PCF | Pharmaceutical Compliance Forum

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EMPLOYMENT OPPORTUNITIES

DIRECTOR, ETHICS & COMPLIANCE BUSINESS PARTNER - Veloxis Pharmaceuticals, Inc.- Cary, NC US / Hybrid
DIRECTOR FIELD COMPLIANCE AND INVESTIGATIONS - Lundbeck Pharmaceuticals- Deerfield, IL US
DIRECTOR, GOVERNANCE, RISK MANAGEMENT & COMPLIANCE OPERATIONAL AUDITOR - Otsuka America Pharmaceutical- Princeton, NJ US; Hybrid
STRATEGIC BUSINESS PARTNER, ETHICS AND BUSINESS INTEGRITY - Sanofi- Cambridge, MA US
STRATEGIC BUSINESS PARTNER, NORTH AMERICA AND GLOBAL SPECIALTY CARE - Sanofi- Cambridge, MA US
MANAGER, HEALTHCARE LAW AUDITING & MONITORING - Otsuka- Princeton and Rockville, MD US
PRIVACY MANAGER - SpringWorks Therapeutics- Raleigh-Durham, NC US/ Hybrid, Stamford, CT US/ Hybrid
ASSOCIATE DIRECTOR (AD), COMPLIANCE OPERATIONS ANIMAL HEALTH (AH) - Boehringer Ingelheim- Based in Duluth, GA US (Atlanta area)
SENIOR MANAGER, NORTH AMERICAN HEALTHCARE COMPLIANCE - Grifols- North Carolina US/ Hybrid
U.S. ETHICS & COMPLIANCE TRANSPARENCY OPERATIONS MANAGER- Takeda Pharmaceutical- Lexington, MA US/Hybrid Remote

DIRECTOR, ETHICS & COMPLIANCE BUSINESS PARTNER - Veloxis Pharmaceuticals, Inc.
Remote Type: Hybrid
Location: Cary, NC US
Full time
Job Requisition ID: R4491

SUMMARY:
The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Veloxis Pharmaceuticals is an Asahi-Kasei Group Company based in Cary, NC. Our purpose is to transform transplant medicine as the primary partner to the community of transplant healthcare providers and their patients; our focus is in developing new therapies and programs to help transplant healthcare providers and the patients they treat. Veloxis provides a dynamic and innovative place to work that encourages professional development and embraces diversity. We seek creative, intelligent, action-oriented, and passionate individuals who thrive in a collaborative team environment. If you are interested in being part of a patient-centric company, then we invite you to learn more about the employment opportunities available at Veloxis. Our success is tied to the contribution of every team member, which is why we provide a valuable and competitive compensation package that includes health and insurance benefits, training, and development opportunities, as well as performance-based bonus eligibility.

Job Description:
This position contributes to the Company's success through supporting the Ethics and Compliance program in partnership with key business functions as defined below. The position is responsible for driving proactive and collaborative partnerships through consultation on applicable laws, regulations and guidance.

Summary of Key Responsibilities

Provides compliance advisory services to Commercial (Sales, Marketing, Market Access) and Medical Affairs business units (“Business Units”) in alignment with laws, regulations, the Company's Code of Conduct, polices/procedures, and the Company's Ethics and Compliance program. This includes:

Anti-bribery/anti-corruption laws (e.g., Foreign Corrupt Practices Act (FCPA))
Federal Food, Drug and Cosmetic Act (FD&C) and FDA regulations
False Claims Act (FCA), Anti-Kickback Statute (AKS)
Federal Sunshine Act and relevant state transparency/aggregate spend laws
PhRMA Code on Interactions with Health Care Professionals (HCP) guidance
OIG guidance relating to compliance programs and interactions with HCPs, and
Other relevant federal and state laws governing compliance.

