+ Help set priorities for the Roche US Commercial Affiliate Legal & Compliance department and actively engage as an advisor and leader within the department and across the organization.
**Who You Are**
+ Education: Doctor of Jurisprudence from an ABA-accredited law school, licensed to practice law in one or more of the 50 states.
+ Professional experience: Preferably, at least 8-10 years' experience practicing law at a large- to medium-sized law firm or within a corporate law department; practice should include areas of specialization in FDA regulatory law, with a focus on advertising and promotion. Substantial industry experience also considered.
+ Strongly Preferred Skills/Expertise:
+ In-depth knowledge of FDA regulations and familiarity with FTC regulations related to advertising and promotion.
+ Demonstrated experience in medical device advertising and industry best practices with deep understanding of regulatory frameworks that affect medical device advertising and marketing.
+ Experience reviewing and providing compliance counsel on advertising, marketing, and/or promotion for prescription drugs, biologics, or medical devices.
+ Strong understanding of the regulatory landscape and the ability to provide strategic guidance to cross-functional teams.
+ Must have strong leadership skills to inspire, empower, and develop regulatory professionals with a desire to coach and develop the team.
+ Previous experience managing direct reports, stakeholders and/or cross-functional teams to successfully complete objectives/projects.
+ Excellent communication and interpersonal skills, with ability to effectively collaborate with internal and external stakeholders.
+ Willingness and ability to deliver a consistent message in the face of pressure or adversity.
+ Ability to encourage transparent and connected culture between the Legal and Compliance Department and business stakeholders.
This position is based in **Indianapolis, IN** and has an in office requirement of 3 days/wk.
The expected salary range for this position based on the primary location of Indiana is $188,200 - 349,400. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
**Benefits ( benefits are not available for this job posting.**
**Who we are**
A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let's build a healthier future, together.
Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants ( .
**The Position**
**The Opportunity**
The Regulatory Compliance Director is a people leader role. Primary responsibilities include leading a team of high performing regulatory compliance professionals and managing FDA regulatory matters concerning advertising and promotional activities. The role requires broad expert knowledge and experience in analyzing and assessing FDA regulatory requirements in the context of business strategy and initiatives. The ideal candidate will collaborate with cross-functional teams, including marketing, medical affairs, legal, and other business stakeholders. The Regulatory Compliance Director may contribute to global cross-functional or cross-chapter squads, taking a leading role in navigating complex situations within the quality and regulatory compliance landscape to deliver solutions that enable the business to meet customer/patient needs and FDA regulatory requirements.
Primary Responsibilities:
+ Develop and implement regulatory strategies for advertising and promotional materials to ensure compliance with FDA regulations and other applicable guidelines.
+ Assess the impact of labeling language on promotional strategies to ensure compliance and alignment with commercial objectives.
+ Work collaboratively throughout the organization in a leadership, advisory, and facilitative capacity utilizing interdepartmental teams and systems to achieve compliance, quality improvement and risk management goals and objectives.
+ Develop an in-depth working knowledge of the products, pipeline, market and business model and apply this knowledge in managing direct reports and in the delivery of sound and practical counsel and advice focused on regulatory compliance.
+ Partner with Roche's sales, marketing, and other commercial teams, to develop and implement the effective sale, distribution, marketing and advertising of Roche's product portfolio in the U.S. by providing well-reasoned legal advice and practical and creative solutions to complex regulatory issues in support of business objectives.
+ Collaborate with, support and provide regulatory guidance and expertise to Roche business stakeholders in the assessment and implementation of third-party collaborations and partnering.
+ Collaborate with the RDC US Chief Compliance Officer to support Roche's compliance programs.
+ Support and enable company compliance with policies, procedures, and code of conduct.
+ Recruit, develop, support and manage a team of high performing regulatory compliance professionals and provide guidance and coaching in developing the team's skills and knowledge.
+ Sponsor and support various team projects and initiatives, including making continuous improvements to commercial processes and liaising with business partners to assist in creating or improving relevant policies.
+ Help set priorities for the Roche US Commercial Affiliate Legal & Compliance department and actively engage as an advisor and leader within the department and across the organization.
**Who You Are**
+ Education: Doctor of Jurisprudence from an ABA-accredited law school, licensed to practice law in one or more of the 50 states.
+ Professional experience: Preferably, at least 8-10 years' experience practicing law at a large- to medium-sized law firm or within a corporate law department; practice should include areas of specialization in FDA regulatory law, with a focus on advertising and promotion. Substantial industry experience also considered.
+ Strongly Preferred Skills/Expertise:
+ In-depth knowledge of FDA regulations and familiarity with FTC regulations related to advertising and promotion.
+ Demonstrated experience in medical device advertising and industry best practices with deep understanding of regulatory frameworks that affect medical device advertising and marketing.
+ Experience reviewing and providing compliance counsel on advertising, marketing, and/or promotion for prescription drugs, biologics, or medical devices.
+ Strong understanding of the regulatory landscape and the ability to provide strategic guidance to cross-functional teams.
+ Must have strong leadership skills to inspire, empower, and develop regulatory professionals with a desire to coach and develop the team.
+ Previous experience managing direct reports, stakeholders and/or cross-functional teams to successfully complete objectives/projects.
+ Excellent communication and interpersonal skills, with ability to effectively collaborate with internal and external stakeholders.
+ Willingness and ability to deliver a consistent message in the face of pressure or adversity.
+ Ability to encourage transparent and connected culture between the Legal and Compliance Department and business stakeholders.
This position is based in **Indianapolis, IN** and has an in office requirement of 3 days/wk.
The expected salary range for this position based on the primary location of Indiana is $188,200 - 349,400. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
**Benefits ( benefits are not available for this job posting.**
**Who we are**
A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let's build a healthier future, together.
Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants ( .
View Now
2
Regulatory Compliance Engineer
60532 Lisle, Illinois
International
Posted 1 day ago
Job Viewed
Job Description
Position Overview
As International continues to innovate and push the boundaries of the automotive industry, we are leading the charge on next-generation product development driven by trends such as electrification, autonomy, and connectivity. At the heart of our growth is the dedication to delivering the highest quality vehicles that meet the needs of customers worldwide. We're looking for a talented, experienced, and passionate Regulatory Compliance Engineer to join our team and help us take our company to the next level.
The position will be responsible for assuring all International products maintain regulatory compliance with the EPA, CARB, and ECCC. Strong management and Government relations skills will be required as this position will be the front-line representative for International supporting compliance related issues. The Regulatory Compliance Manager supports a variety of reporting requirements such as the authoring of defect reports, remedial plans, field fix documents, and/or defect investigation reports, field information reports, etc. In addition, the position will help to develop and guide International's product development strategies for both current and future regulation.
Responsibilities
+ Manage and track GHG emissions strategy, compliance reporting, and status
+ Provide guidance to platform teams regarding future regulation and product compliance strategies
+ International interface with Government agencies with respect to compliance reporting, investigations, warranty, and other various regulatory issues
+ Responsible for the authoring and submission of defect and warrantee reporting process to EPA, CARB and ECCC
+ Reviewing Federal, California, and ECCC Code of Regulations and manufacturer advisories
+ Managing Engine and Vehicle exemption control process and reporting to agencies
+ Analyzing Engine and Vehicle assembly plant build records, and daily emission labelbuild error reports
+ Reviewing and approving product change control requests and notices for regulatory requirements
Minimum Requirements
+ Bachelor's degree in Engineering, Engineering Technology or Computer Science
+ At least 2 years of experience in product design/development and/or computer science experience
OR
+ Master's degree in Engineering, Engineering Technology or Computer Science
Additional Requirements
+ Qualified candidates, excluding current employees, must be legally authorized on an unrestricted basis (US Citizen, Legal Permanent Resident, Refugee or Asylee) to be employed in the United States. We do not anticipate providing employment related work sponsorship for this position (e.g., H-1B status)
Desired Skills
+ Strong Technical communication and presentation skills
+ Strong intrapersonal and listening skills
+ Background Gasoline/Diesel and EV powertrain product knowledge
+ EV and ZEV powertrain experience
+ USMCA
+ GHG, NOX Emissions Tracking
+ Experience working with management systems aligned to standards such as ISO 31000 (Risk Management), with a focus on risk mitigation, continuous improvement, and stakeholder engagement to promote a strong culture of compliance
Benefits and Compensation
We provide a competitive total rewards package which ensures job satisfaction both on and off the job. We offer market-based compensation, health benefits, 401(k) match, tuition assistance, EAP, legal insurance, an employee discount program, and more.
For this position, the expected salary range will be commensurate with the candidate's applicable skills, knowledge and experience.
You can learn more about our comprehensive benefits package at Overview
ABOUT TRATON
With its brands Scania, MAN, International, and Volkswagen Truck & Bus, TRATON SE is the parent and holding company of the TRATON GROUP and one of the world's leading commercial vehicle manufacturers. The Group's product portfolio comprises trucks, buses, and light-duty commercial vehicles. "Transforming Transportation Together. For a sustainable world.": this intention underlines the Company's ambition to have a lasting and sustainable impact on the commercial vehicle business and on the Group's commercial growth.
ABOUT INTERNATIONALFrom a one-man company built on the world-changing invention of the McCormick reaper in 1831, to the 15,000-person-strong company we are today, few companies can lay claim to a history like International. Based in Lisle, Illinois, International Motors, LLC* creates solutions that deliver greater uptime and productivity to our customers throughout the full operation of our commercial vehicles. We build International® trucks and engines and IC Bus® school and commercial buses that are as tough and as smart as the people who drive them. We also develop Fleetrite® aftermarket parts. In everything we do, our vision is to accelerate the impact of sustainable mobility to create the cleaner, safer world we all deserve. As of 2021, we joined Scania, MAN and Volkswagen Truck & Bus in TRATON GROUP, a global champion of the truck and transport services industry. To learn more, visit ( .
*International Motors, LLC is d/b/a International Motors USA in Illinois, Missouri, New Jersey, Ohio, Texas, and Utah.
EEO Statement
We are an Equal Opportunity Employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
If you are a qualified individual with a disability and require a reasonable accommodation to access the online application system or participate in the interview process due to your disability, please email to request assistance. Kindly specify Job Requisition Number / Job Title and Location in response. Otherwise, your request may not be considered.
As International continues to innovate and push the boundaries of the automotive industry, we are leading the charge on next-generation product development driven by trends such as electrification, autonomy, and connectivity. At the heart of our growth is the dedication to delivering the highest quality vehicles that meet the needs of customers worldwide. We're looking for a talented, experienced, and passionate Regulatory Compliance Engineer to join our team and help us take our company to the next level.
The position will be responsible for assuring all International products maintain regulatory compliance with the EPA, CARB, and ECCC. Strong management and Government relations skills will be required as this position will be the front-line representative for International supporting compliance related issues. The Regulatory Compliance Manager supports a variety of reporting requirements such as the authoring of defect reports, remedial plans, field fix documents, and/or defect investigation reports, field information reports, etc. In addition, the position will help to develop and guide International's product development strategies for both current and future regulation.
Responsibilities
+ Manage and track GHG emissions strategy, compliance reporting, and status
+ Provide guidance to platform teams regarding future regulation and product compliance strategies
+ International interface with Government agencies with respect to compliance reporting, investigations, warranty, and other various regulatory issues
+ Responsible for the authoring and submission of defect and warrantee reporting process to EPA, CARB and ECCC
+ Reviewing Federal, California, and ECCC Code of Regulations and manufacturer advisories
+ Managing Engine and Vehicle exemption control process and reporting to agencies
+ Analyzing Engine and Vehicle assembly plant build records, and daily emission labelbuild error reports
+ Reviewing and approving product change control requests and notices for regulatory requirements
Minimum Requirements
+ Bachelor's degree in Engineering, Engineering Technology or Computer Science
+ At least 2 years of experience in product design/development and/or computer science experience
OR
+ Master's degree in Engineering, Engineering Technology or Computer Science
Additional Requirements
+ Qualified candidates, excluding current employees, must be legally authorized on an unrestricted basis (US Citizen, Legal Permanent Resident, Refugee or Asylee) to be employed in the United States. We do not anticipate providing employment related work sponsorship for this position (e.g., H-1B status)
Desired Skills
+ Strong Technical communication and presentation skills
+ Strong intrapersonal and listening skills
+ Background Gasoline/Diesel and EV powertrain product knowledge
+ EV and ZEV powertrain experience
+ USMCA
+ GHG, NOX Emissions Tracking
+ Experience working with management systems aligned to standards such as ISO 31000 (Risk Management), with a focus on risk mitigation, continuous improvement, and stakeholder engagement to promote a strong culture of compliance
Benefits and Compensation
We provide a competitive total rewards package which ensures job satisfaction both on and off the job. We offer market-based compensation, health benefits, 401(k) match, tuition assistance, EAP, legal insurance, an employee discount program, and more.
For this position, the expected salary range will be commensurate with the candidate's applicable skills, knowledge and experience.
You can learn more about our comprehensive benefits package at Overview
ABOUT TRATON
With its brands Scania, MAN, International, and Volkswagen Truck & Bus, TRATON SE is the parent and holding company of the TRATON GROUP and one of the world's leading commercial vehicle manufacturers. The Group's product portfolio comprises trucks, buses, and light-duty commercial vehicles. "Transforming Transportation Together. For a sustainable world.": this intention underlines the Company's ambition to have a lasting and sustainable impact on the commercial vehicle business and on the Group's commercial growth.
ABOUT INTERNATIONALFrom a one-man company built on the world-changing invention of the McCormick reaper in 1831, to the 15,000-person-strong company we are today, few companies can lay claim to a history like International. Based in Lisle, Illinois, International Motors, LLC* creates solutions that deliver greater uptime and productivity to our customers throughout the full operation of our commercial vehicles. We build International® trucks and engines and IC Bus® school and commercial buses that are as tough and as smart as the people who drive them. We also develop Fleetrite® aftermarket parts. In everything we do, our vision is to accelerate the impact of sustainable mobility to create the cleaner, safer world we all deserve. As of 2021, we joined Scania, MAN and Volkswagen Truck & Bus in TRATON GROUP, a global champion of the truck and transport services industry. To learn more, visit ( .