Supports pull-through of Company's evolving global compliance program in accordance with the OIG 7 Elements of an Effective Compliance Program.
Identifies new and emerging risks within the Business Units' business functions and responds with a risk posture calibrated to business needs and growth imperatives.
Delivers meaningful and effective risk-based compliance training to the Business Units teams in alignment with department Compliance Plan.
Supports and pulls through the Ethics and Compliance Monitoring Program (“Monitoring Program”)), including conducting field-based employee visits (Commercial and Medical Affairs), attending live and virtual speaker programs, and other field-based interactions with HCPs as identified by the approved Monitoring Program.
Supports best practices to evolve the compliance program goals, objectives, strategy, and structure inclusive of assisting in establishing metrics and monitoring processes to demonstrate effectiveness over an expanded mandate.
Supports Compliance Operations in conducting investigations and corrective/preventative measures.
Supports the Company's Ethics and Compliance Committee on a regular basis in collaboration with the Company's Chief Ethics & Compliance Officer and the Ethics and Compliance team.
Supports the Company's' privacy program across the Business Units' business functions in partnership with the Company's Legal department.
Supports periodic internal reviews, risk assessments, monitoring, and auditing in partnership with business functions to ensure that Ethics and Compliance identifies potential compliance risks and remediates where necessary.
Participates in the periodic review and update of Compliance program policies and procedures.

Required Qualifications and Skills

BA/BS. MA/MS a plus.
Minimum of 4 years of relevant compliance experience in pharmaceuticals/biotech, preferably 6 years of compliance experience in a healthcare setting.
Experience in compliance program strategy and transformational initiatives between business units and corporate risk and compliance functions, preferred.
Ability to recognize compliance risk and develop workable strategies to mitigate such risk.
In-depth knowledge of U.S. laws, regulations, and codes relevant to job responsibilities.
Ability to collaborate with business partners, influence peers, and interact with both senior management and field-based team members.
Ability to build and maintain solid, collaborative working relationships across multiple functions and levels of management; and drive improvement initiatives with a sense of urgency.
Ability to work in a fast-paced, dynamic organization, supporting a rapidly growing business.
Exceptional relationship-building skills; must be a team player and support the Ethics and Compliance function's goal of proactive and collaborate relationships with all business functions.
Strong presentation, verbal, and written skills.
Strong computer skills, with literacy in new media, and experience integrating information and data from multiple applications. Advanced proficiency in MS Office Suite and any presentation tools.

Travel Requirements: Approximately 25-30% (national)

#LI-AS1 #Hybrid
As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.

Apply here
Posted 1/14/2025

DIRECTOR FIELD COMPLIANCE AND INVESTIGATIONS - Lundbeck Pharmaceuticals
Location: Deerfield, IL US

SUMMARY:
The Director, Field Compliance and Investigations will have direct responsibility for and assist with driving and implementing all elements of the Lundbeck Compliance Program, which are modeled after the seven elements of an effective compliance program. This role will focus on: (1) dedicated, strategic partnership with the business unit field-based teams, including sales and medical science liaisons; and (2) lead, manage and be responsible for all internal compliance investigations. This role will develop and implement Lundbeck's field compliance risk mitigation strategy, work with commercial and medical leadership to continually identify and mitigate compliance risks and work closely with key stakeholders and partner with lines of business (LOB) in support of field-based compliance and overall business objectives across the entire Business unit brand portfolio.

Essential Functions:

People Management: Manage matrix relationships with stakeholders across the entire organization to provide compliance guidance and drive an ethical and compliant culture in support of business objectives. Provide direction and feedback to other members of the Compliance team in relation to field compliance.
Investigations: Effectively lead, oversee and manage all internal investigations, while ensuring legal compliance and managing risk. Conduct internal investigations and manage disclosure log relating to alleged compliance violations. Partner with the CCO and Human Resources (HR) to recommend follow-up and appropriate corrective action. Perform quarterly audit and gap and trend analysis to develop risk mitigation strategies.
Field Compliance Oversight: Identify and lead strategic projects designed to ensure field compliance with policies and procedures. Responsible for strategy, trend and gap analysis, programs, policies, monitoring, training and corrective actions in support of promotional and MSL compliance for the field.
Field Risk Mitigation & Strategy: Develop and implement field compliance risk mitigation strategy including ongoing risk assessments, gap and risk analysis and results-oriented risk mitigation plans in support of field compliance and to determine effectiveness of Compliance trainings, education and other initiatives.
Dedicated Business Partnership: Develop and maintain trusted partnerships and effective lines of communication across the business unit commercial and medical organizations. Serve as a dedicated business partner to the field, including senior leadership. Proactively provide guidance and support to all business unit commercial and medical stakeholders across the organization on compliance matters. Participate in cross-functional initiatives and meetings.
Policies, Procedures and Controls, including Code of Conduct: Responsible for ongoing maintenance and updates to steering documents, policies and procedures. Partner with LOB to assist with reviews, development and updating of directives, policies and procedures.
Training, Education and Communications: Implement the compliance training program in accordance with company directives, policies and procedures. Partner with global compliance, LOB and the commercial and medical organizations to develop, maintain, and ensure appropriate training content, training matrices and training calendars. Deliver appropriate training content and coaching to ensure standards are clearly communicated to employees. Provide support for compliance communications program.
Monitoring and Auditing: Develop and oversee field-based auditing and monitoring plans to ensure compliance with Lundbeck's policies and procedures. Conduct field monitoring, data reviews and audits of key compliance risk areas, in accordance with the US monitoring program. Work with other departments to perform additional auditing related to healthcare compliance. Monitor field-based communications (commercial and medical), sponsorships, HCP exhibits, ad boards, conferences, HCP engagements, and FMV analysis and conduct related investigations. Draft reports and identify appropriate follow-up and risk mitigation initiatives. Assist with all auditing and monitoring programs and processes to ensure effectiveness of overall compliance program. Develop data dashboards in support of predictive analytics and risk management initiatives. Prepare and present monitoring and auditing results to Compliance Committee on periodic basis.
System Ownership: Serve as system owner for compliance program management software.
Third Party Management: Oversee vendors and third-party RFP processes. This includes reviewing vendor effectiveness, managing vendor relationships and performance reviews, identifying and evaluating new vendors as needed, managing budget, reviewing and verifying contract terms with Legal, reviewing invoices, and processing timely payment.
Advice, Guidance and Other Duties: Drive a compliant culture. Stay abreast of relevant laws and regulations and perform industry benchmarking as to Compliance oversight program. Proactively provide day-to-day guidance to business unit commercial and medical field-based teams on compliance matters. Implement and execute all obligations in support of government investigations and agreements, as assigned by CCO. Provide support to US compliance team and global compliance, as needed. Assist the CCO with the preparation of reports, summaries and documentation for internal and/or external use. Execute other duties as assigned by the CCO.

Required Education, Experience, and Skills:

Accredited bachelor's degree.
10+ years of Compliance-related experience in the pharmaceutical, biotech or medical device industry.
Demonstrated knowledge and understanding of FDA rules and regulations and Fraud and Abuse Laws, such as the Anti-Kickback Statute and the False Claims Act.
Strategic mindset and results-oriented problem-solving skills.
Ability to communicate effectively and professionally with individuals at all levels, internally and externally.
Demonstrated experience managing projects and working with multi-functional teams.
Experience in development of training and curriculum design, including delivery and implementation of training and workshops.
Proven skillset as a strong collaborator, problem solver and business partner.
Proactive, self-starter with a strong sense of ownership and accountability.
Demonstrated ability to work effectively in individual and team settings.
Strong planning, analytical, organizational, and time management skills.
Strong attention to detail.
Ability to function in a fast-paced environment handling multiple tasks simultaneously.
Demonstrated proficiency with AI tools and Microsoft Office suite, including Excel, Word, and PowerPoint; Internet, or other systems tracking software.
Experience administering live web meetings and training sessions with Zoom, Microsoft Teams, WebEX, GoToMeeting/GoToWebinar, Lync, or other webinar software.

Preferred Education, Experience, and Skills:

10+ years Compliance-related experience in the pharmaceutical industry.
Hands on experience supporting a learning management system and/or compliance program management software.
Experience building and performing analysis using data dashboards.
Experience drafting and updating policies and SOPs.
Product, marketing, or sales management experience.

Travel:

Willingness/Ability to travel up to 20% domestically. International travel may be required.

Apply here
Posted 1/11/2025

DIRECTOR, GOVERNANCE, RISK MANAGEMENT & COMPLIANCE OPERATIONAL AUDITOR - Otsuka America Pharmaceutical
Full Time
Location: Princeton, NJ US; Hybrid

Job Summary
Following the implementation of the Governance, Risk Management, and Compliance (GRC) program and Enterprise Risk Management (ERM) Assessment in the U.S., this new role is being created to continue to develop the U.S. Ethics & Compliance (E&C) operational audit program strategy and optimize our U.S. compliance risk assessments.