*International Motors, LLC is d/b/a International Motors USA in Illinois, Missouri, New Jersey, Ohio, Texas, and Utah.
EEO Statement
We are an Equal Opportunity Employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
If you are a qualified individual with a disability and require a reasonable accommodation to access the online application system or participate in the interview process due to your disability, please email to request assistance. Kindly specify Job Requisition Number / Job Title and Location in response. Otherwise, your request may not be considered.
View Now
3
Regulatory Compliance Engineer
60532 Lisle, Illinois
International
Posted 3 days ago
Job Viewed
Job Description
Position Overview
As International continues to innovate and push the boundaries of the automotive industry, we are leading the charge on next-generation product development driven by trends such as electrification, autonomy, and connectivity. At the heart of our growth is the dedication to delivering the highest quality vehicles that meet the needs of customers worldwide. We're looking for a talented, and passionate Regulatory Compliance Engineer to join our team and help us take our company to the next level.
The position will be responsible for assuring all International products maintain regulatory compliance with the EPA, CARB, and ECCC. Strong management and Government relations skills will be required as this position will be the front-line representative for International supporting compliance related issues. The Regulatory Compliance Engineer supports a variety of reporting requirements such as the authoring of defect reports, remedial plans, field fix documents, and/or defect investigation reports, field information reports, etc. In addition, the position will help to develop and guide International's product development strategies for both current and future regulation.
Responsibilities
+ International interface with Government agencies with respect to compliance reporting, investigations, warranty, and other various regulatory issues
+ Responsible for the authoring and submission of defect and warrantee reporting process to EPA, CARB and ECCC
+ Reviewing Federal, California, and ECCC Code of Regulations and manufacturer advisories
+ Managing Engine and Vehicle exemption control process and reporting to agencies
+ Analyzing Engine and Vehicle assembly plant build records, and daily emission label build error reports
+ Reviewing and approving product change control requests and notices for regulatory requirements
Minimum Requirements
+ Bachelor's degree in Engineering, Engineering Technology or Computer Science
OR
+ Currently pursuing a Bachelor's degree in Engineering, Engineering Technology or Computer Science and will obtain degree prior to first day of employment
Additional Requirements
+ Qualified candidates, excluding current employees, must be legally authorized on an unrestricted basis (US Citizen, Legal Permanent Resident, Refugee or Asylee) to be employed in the United States. We do not anticipate providing employment related work sponsorship for this position (e.g., H-1B status)
Desired Skills
+ Strong Technical communication and presentation skills
+ Strong interpersonal and listening skills
+ Background Gasoline/Diesel and EV powertrain product knowledge
+ EV and ZEV powertrain experience or knowledge
+ USMCA
+ GHG, NOX Emissions Tracking
+ Knowledge with management systems aligned to standards such as ISO 31000 (Risk Management), with a focus on risk mitigation, continuous improvement, and stakeholder engagement to promote a strong culture of compliance
Benefits and Compensation
We provide a competitive total rewards package which ensures job satisfaction both on and off the job. We offer market-based compensation, health benefits, 401(k) match, tuition assistance, EAP, legal insurance, an employee discount program, and more.
For this position, the expected salary range will be commensurate with the candidate's applicable skills, knowledge and experience.
You can learn more about our comprehensive benefits package at Overview
ABOUT TRATON
With its brands Scania, MAN, International, and Volkswagen Truck & Bus, TRATON SE is the parent and holding company of the TRATON GROUP and one of the world's leading commercial vehicle manufacturers. The Group's product portfolio comprises trucks, buses, and light-duty commercial vehicles. "Transforming Transportation Together. For a sustainable world.": this intention underlines the Company's ambition to have a lasting and sustainable impact on the commercial vehicle business and on the Group's commercial growth.
ABOUT INTERNATIONALFrom a one-man company built on the world-changing invention of the McCormick reaper in 1831, to the 15,000-person-strong company we are today, few companies can lay claim to a history like International. Based in Lisle, Illinois, International Motors, LLC* creates solutions that deliver greater uptime and productivity to our customers throughout the full operation of our commercial vehicles. We build International® trucks and engines and IC Bus® school and commercial buses that are as tough and as smart as the people who drive them. We also develop Fleetrite® aftermarket parts. In everything we do, our vision is to accelerate the impact of sustainable mobility to create the cleaner, safer world we all deserve. As of 2021, we joined Scania, MAN and Volkswagen Truck & Bus in TRATON GROUP, a global champion of the truck and transport services industry. To learn more, visit ( .
*International Motors, LLC is d/b/a International Motors USA in Illinois, Missouri, New Jersey, Ohio, Texas, and Utah.
EEO Statement
We are an Equal Opportunity Employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
If you are a qualified individual with a disability and require a reasonable accommodation to access the online application system or participate in the interview process due to your disability, please email to request assistance. Kindly specify Job Requisition Number / Job Title and Location in response. Otherwise, your request may not be considered.
As International continues to innovate and push the boundaries of the automotive industry, we are leading the charge on next-generation product development driven by trends such as electrification, autonomy, and connectivity. At the heart of our growth is the dedication to delivering the highest quality vehicles that meet the needs of customers worldwide. We're looking for a talented, and passionate Regulatory Compliance Engineer to join our team and help us take our company to the next level.
The position will be responsible for assuring all International products maintain regulatory compliance with the EPA, CARB, and ECCC. Strong management and Government relations skills will be required as this position will be the front-line representative for International supporting compliance related issues. The Regulatory Compliance Engineer supports a variety of reporting requirements such as the authoring of defect reports, remedial plans, field fix documents, and/or defect investigation reports, field information reports, etc. In addition, the position will help to develop and guide International's product development strategies for both current and future regulation.
Responsibilities
+ International interface with Government agencies with respect to compliance reporting, investigations, warranty, and other various regulatory issues
+ Responsible for the authoring and submission of defect and warrantee reporting process to EPA, CARB and ECCC
+ Reviewing Federal, California, and ECCC Code of Regulations and manufacturer advisories
+ Managing Engine and Vehicle exemption control process and reporting to agencies
+ Analyzing Engine and Vehicle assembly plant build records, and daily emission label build error reports
+ Reviewing and approving product change control requests and notices for regulatory requirements
Minimum Requirements
+ Bachelor's degree in Engineering, Engineering Technology or Computer Science
OR
+ Currently pursuing a Bachelor's degree in Engineering, Engineering Technology or Computer Science and will obtain degree prior to first day of employment
Additional Requirements
+ Qualified candidates, excluding current employees, must be legally authorized on an unrestricted basis (US Citizen, Legal Permanent Resident, Refugee or Asylee) to be employed in the United States. We do not anticipate providing employment related work sponsorship for this position (e.g., H-1B status)
Desired Skills
+ Strong Technical communication and presentation skills
+ Strong interpersonal and listening skills
+ Background Gasoline/Diesel and EV powertrain product knowledge
+ EV and ZEV powertrain experience or knowledge
+ USMCA
+ GHG, NOX Emissions Tracking
+ Knowledge with management systems aligned to standards such as ISO 31000 (Risk Management), with a focus on risk mitigation, continuous improvement, and stakeholder engagement to promote a strong culture of compliance
Benefits and Compensation
We provide a competitive total rewards package which ensures job satisfaction both on and off the job. We offer market-based compensation, health benefits, 401(k) match, tuition assistance, EAP, legal insurance, an employee discount program, and more.