The Director, Governance, Risk Management & Compliance Operational Auditor will oversee and lead the development and execution of the operational audit strategy and report on operational audits of compliance and enterprise risks for Otsuka America Pharmaceutical, Inc. (OAPI) and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), collectively Otsuka. Additionally, this role will oversee and optimize the U.S. compliance risk assessment processes. This is a key role to continue to support U.S. E&C's GRC function and the Vice President & U.S. Chief Compliance Officer in executing an effective compliance program.

Job Description
The Director, Governance, Risk Management & Compliance Operational Auditor will be responsible to:

Develop, implement, and oversee the Otsuka operational audit strategy and program that assess the design and effectiveness of internal controls and identifies potential control gaps that may require remediation for Otsuka's enterprise and compliance risks.
Develop and maintain the annual audit plan (and audit universe) through engagement with senior leaders in U.S. E&C and other key Otsuka business stakeholders to ensure it is focused on the highest-risk activities and remains fit-for-purpose.
Oversee and lead operational audits of Otsuka's compliance and enterprise risks, by assessing the design and operating effectiveness of internal controls (through detailed transaction testing) to identify control gaps or risks.
Oversee, develop, and execute audit process steps, including reviewing audit documentation, designing audit testing procedures, interviewing stakeholders, reviewing and testing controls, and reviewing and documenting testing procedures and observations.
Validate audit findings and observations with management and communicate final audit results to senior management, through presentations and written reports that address observations, risks, root cause analyses, and recommendations.
Draft formal written audit reports or other Compliance reports that are clear, concise, and drive meaningful action to strengthen controls and mitigate compliance and enterprise risks.
Directly manage at least one full time employee (FTE), which includes providing oversight, coaching, ensuring completion of training, and creating and managing team goals.
Directly manage third party consultants and actively oversee audits and risk assessments conducted by third parties on Otsuka's behalf, ensuring audit quality and on-time delivery within budget.
Manage auditing and risk assessment budget, ensuring alignment with financial goals by tracking expenses and identifying cost-saving opportunities.
Collaborate cross-functionally with other U.S. E&C teams, including Aggregate Spend, Investigations, and Compliance Counsel and internal stakeholders on compliance matters. Establish and maintain effective relationships with internal stakeholders.
Draft sections of reports and documents intended for submission to various organizational committees, including the Vice President & U.S. Chief Compliance Officer, OAPI/OPDC Joint Boards of Directors, and Audit Committee.
Lead and oversee the U.S. Compliance Risk Assessment on an annual basis, working directly with senior management. Develop and recommend risk mitigation and strategies based on risk assessment outcomes. Ensure the risk assessment process and focus areas are continuously improved to reflect best practices, regulatory trends, and guidelines.
Support Executive Director, Governance, Risk Management & Compliance and Senior Director, Healthcare Law Auditing & Monitoring with other assignments, as needed. May include domestic travel up to 25%.
Maintain a working knowledge of relevant trends, laws and regulations pertaining to healthcare law, regulatory compliance, and auditing. Assists in developing or improving processes and procedures that promote compliance with healthcare laws, regulations, and guidance.

Qualifications
Required

At least 10 - 12 years of experience within the pharmaceutical industry performing auditing or monitoring activities and strong understanding of enterprise risk management frameworks, internal controls, and risk assessment and audit methodologies.
Pharmaceutical, Healthcare, or related industry experience.
Experience with regulators, external auditors, and independent review organizations.
Bachelor's degree in Accounting, Risk Management, or a related field.
Certified Public Accountant (CPA), Certified Internal Auditor (CIA), Certified Information Systems Auditor (CISA) or other certification or professional designation in accounting, compliance, or auditing.

Preferred

Experience at top tier accounting firm is preferred.

Competencies

Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

Disclaimer:
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request.

Statement Regarding Job Recruiting Fraud Scams
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.

Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.

To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External. Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: 800-363-5670. If you believe you are the victim of fraud resultingfrom a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities.