For this position, the expected salary range will be commensurate with the candidate's applicable skills, knowledge and experience.
You can learn more about our comprehensive benefits package at Overview
ABOUT TRATON
With its brands Scania, MAN, International, and Volkswagen Truck & Bus, TRATON SE is the parent and holding company of the TRATON GROUP and one of the world's leading commercial vehicle manufacturers. The Group's product portfolio comprises trucks, buses, and light-duty commercial vehicles. "Transforming Transportation Together. For a sustainable world.": this intention underlines the Company's ambition to have a lasting and sustainable impact on the commercial vehicle business and on the Group's commercial growth.
ABOUT INTERNATIONALFrom a one-man company built on the world-changing invention of the McCormick reaper in 1831, to the 15,000-person-strong company we are today, few companies can lay claim to a history like International. Based in Lisle, Illinois, International Motors, LLC* creates solutions that deliver greater uptime and productivity to our customers throughout the full operation of our commercial vehicles. We build International® trucks and engines and IC Bus® school and commercial buses that are as tough and as smart as the people who drive them. We also develop Fleetrite® aftermarket parts. In everything we do, our vision is to accelerate the impact of sustainable mobility to create the cleaner, safer world we all deserve. As of 2021, we joined Scania, MAN and Volkswagen Truck & Bus in TRATON GROUP, a global champion of the truck and transport services industry. To learn more, visit ( .
*International Motors, LLC is d/b/a International Motors USA in Illinois, Missouri, New Jersey, Ohio, Texas, and Utah.
EEO Statement
We are an Equal Opportunity Employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
If you are a qualified individual with a disability and require a reasonable accommodation to access the online application system or participate in the interview process due to your disability, please email to request assistance. Kindly specify Job Requisition Number / Job Title and Location in response. Otherwise, your request may not be considered.
View Now
4
Regulatory Compliance Engineer
60532 Lisle, Illinois
International
Posted 4 days ago
Job Viewed
Job Description
Position Overview
As International continues to innovate and push the boundaries of the automotive industry, we are leading the charge on next-generation product development driven by trends such as electrification, autonomy, and connectivity. At the heart of our growth is the dedication to delivering the highest quality vehicles that meet the needs of customers worldwide. We're looking for a talented, experienced, and passionate Regulatory Compliance Engineer to join our team and help us take our company to the next level.
The position will be responsible for assuring all International products maintain regulatory compliance with the EPA, CARB, and ECCC. Strong management and Government relations skills will be required as this position will be the front-line representative for International supporting compliance related issues. The Regulatory Compliance Manager supports a variety of reporting requirements such as the authoring of defect reports, remedial plans, field fix documents, and/or defect investigation reports, field information reports, etc. In addition, the position will help to develop and guide International's product development strategies for both current and future regulation.
Responsibilities
+ Manage and track GHG emissions strategy, compliance reporting, and status
+ Provide guidance to platform teams regarding future regulation and product compliance strategies
+ International interface with Government agencies with respect to compliance reporting, investigations, warranty, and other various regulatory issues
+ Responsible for the authoring and submission of defect and warrantee reporting process to EPA, CARB and ECCC
+ Reviewing Federal, California, and ECCC Code of Regulations and manufacturer advisories
+ Managing Engine and Vehicle exemption control process and reporting to agencies
+ Analyzing Engine and Vehicle assembly plant build records, and daily emission labelbuild error reports
+ Reviewing and approving product change control requests and notices for regulatory requirements
Minimum Requirements
+ Bachelor's degree in Engineering, Engineering Technology or Computer Science
+ At least 5 years of experience in product design/development and/or computer science experience
OR
+ Master's degree in Engineering, Engineering Technology or Computer Science
+ At least 3 years of experience in product design/development and/or computer science experience
OR
+ PhD in Engineering, Engineering Technology or Computer Science
Additional Requirements
+ Qualified candidates, excluding current employees, must be legally authorized on an unrestricted basis (US Citizen, Legal Permanent Resident, Refugee or Asylee) to be employed in the United States. We do not anticipate providing employment related work sponsorship for this position (e.g., H-1B status)
Desired Skills
+ Strong Technical communication and presentation skills
+ Strong intrapersonal and listening skills
+ Background Gasoline/Diesel and EV powertrain product knowledge
+ EV and ZEV powertrain experience
+ USMCA
+ GHG, NOX Emissions Tracking
+ Experience working with management systems aligned to standards such as ISO 31000 (Risk Management), with a focus on risk mitigation, continuous improvement, and stakeholder engagement to promote a strong culture of compliance
Benefits and Compensation
We provide a competitive total rewards package which ensures job satisfaction both on and off the job. We offer market-based compensation, health benefits, 401(k) match, tuition assistance, EAP, legal insurance, an employee discount program, and more.
For this position, the expected salary range will be commensurate with the candidate's applicable skills, knowledge and experience.
You can learn more about our comprehensive benefits package at Overview
ABOUT TRATON
With its brands Scania, MAN, International, and Volkswagen Truck & Bus, TRATON SE is the parent and holding company of the TRATON GROUP and one of the world's leading commercial vehicle manufacturers. The Group's product portfolio comprises trucks, buses, and light-duty commercial vehicles. "Transforming Transportation Together. For a sustainable world.": this intention underlines the Company's ambition to have a lasting and sustainable impact on the commercial vehicle business and on the Group's commercial growth.
ABOUT INTERNATIONALFrom a one-man company built on the world-changing invention of the McCormick reaper in 1831, to the 15,000-person-strong company we are today, few companies can lay claim to a history like International. Based in Lisle, Illinois, International Motors, LLC* creates solutions that deliver greater uptime and productivity to our customers throughout the full operation of our commercial vehicles. We build International® trucks and engines and IC Bus® school and commercial buses that are as tough and as smart as the people who drive them. We also develop Fleetrite® aftermarket parts. In everything we do, our vision is to accelerate the impact of sustainable mobility to create the cleaner, safer world we all deserve. As of 2021, we joined Scania, MAN and Volkswagen Truck & Bus in TRATON GROUP, a global champion of the truck and transport services industry. To learn more, visit ( .
*International Motors, LLC is d/b/a International Motors USA in Illinois, Missouri, New Jersey, Ohio, Texas, and Utah.
EEO Statement
We are an Equal Opportunity Employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
If you are a qualified individual with a disability and require a reasonable accommodation to access the online application system or participate in the interview process due to your disability, please email to request assistance. Kindly specify Job Requisition Number / Job Title and Location in response. Otherwise, your request may not be considered.
As International continues to innovate and push the boundaries of the automotive industry, we are leading the charge on next-generation product development driven by trends such as electrification, autonomy, and connectivity. At the heart of our growth is the dedication to delivering the highest quality vehicles that meet the needs of customers worldwide. We're looking for a talented, experienced, and passionate Regulatory Compliance Engineer to join our team and help us take our company to the next level.
The position will be responsible for assuring all International products maintain regulatory compliance with the EPA, CARB, and ECCC. Strong management and Government relations skills will be required as this position will be the front-line representative for International supporting compliance related issues. The Regulatory Compliance Manager supports a variety of reporting requirements such as the authoring of defect reports, remedial plans, field fix documents, and/or defect investigation reports, field information reports, etc. In addition, the position will help to develop and guide International's product development strategies for both current and future regulation.
Responsibilities
+ Manage and track GHG emissions strategy, compliance reporting, and status
+ Provide guidance to platform teams regarding future regulation and product compliance strategies
+ International interface with Government agencies with respect to compliance reporting, investigations, warranty, and other various regulatory issues
+ Responsible for the authoring and submission of defect and warrantee reporting process to EPA, CARB and ECCC
+ Reviewing Federal, California, and ECCC Code of Regulations and manufacturer advisories
+ Managing Engine and Vehicle exemption control process and reporting to agencies
+ Analyzing Engine and Vehicle assembly plant build records, and daily emission labelbuild error reports
+ Reviewing and approving product change control requests and notices for regulatory requirements
Minimum Requirements
+ Bachelor's degree in Engineering, Engineering Technology or Computer Science
+ At least 5 years of experience in product design/development and/or computer science experience
OR
+ Master's degree in Engineering, Engineering Technology or Computer Science
+ At least 3 years of experience in product design/development and/or computer science experience
OR
+ PhD in Engineering, Engineering Technology or Computer Science
Additional Requirements
+ Qualified candidates, excluding current employees, must be legally authorized on an unrestricted basis (US Citizen, Legal Permanent Resident, Refugee or Asylee) to be employed in the United States. We do not anticipate providing employment related work sponsorship for this position (e.g., H-1B status)
Desired Skills
+ Strong Technical communication and presentation skills
+ Strong intrapersonal and listening skills
+ Background Gasoline/Diesel and EV powertrain product knowledge
+ EV and ZEV powertrain experience
+ USMCA
+ GHG, NOX Emissions Tracking
+ Experience working with management systems aligned to standards such as ISO 31000 (Risk Management), with a focus on risk mitigation, continuous improvement, and stakeholder engagement to promote a strong culture of compliance
Benefits and Compensation
We provide a competitive total rewards package which ensures job satisfaction both on and off the job. We offer market-based compensation, health benefits, 401(k) match, tuition assistance, EAP, legal insurance, an employee discount program, and more.
For this position, the expected salary range will be commensurate with the candidate's applicable skills, knowledge and experience.
You can learn more about our comprehensive benefits package at Overview
ABOUT TRATON
With its brands Scania, MAN, International, and Volkswagen Truck & Bus, TRATON SE is the parent and holding company of the TRATON GROUP and one of the world's leading commercial vehicle manufacturers. The Group's product portfolio comprises trucks, buses, and light-duty commercial vehicles. "Transforming Transportation Together. For a sustainable world.": this intention underlines the Company's ambition to have a lasting and sustainable impact on the commercial vehicle business and on the Group's commercial growth.
ABOUT INTERNATIONALFrom a one-man company built on the world-changing invention of the McCormick reaper in 1831, to the 15,000-person-strong company we are today, few companies can lay claim to a history like International. Based in Lisle, Illinois, International Motors, LLC* creates solutions that deliver greater uptime and productivity to our customers throughout the full operation of our commercial vehicles. We build International® trucks and engines and IC Bus® school and commercial buses that are as tough and as smart as the people who drive them. We also develop Fleetrite® aftermarket parts. In everything we do, our vision is to accelerate the impact of sustainable mobility to create the cleaner, safer world we all deserve. As of 2021, we joined Scania, MAN and Volkswagen Truck & Bus in TRATON GROUP, a global champion of the truck and transport services industry. To learn more, visit ( .
*International Motors, LLC is d/b/a International Motors USA in Illinois, Missouri, New Jersey, Ohio, Texas, and Utah.
EEO Statement
We are an Equal Opportunity Employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
If you are a qualified individual with a disability and require a reasonable accommodation to access the online application system or participate in the interview process due to your disability, please email to request assistance. Kindly specify Job Requisition Number / Job Title and Location in response. Otherwise, your request may not be considered.
View Now
5
Regulatory Compliance Pharmacist
30309 Midtown Atlanta, Georgia
Emory Healthcare/Emory University
Posted 1 day ago
Job Viewed
Job Description
**Overview** **8a-4:30p / Full Time / 40 Hours** **Be inspired. Be rewarded. Belong. At Emory Healthcare.** At Emory Healthcare we fuel your professional journey with better benefits, valuable resources, ongoing mentorship and leadership programs for all types of jobs, and a supportive environment that enables you to reach new heights in your career and be what you want to be. We provide: + Comprehensive health benefits that start day one + Student Loan Repayment Assistance & Reimbursement Programs + Family-focused benefits + Wellness incentives + Ongoing mentorship and leadership programs + And more! **Description** Job Summary: We are seeking an experienced pharmacist to oversee our regulatory and compliance program as it relates to federal and state requirements (i.e. GA BOP, DEA, DSCSA, FDA), diversion prevention, controlled substance accountability, proper medication handling, accreditation survey readiness, adherence to USP standards, and patient safety initiatives. Primary duties and responsibilities: Operational Excellence: 1. Oversees and optimizes data analytics related to the identification and prevention of controlled substance mismanagement and drug diversion. 2. Coordinates timely investigations of suspected drug diversion in collaboration with the appropriate site leaders and the Drug Diversion Response Team. 3. Assists with education and coaching following a confirmed case of diversion and reports/ documentation is complete timely adhering to regulatory requirements. 4. Provides education, coaching and training as necessary following discrepancies and / or deviation from standard operating procedures. 5. Performs audits related to regulatory requirements including, but not limited to, manual and electronic USP and compliance related documentation. 6. Assists with investigating pharmacy medication safety events and participates in relevant multi-disciplinary meetings. 7. Evaluates and facilitates workflow modifications to prevent diversion and/or meet regulatory and accreditation requirements. 8. Serves as the primary backup to the controlled substance coordinator as needed and as applicable. 9. Participates in proactive review and audits of high-risk diversion practices and required clinical and operational documentation. 10. Reviews and presents key performance indicator data related to regulatory, compliance, and accreditation to local and system leadership. Collaboration and Communication: 1. Works collaboratively with both internal and system pharmacy, operational, and clinical leadership. 2. Maintains open and effective communication with all stakeholders, providing updates and insights into findings. 3. Attends and participates in system and key stakeholder meetings related to drug diversion, compliance, safety, security, and accreditation. 4. Provides education sessions for pharmacy, nursing, and/or provider teams as needed. 