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Apply here
Posted 1/3/2025

STRATEGIC BUSINESS PARTNER, ETHICS AND BUSINESS INTEGRITY - Sanofi
Location: Cambridge, MA US
Time Type: Full time
End Date: March 3, 2025 (30+ days left to apply)
Job Requisition ID: R2773524

About the Job
Ready to push the limits of what's possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world.

This key position in Sanofi's Ethics & Business Integrity (E&BI) group serves as a Strategic Business Partner and Compliance Officer for Sanofi's North America and Global Specialty Care business. Serving as a driver of Sanofi's positive compliance culture, this position works closely with Commercial, Medical and enabling functions on various initiatives and projects and provides day-to-day advice and support on local and global E&BI matters. This position serves as colleagues' point of contact on compliance-related issues and concerns within their area of responsibility, which may include business units/areas such as Oncology, Neurology, Rare Diseases, Immunology, Research & Development and Patient Support Services. This position works collaboratively with other E&BI colleagues and members of Legal, People and Culture, Field Operations, Transparency, Finance and other functional and business areas and outside resources to support appropriate controls and risk mitigation. This position partners with their peer Strategic Business Partners to support robust governance, thoughtful risk taking and ethical practices across the company. This position routinely leads reporting to senior management at both business and E&BI-led meetings. Finally, this position exercises independent judgment in assessing compliance-related matters and supporting the business, develops and advises on any needed compliance remediation strategies, provides strategic oversight of all elements of the Company's compliance program and reports to the Global and North America Head Strategic Advisor for Specialty Care.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

Provides strategic, timely and practical compliance advice and risk assessment on initiatives, projects and field and home office activities to individuals at all levels and roles in Sanofi's organization.
Partners with colleagues in North America and Global E&BI as well as other functional and business areas to implement local and global requirements, internal standards such as Sanofi's Code of Conduct, industry standards and the requirements of the company's Corporate Integrity Agreement (CIA).
Develops and delivers training on global and local healthcare requirements, guidance and updates from relevant government regulators and pertinent industry and internal standards.
Effectively communicates with Sanofi management on key risks and topics identified from Helpline inquiries, monitoring program results and daily oversight of the compliance program.
Maintains trusted relationships with leadership in Commercial, Medical and enabling functions to integrate compliance into strategic decisions.
Co-leads the necessary reporting in their areas of responsibility at meetings, including Compliance Committees, Business Updates and Town Halls.
Leads and participates in special projects, acting as a catalyst for corporate initiatives in the NA/Global E&BI Organization, such as business process improvement efforts.
Maintains strict confidentiality and discretion

About You
Required Educational Background and Job-Related Experience

Experience assessing fraud and abuse risk and problem solving in a risk-based, pragmatic way
Demonstrated ability to manage and lead change in a large, matrixed organization
Exceptional communication and relationship-management skills to enable partnership with key leaders in Commercial, Medical and enabling functions
Five years of proven experience in a strategic role in the pharmaceutical/life sciences industry preferred
B.A./B.S. degree required; advanced degree in a related field preferred
Excellent written, oral and presentation skills

Why Choose Us?

Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

Apply here
Posted 12/21/2024

STRATEGIC BUSINESS PARTNER, NORTH AMERICA AND GLOBAL SPECIALTY CARE - Sanofi
Location: Cambridge, MA US

Main Responsibilities:

Provides strategic, timely and practical compliance advice and risk assessment on initiatives, projects and field and home office activities to individuals at all levels and roles in Sanofi's organization.
Partners with colleagues in North America and Global E&BI as well as other functional and business areas to implement local and global requirements, internal standards such as Sanofi's Code of Conduct, industry standards and the requirements of the company's Corporate Integrity Agreement (CIA).
Develops and delivers training on global and local healthcare requirements, guidance and updates from relevant government regulators and pertinent industry and internal standards.
Effectively communicates with Sanofi management on key risks and topics identified from Helpline inquiries, monitoring program results and daily oversight of the compliance program.
Maintains trusted relationships with leadership in Commercial, Medical and enabling functions to integrate compliance into strategic decisions.
Co-leads the necessary reporting in their areas of responsibility at meetings, including Compliance Committees, Business Updates and Town Halls.
Leads and participates in special projects, acting as a catalyst for corporate initiatives in the NA/Global E&BI Organization, such as business process improvement efforts.
Maintains strict confidentiality and discretion