5. Identifies opportunities to improve patient safety, medication management, and accreditation best practices. 6. Promotes standardization and best practice implementation where appropriate. 7. Prepares financial/operational/clinical/quality analysis materials for process improvement. 8. Serves as the primary liaison between pharmacy operations, compliance, and leadership to ensure consistent adherence to accreditation and regulatory requirements. Regulatory and Compliance Program Development: 1. Completes and maintains documentation as it relates to investigational activities, compliance tasks, and third-party audits, as applicable. 2. Coordinates and/or participates in safety event response team meetings and ensures timely follow-up. 3. Tracks and assists with REMS program compliance and audits. 4. Audits receiving, ordering, and processing of controlled substances and other high-risk medications. 5. Ensures adherence to federal, state, and local regulations including licensing, certifications, training, and collaborative practice agreements as applicable 6. Assists leadership in inspection or survey preparation and readiness related to BOP, GDNA, DEA, TJC, URAC, ACHC, and any other regulatory agencies. 7. Supports adherence to USP standards including <659>, <795>, <797>, and <800> as applicable. 8. Leads outcomes reporting and benchmarking related to accreditation as applicable. 9. Supports controlled substance, regulatory, compliance, and accreditation policy, procedure, and best practice development and implementation. Travel: Less than 10% of the time may be required. Work Type: In person Minimum Qualifications: Education: Graduate of an accredited school of Pharmacy. Experience: 3 years of applicable experience Licensure: Current Georgia Pharmacist License Preferred Qualifications: Education: ASHP accredited residency Experience: Previous diversion oversight, accreditation, and/or safety experience PHYSICAL REQUIREMENTS (Medium Max 25lbs): up to 25 lbs., 0-33% of the work day (occasionally) Lifting 25 lbs. max; Carrying of objects up to 25 lbs.; Occasional to frequent standing & walking, Occasional sitting, Close eye work (computers, typing, reading, writing), Physical demands may vary depending on assigned work area and work tasks. ENVIRONMENTAL FACTORS: Factors affecting environmental conditions may vary depending on the assigned work area and tasks. Environmental exposures include but are not limited to: Blood-borne pathogen exposure, Bio-hazardous waste chemicals/gases/fumes/vapors, Communicable diseases, Electrical shock, Floor Surfaces, Hot/Cold Temperatures, Indoor/Outdoor conditions, Latex, Lighting, Patient care/handling injuries, Radiation, Shift work, Travel may be required. Use of personal protective equipment, including respirators, and environmental conditions may vary depending on assigned work area and work tasks. **Connect With Us!** Connect with us for general consideration! **Division** _Emory Univ Hosp-Midtown_ **Campus Location** _Atlanta, GA, 30308_ **Campus Location** _US-GA-Atlanta_ **Department** _EHM Specialty Pharmacy_ **Job Type** _Regular Full-Time_ **Job Number** _ _ **Job Category** _Pharmacy_ **Schedule** _8a-4:30p_ **Standard Hours** _40 Hours_ **Hourly Minimum** _USD $62.45/Hr._ **Hourly Midpoint** _USD $74.23/Hr._ Emory Healthcare is an Equal Employment Opportunity employer committed to providing equal opportunity in all of its employment practices and decisions. Emory Healthcare prohibits discrimination, harassment, and retaliation in employment based on race, color, religion, national origin, sex, sexual orientation, gender identity or expression, pregnancy, age (40 and over), disability, citizenship, genetic information, service in the uniformed services, veteran status or any other classification protected by applicable federal, state, or local law.
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6
Regulatory Compliance Pharmacist
30309 Midtown Atlanta, Georgia
Emory Healthcare/Emory University
Posted 1 day ago
Job Viewed
Job Description
**Overview** **8a-4:30p / Full Time / 40 Hours** **Be inspired. Be rewarded. Belong. At Emory Healthcare.** At Emory Healthcare we fuel your professional journey with better benefits, valuable resources, ongoing mentorship and leadership programs for all types of jobs, and a supportive environment that enables you to reach new heights in your career and be what you want to be. We provide: + Comprehensive health benefits that start day one + Student Loan Repayment Assistance & Reimbursement Programs + Family-focused benefits + Wellness incentives + Ongoing mentorship and leadership programs + And more! **Description** Job Summary: We are seeking an experienced pharmacist to oversee our regulatory and compliance program as it relates to federal and state requirements (i.e. GA BOP, DEA, DSCSA, FDA), diversion prevention, controlled substance accountability, proper medication handling, accreditation survey readiness, adherence to USP standards, and patient safety initiatives. Primary duties and responsibilities: Operational Excellence: 1. Oversees and optimizes data analytics related to the identification and prevention of controlled substance mismanagement and drug diversion. 2. Coordinates timely investigations of suspected drug diversion in collaboration with the appropriate site leaders and the Drug Diversion Response Team. 3. Assists with education and coaching following a confirmed case of diversion and reports/ documentation is complete timely adhering to regulatory requirements. 4. Provides education, coaching and training as necessary following discrepancies and / or deviation from standard operating procedures. 5. Performs audits related to regulatory requirements including, but not limited to, manual and electronic USP and compliance related documentation. 6. Assists with investigating pharmacy medication safety events and participates in relevant multi-disciplinary meetings. 7. Evaluates and facilitates workflow modifications to prevent diversion and/or meet regulatory and accreditation requirements. 8. Serves as the primary backup to the controlled substance coordinator as needed and as applicable. 9. Participates in proactive review and audits of high-risk diversion practices and required clinical and operational documentation. 10. Reviews and presents key performance indicator data related to regulatory, compliance, and accreditation to local and system leadership. Collaboration and Communication: 1. Works collaboratively with both internal and system pharmacy, operational, and clinical leadership. 2. Maintains open and effective communication with all stakeholders, providing updates and insights into findings. 3. Attends and participates in system and key stakeholder meetings related to drug diversion, compliance, safety, security, and accreditation. 4. Provides education sessions for pharmacy, nursing, and/or provider teams as needed. 5. Identifies opportunities to improve patient safety, medication management, and accreditation best practices. 6. Promotes standardization and best practice implementation where appropriate. 7. Prepares financial/operational/clinical/quality analysis materials for process improvement. 8. Serves as the primary liaison between pharmacy operations, compliance, and leadership to ensure consistent adherence to accreditation and regulatory requirements. Regulatory and Compliance Program Development: 1. Completes and maintains documentation as it relates to investigational activities, compliance tasks, and third-party audits, as applicable. 2. Coordinates and/or participates in safety event response team meetings and ensures timely follow-up. 3. Tracks and assists with REMS program compliance and audits. 4. Audits receiving, ordering, and processing of controlled substances and other high-risk medications. 5. Ensures adherence to federal, state, and local regulations including licensing, certifications, training, and collaborative practice agreements as applicable 6. Assists leadership in inspection or survey preparation and readiness related to BOP, GDNA, DEA, TJC, URAC, ACHC, and any other regulatory agencies. 7. Supports adherence to USP standards including <659>, <795>, <797>, and <800> as applicable. 8. Leads outcomes reporting and benchmarking related to accreditation as applicable. 9. Supports controlled substance, regulatory, compliance, and accreditation policy, procedure, and best practice development and implementation. Travel: Less than 10% of the time may be required. Work Type: In person Minimum Qualifications: Education: Graduate of an accredited school of Pharmacy. Experience: 3 years of applicable experience Licensure: Current Georgia Pharmacist License Preferred Qualifications: Education: ASHP accredited residency Experience: Previous diversion oversight, accreditation, and/or safety experience PHYSICAL REQUIREMENTS (Medium Max 25lbs): up to 25 lbs., 0-33% of the work day (occasionally) Lifting 25 lbs. max; Carrying of objects up to 25 lbs.; Occasional to frequent standing & walking, Occasional sitting, Close eye work (computers, typing, reading, writing), Physical demands may vary depending on assigned work area and work tasks. ENVIRONMENTAL FACTORS: Factors affecting environmental conditions may vary depending on the assigned work area and tasks. Environmental exposures include but are not limited to: Blood-borne pathogen exposure, Bio-hazardous waste chemicals/gases/fumes/vapors, Communicable diseases, Electrical shock, Floor Surfaces, Hot/Cold Temperatures, Indoor/Outdoor conditions, Latex, Lighting, Patient care/handling injuries, Radiation, Shift work, Travel may be required. Use of personal protective equipment, including respirators, and environmental conditions may vary depending on assigned work area and work tasks. **Connect With Us!** Connect with us for general consideration! **Division** _Emory Univ Hosp-Midtown_ **Campus Location** _Atlanta, GA, 30308_ **Campus Location** _US-GA-Atlanta_ **Department** _WEM Infusion Pharmacy_ **Job Type** _Regular Full-Time_ **Job Number** _ _ **Job Category** _Pharmacy_ **Schedule** _8a-4:30p_ **Standard Hours** _40 Hours_ **Hourly Minimum** _USD $62.45/Hr._ **Hourly Midpoint** _USD $74.23/Hr._ Emory Healthcare is an Equal Employment Opportunity employer committed to providing equal opportunity in all of its employment practices and decisions. Emory Healthcare prohibits discrimination, harassment, and retaliation in employment based on race, color, religion, national origin, sex, sexual orientation, gender identity or expression, pregnancy, age (40 and over), disability, citizenship, genetic information, service in the uniformed services, veteran status or any other classification protected by applicable federal, state, or local law.
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7
Regulatory Compliance Pharmacist
30309 Midtown Atlanta, Georgia
Emory Healthcare/Emory University
Posted 1 day ago
Job Viewed
Job Description
**Overview** **8a-4:30p / Full Time / 40 Hours** **Be inspired. Be rewarded. Belong. At Emory Healthcare.** At Emory Healthcare we fuel your professional journey with better benefits, valuable resources, ongoing mentorship and leadership programs for all types of jobs, and a supportive environment that enables you to reach new heights in your career and be what you want to be. We provide: + Comprehensive health benefits that start day one + Student Loan Repayment Assistance & Reimbursement Programs + Family-focused benefits + Wellness incentives + Ongoing mentorship and leadership programs + And more! **Description** Job Summary: We are seeking an experienced pharmacist to oversee our regulatory and compliance program as it relates to federal and state requirements (i.e. GA BOP, DEA, DSCSA, FDA), diversion prevention, controlled substance accountability, proper medication handling, accreditation survey readiness, adherence to USP standards, and patient safety initiatives. Primary duties and responsibilities: Operational Excellence: 1. Oversees and optimizes data analytics related to the identification and prevention of controlled substance mismanagement and drug diversion. 2. Coordinates timely investigations of suspected drug diversion in collaboration with the appropriate site leaders and the Drug Diversion Response Team. 3. Assists with education and coaching following a confirmed case of diversion and reports/ documentation is complete timely adhering to regulatory requirements. 4. Provides education, coaching and training as necessary following discrepancies and / or deviation from standard operating procedures. 5. Performs audits related to regulatory requirements including, but not limited to, manual and electronic USP and compliance related documentation. 6. Assists with investigating pharmacy medication safety events and participates in relevant multi-disciplinary meetings. 7. Evaluates and facilitates workflow modifications to prevent diversion and/or meet regulatory and accreditation requirements. 8. Serves as the primary backup to the controlled substance coordinator as needed and as applicable. 9. Participates in proactive review and audits of high-risk diversion practices and required clinical and operational documentation. 10. Reviews and presents key performance indicator data related to regulatory, compliance, and accreditation to local and system leadership. Collaboration and Communication: 1. Works collaboratively with both internal and system pharmacy, operational, and clinical leadership. 2. Maintains open and effective communication with all stakeholders, providing updates and insights into findings. 3. Attends and participates in system and key stakeholder meetings related to drug diversion, compliance, safety, security, and accreditation. 4. Provides education sessions for pharmacy, nursing, and/or provider teams as needed. 5. Identifies opportunities to improve patient safety, medication management, and accreditation best practices. 6. Promotes standardization and best practice implementation where appropriate. 7. Prepares financial/operational/clinical/quality analysis materials for process improvement. 8. Serves as the primary liaison between pharmacy operations, compliance, and leadership to ensure consistent adherence to accreditation and regulatory requirements. Regulatory and Compliance Program Development: 1. Completes and maintains documentation as it relates to investigational activities, compliance tasks, and third-party audits, as applicable. 2. Coordinates and/or participates in safety event response team meetings and ensures timely follow-up. 3. Tracks and assists with REMS program compliance and audits. 4. Audits receiving, ordering, and processing of controlled substances and other high-risk medications. 5. Ensures adherence to federal, state, and local regulations including licensing, certifications, training, and collaborative practice agreements as applicable 6. Assists leadership in inspection or survey preparation and readiness related to BOP, GDNA, DEA, TJC, URAC, ACHC, and any other regulatory agencies. 7. Supports adherence to USP standards including <659>, <795>, <797>, and <800> as applicable. 8. Leads outcomes reporting and benchmarking related to accreditation as applicable. 9. Supports controlled substance, regulatory, compliance, and accreditation policy, procedure, and best practice development and implementation. Travel: Less than 10% of the time may be required. Work Type: In person Minimum Qualifications: Education: Graduate of an accredited school of Pharmacy. Experience: 3 years of applicable experience Licensure: Current Georgia Pharmacist License Preferred Qualifications: Education: ASHP accredited residency Experience: Previous diversion oversight, accreditation, and/or safety experience PHYSICAL REQUIREMENTS (Medium Max 25lbs): up to 25 lbs., 0-33% of the work day (occasionally) Lifting 25 lbs. max; Carrying of objects up to 25 lbs.; Occasional to frequent standing & walking, Occasional sitting, Close eye work (computers, typing, reading, writing), Physical demands may vary depending on assigned work area and work tasks. ENVIRONMENTAL FACTORS: Factors affecting environmental conditions may vary depending on the assigned work area and tasks. Environmental exposures include but are not limited to: Blood-borne pathogen exposure, Bio-hazardous waste chemicals/gases/fumes/vapors, Communicable diseases, Electrical shock, Floor Surfaces, Hot/Cold Temperatures, Indoor/Outdoor conditions, Latex, Lighting, Patient care/handling injuries, Radiation, Shift work, Travel may be required. Use of personal protective equipment, including respirators, and environmental conditions may vary depending on assigned work area and work tasks. **Connect With Us!** Connect with us for general consideration! **Division** _Emory Univ Hosp-Midtown_ **Campus Location** _Atlanta, GA, 30308_ **Campus Location** _US-GA-Atlanta_ **Department** _WEM Pharmaceutical Services_ **Job Type** _Regular Full-Time_ **Job Number** _ _ **Job Category** _Pharmacy_ **Schedule** _8a-4:30p_ **Standard Hours** _40 Hours_ **Hourly Minimum** _USD $62.45/Hr._ **Hourly Midpoint** _USD $74.23/Hr._ Emory Healthcare is an Equal Employment Opportunity employer committed to providing equal opportunity in all of its employment practices and decisions. Emory Healthcare prohibits discrimination, harassment, and retaliation in employment based on race, color, religion, national origin, sex, sexual orientation, gender identity or expression, pregnancy, age (40 and over), disability, citizenship, genetic information, service in the uniformed services, veteran status or any other classification protected by applicable federal, state, or local law.