About You
Required Educational Background and Job-Related Experience

Experience assessing fraud and abuse risk and problem solving in a risk-based, pragmatic way
Demonstrated ability to manage and lead change in a large, matrixed organization
Exceptional communication and relationship-management skills to enable partnership with key leaders in Commercial, Medical and enabling functions
Five years of proven experience in a strategic role in the pharmaceutical/life sciences industry preferred
B.A./B.S. degree required; advanced degree in a related field preferred
Excellent written, oral and presentation skills

Why Choose Us?

Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.

Apply here
Posted 12/21/2024

MANAGER, HEALTHCARE LAW AUDITING & MONITORING - Otsuka
Locations: Princeton and Rockville, MD US
Time type: Full time
Posted: 30+ Days Ago
Job requisition id: R7961

Job Summary This position assists U.S. E&C's Governance, Risk Management, and Compliance (GRC) function supporting the Chief Compliance Officer in executing an effective compliance program. The Manager, Healthcare Law Auditing & Monitoring, executes the annual plan by conducting quarterly transactional analyses and live monitoring and may perform operational audits, and complete other auditing and monitoring assessments of promotional and non-promotional activities.

Job Description

Lead quarterly transactional analyses of data related, but not limited to emails, expenses, call notes, speaker programs, and HCP spend to help to ensure compliance with healthcare laws, regulations and guidance (such as the Anti-Kickback Statute, False Claims Act, OIG Guidance for Pharmaceutical Manufacturers, PhRMA Code, FDCA and PDMA)
Execute audits of processes and/or functions related to promotional and non-promotional activities, including, but not limited to, promotional materials, prescription drug samples, clinical trials, publications, and pricing agreements. Perform steps in the audit process including interviewing stakeholders, testing controls, communicating findings to stakeholders, drafting reports, and tracking corrective actions.
Assist with conducting the annual U.S. Compliance Risk Assessment, including conducting interviews and drafting reports.
Analyze and monitor compliance data and metrics to identify trends and assess the effectiveness and efficiency of monitoring activities and implement corrective actions, as needed. Contribute to continuous improvement of the U.S. E&C Compliance analytics platform.
Prepare reports that summarize areas of non-compliance and risks identified through HLAM monitoring activities.
Lead other ad-hoc reviews, inquiries, and investigations as required.
Collaborate cross-functionally with other U.S. E&C teams, including Aggregate Spend, Investigations, and Compliance Counsel.
Perform live monitoring (as needed) with domestic travel up to 25%.
Establish and maintain effective relationships with GRC, Legal Affairs, and other internal stakeholders and collaborate with them on compliance matters.
Possess and maintain an up-to-date knowledge and understanding of federal and state laws and regulations, industry codes of conduct and developments, and best practices applicable to the company's policies, practices or operations, including but not limited to the Sunshine Act, the OIG Compliance Program Guidance for Pharmaceutical Manufacturers, PhRMA Code on Interactions with Healthcare Providers, PDMA, AMA, and industry guidance documents, regulations regarding the promotion of marketed products, clinical trial regulations, and the False Claims Act and anti-kickback statutes.
Support Associate Director, Healthcare Law Auditing & Monitoring with other assignments as needed.

Qualifications/ Required
Knowledge/ Experience and Skills:

Lead by proactively taking ownership of tasks and projects and effectively communicating results to internal partners on compliance matters.
Strong organizational skills and the ability to effectively execute responsibilities independently with minimal oversight.
Able to work independently as an individual contributor and in a team setting.
Experience with data analysis, including ability to work with large amounts of data and organize results in a meaningful way to identify trends and potential red flags.
Strong verbal and written communications skills to communicate effectively with individuals up, down, and across the organization.
Strong interpersonal and project management skills.
Analytical thinker with strong conceptual and problem-solving skills.
Quick learner with the ability to analyze and identify new and emerging risks.
Bachelor's degree in a related field.
6+ years monitoring or auditing experience.in the pharma, healthcare of life science industry.
Understanding of healthcare laws and regulations and sales and marketing activities
CIA, CPA, or other certification in accounting, compliance, or auditing

Equal Opportunity Employer
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

Competencies

Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative. Come discover more about Otsuka and our benefit offerings.