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8
Regulatory Compliance Pharmacist
30309 Midtown Atlanta, Georgia
Emory Healthcare/Emory University
Posted today
Job Viewed
Job Description
**Overview** **8a-4:30p / Full Time / 40 Hours** **At least 3 years of experience as an inpatient hospital pharmacist.** Experience in medication safety, compliance, drug diversion and/or regulatory. **Be inspired. Be rewarded. Belong. At Emory Healthcare.** At Emory Healthcare we fuel your professional journey with better benefits, valuable resources, ongoing mentorship and leadership programs for all types of jobs, and a supportive environment that enables you to reach new heights in your career and be what you want to be. We provide: + Comprehensive health benefits that start day one + Student Loan Repayment Assistance & Reimbursement Programs + Family-focused benefits + Wellness incentives + Ongoing mentorship and leadership programs + And more! **Description** Job Summary: We are seeking an experienced pharmacist to oversee our regulatory and compliance program as it relates to federal and state requirements (i.e. GA BOP, DEA, DSCSA, FDA), diversion prevention, controlled substance accountability, proper medication handling, accreditation survey readiness, adherence to USP standards, and patient safety initiatives. Primary duties and responsibilities: Operational Excellence: 1. Oversees and optimizes data analytics related to the identification and prevention of controlled substance mismanagement and drug diversion. 2. Coordinates timely investigations of suspected drug diversion in collaboration with the appropriate site leaders and the Drug Diversion Response Team. 3. Assists with education and coaching following a confirmed case of diversion and reports/ documentation is complete timely adhering to regulatory requirements. 4. Provides education, coaching and training as necessary following discrepancies and / or deviation from standard operating procedures. 5. Performs audits related to regulatory requirements including, but not limited to, manual and electronic USP and compliance related documentation. 6. Assists with investigating pharmacy medication safety events and participates in relevant multi-disciplinary meetings. 7. Evaluates and facilitates workflow modifications to prevent diversion and/or meet regulatory and accreditation requirements. 8. Serves as the primary backup to the controlled substance coordinator as needed and as applicable. 9. Participates in proactive review and audits of high-risk diversion practices and required clinical and operational documentation. 10. Reviews and presents key performance indicator data related to regulatory, compliance, and accreditation to local and system leadership. Collaboration and Communication: 1. Works collaboratively with both internal and system pharmacy, operational, and clinical leadership. 2. Maintains open and effective communication with all stakeholders, providing updates and insights into findings. 3. Attends and participates in system and key stakeholder meetings related to drug diversion, compliance, safety, security, and accreditation. 4. Provides education sessions for pharmacy, nursing, and/or provider teams as needed. 5. Identifies opportunities to improve patient safety, medication management, and accreditation best practices. 6. Promotes standardization and best practice implementation where appropriate. 7. Prepares financial/operational/clinical/quality analysis materials for process improvement. 8. Serves as the primary liaison between pharmacy operations, compliance, and leadership to ensure consistent adherence to accreditation and regulatory requirements. Regulatory and Compliance Program Development: 1. Completes and maintains documentation as it relates to investigational activities, compliance tasks, and third-party audits, as applicable. 2. Coordinates and/or participates in safety event response team meetings and ensures timely follow-up. 3. Tracks and assists with REMS program compliance and audits. 4. Audits receiving, ordering, and processing of controlled substances and other high-risk medications. 5. Ensures adherence to federal, state, and local regulations including licensing, certifications, training, and collaborative practice agreements as applicable 6. Assists leadership in inspection or survey preparation and readiness related to BOP, GDNA, DEA, TJC, URAC, ACHC, and any other regulatory agencies. 7. Supports adherence to USP standards including <659>, <795>, <797>, and <800> as applicable. 8. Leads outcomes reporting and benchmarking related to accreditation as applicable. 9. Supports controlled substance, regulatory, compliance, and accreditation policy, procedure, and best practice development and implementation. Travel: Less than 10% of the time may be required. Work Type: In person Minimum Qualifications: Education: Graduate of an accredited school of Pharmacy. Experience: 3 years of applicable experience Licensure: Current Georgia Pharmacist License Preferred Qualifications: Education: ASHP accredited residency Experience: Previous diversion oversight, accreditation, and/or safety experience PHYSICAL REQUIREMENTS (Medium Max 25lbs): up to 25 lbs., 0-33% of the work day (occasionally) Lifting 25 lbs. max; Carrying of objects up to 25 lbs.; Occasional to frequent standing & walking, Occasional sitting, Close eye work (computers, typing, reading, writing), Physical demands may vary depending on assigned work area and work tasks. ENVIRONMENTAL FACTORS: Factors affecting environmental conditions may vary depending on the assigned work area and tasks. Environmental exposures include but are not limited to: Blood-borne pathogen exposure, Bio-hazardous waste chemicals/gases/fumes/vapors, Communicable diseases, Electrical shock, Floor Surfaces, Hot/Cold Temperatures, Indoor/Outdoor conditions, Latex, Lighting, Patient care/handling injuries, Radiation, Shift work, Travel may be required. Use of personal protective equipment, including respirators, and environmental conditions may vary depending on assigned work area and work tasks. **Connect With Us!** Connect with us for general consideration! **Division** _Emory Univ Hospital_ **Campus Location** _Atlanta, GA, 30322_ **Campus Location** _US-GA-Atlanta_ **Department** _EUH Pharmaceutical Services_ **Job Type** _Regular Full-Time_ **Job Number** _ _ **Job Category** _Pharmacy_ **Schedule** _8a-4:30p_ **Standard Hours** _40 Hours_ **Hourly Minimum** _USD $62.45/Hr._ **Hourly Midpoint** _USD $74.23/Hr._ Emory Healthcare is an Equal Employment Opportunity employer committed to providing equal opportunity in all of its employment practices and decisions. Emory Healthcare prohibits discrimination, harassment, and retaliation in employment based on race, color, religion, national origin, sex, sexual orientation, gender identity or expression, pregnancy, age (40 and over), disability, citizenship, genetic information, service in the uniformed services, veteran status or any other classification protected by applicable federal, state, or local law.
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