Disclaimer:
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

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Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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Posted 12/18/2024

PRIVACY MANAGER - SpringWorks Therapeutics
Location: Raleigh-Durham, NC US/ Hybrid, Stamford, CT US/ Hybrid

About SpringWorks Therapeutics:
SpringWorks is a commercial-stage biopharmaceutical company applying a precision medicine approach to developing and delivering life-changing medicines for people with severe rare diseases and cancer.

SpringWorks has a diversified targeted oncology pipeline spanning solid tumors and hematological cancers, including clinical trials in rare tumor types and highly prevalent, genetically defined cancers. SpringWorks' strategic approach and operational excellence in clinical development have enabled it to rapidly advance its lead product candidates into late-stage trials and enter into multiple collaborations with innovators in industry and academia to unlock the full potential for its portfolio and create more solutions for patients with cancer.

Job Summary:
The Privacy Manager will support the Privacy Office, Compliance, and risk management functions in building, monitoring, and managing employee and vendor due diligence. Responsibilities will include assessment of policies, procedures, and operations to ensure the organization meets privacy and compliance requirements for the protection of critical information. Duties under the direction of the Privacy department leadership also include analyzing and implementing strategies for improvement. Responsibilities may include delivering training and communicating educational materials that provide guidance on managing privacy protection and mitigating risks related to the unauthorized access of sensitive information. In addition, manager will need to monitor for privacy and healthcare compliance concerns. The Privacy Manager will be responsible for operationalizing key policies and procedures to support and enable the growing SpringWorks organization.

Key Responsibilities:

Assist in creating and maintaining privacy related notices, policies, standards, guidelines and processes.
Conduct assessments, review results and work with stakeholders to mitigate privacy risks across the organization.
Provide privacy guidance, analysis, and feedback to the business partners.
Collaborate with compliance and security professionals on projects related to compliance with global data protection and privacy laws.
Assist in developing and administering privacy training and awareness campaigns for various groups within the company.
Establish and manage tools that track compliance with global privacy obligations such as privacy impact assessments, technical implementation of privacy by design and default, and operational workflows.
Coordinate internal and external audits of our privacy and healthcare compliance systems and procedures.
Provide ongoing management, content development and oversight of the privacy program, including training, risk management, exception handling and process improvement.
Perform other duties and responsibilities as assigned.

Qualifications:

Education: Bachelor's Degree. Certification in privacy or healthcare compliance preferred: IAPP privacy certification (CIPP/US, CIPM, etc.)
Minimum 3 years' experience in health care compliance/privacy sector.
Experience in an Audit, (Privacy, Compliance, Financial) in the pharmaceutical industry is preferred.
Knowledge of healthcare privacy laws and obligations – US State and Federal Laws, HIPAA, GDPR, etc.
Knowledge of healthcare laws and regulations, including the False Claims Act, Anti-Kickback Statute, Sunshine Act, FCPA/UKBA, and privacy laws and regulations.
Knowledge of privacy concepts and practices (strategies, internal controls, information analysis, reporting, including trending and communication).
Embody the SpringWorks Values to act with empathy and humility to drive a culture that takes ownership and accountability for their individual and teams' performance.
Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively and clearly in a remote hybrid work environment.
Ability to travel occasionally including overnight stay driven by business need.
This position must be able to work East Coast hours. #LI-Hybrid

Location Classification – Hybrid:
This role will be required to work onsite 2 days a week (Tuesday and Wednesday), or more depending on business needs.

Compensation:
The expected salary range for this position is $130,000 – $165,000. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

We offer best-in-class benefits for our team of SpringWorkers who work with urgency on behalf of patients suffering from devastating diseases. Interested in learning more, review additional information here Benefits.

DE&I:
We believe in fostering a culture of belonging. Explore how we are committed to DE&I.

EEO Statement:
SpringWorks maintains an EEO Policy providing for equitable opportunities for employment and conditions of employment to all employees and applicants regardless of actual or perceived sex (including pregnancy, childbirth, breastfeeding or related medical conditions), gender, gender identity or gender expression, sexual orientation, partnership status, marital status, familial status, pregnancy status, race, color, national origin, ancestry, caste, religion, religious creed, age, alienage or citizenship status, veteran status, military status, physical or mental disability, past or present history of mental disorder, medical condition, AIDS/HIV status, sickle cell or hemoglobin C trait, genetic predisposition, genetic information, protected medical leaves, victims of domestic violence, stalking, or sex offense, political affiliation and any and all other characteristics or categories protected by applicable federal, state or local laws. SpringWorks treats all employees and applicants fairly in the selection process (and in other personnel activities) by giving all employees and applicants the same opportunities for employment. SpringWorks' Equal Employment Opportunity Policy is intended to ensure that there are no barriers that would prevent members of a protected group from a fair and equitable opportunity to be hired, promoted, or to otherwise take advantage of employment opportunities.

This Equal Employment Opportunity Policy applies to all aspects of employment, including, without limitation, recruitment, hiring, placement, job assignment, promotion, termination, transfer, leaves of absence, compensation, discipline, and access to benefits and training. Any violation of this Policy will result in disciplinary action up to and including termination of employment.

Privacy:
For more information see our Privacy Policy.

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Posted 11/13/2024

ASSOCIATE DIRECTOR (AD), COMPLIANCE OPERATIONS ANIMAL HEALTH (AH) - Boehringer Ingelheim
Location: Based in Duluth, GA US (Atlanta area)

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Associate Director, Compliance Operations - AH is responsible for leading and executing strategic Compliance & Integrity Operations for all Boehringer Ingelheim Animal Health entities in the U.S. to ensure a data-led, risk-based Compliance Program. Directs and coordinates the companies' efforts to comply with laws and obligations that govern its Compliance Program. This role is responsible for developing, implementing, and maintaining a highly effective Compliance Operations program, including optimizing applicable policies & procedures, Training & Communications, Auditing & Monitoring, Investigations, Risk-Assessment, Speak up program, corrective and preventative actions (CAPAs), Transparency, Disclosure & Government Reporting (T&D), Anti-Bribery, Anti-Corruption program (ABAC), FMV evaluations, and Compliance Analytics.

The AD, Compliance Operations - AH serves as the primary contact and provides support for the BIAH Policy Review Committee and provides oversight of data QC. This role is responsible for ensuring the program is continuously improved based on analyzing newly published CIAs and other enforcement actions and industry guidance, regulations, and best practices. The incumbent works collaboratively with, and influences through organizational credibility, senior US Animal Health Business leaders and Corporate/global Compliance leadership to ensure coordinated Compliance operational direction. This role will be an Ethics and Compliance Operations subject matter expert of various internal and external processes and systems associated with his/her assigned responsibilities.

Duties & Responsibilities

Develops, implements, and maintains Compliance systems and tools; drafts, communicates, and maintains policies and procedures.
Develops and executes Compliance Training Program and monitoring strategies and systems.
Oversees all data capture and government reporting obligations (local and cross-border).
Implements and executes Auditing, Monitoring and Risk-Assessment program, including overseeing corrective actions.
Performs all Compliance investigations; evolves and maintains the Compliance analytics program and platforms.
Manages the US ABAC and FMV programs and reports to senior management on Compliance issues.
Defines and directs reporting on key performance indicators.
Prepares and delivers communications to the Board, BIAH Compliance Advisory Council, U.S. Compliance Committee, and other senior executives.
Coordinates with Legal, HR, IT, and other departments to ensure effective management of cross-department compliance controls, including overseeing internal and third-party audits, etc.
Engages stakeholders to develop corrective and preventive actions.
Designs and implements the US-wide compliance auditing, monitoring, and risk-assessment program designed to prevent, detect, and respond appropriately to compliance risks.
Leads and manages progress and outcomes of monitoring activities.
Coordinates the selection of monitoring activities using a data-led, risk-based approach.
Provides oversight to ensure a consistent pattern of complete and accurate records in the appropriate systems.
Designs, implements, and enhances Compliance analytics functionality, including risk-assessment, tracking and quantifying risks and effectively/efficiently deploying and triaging resources to identify, quantify and mitigate company risks.
Oversees selection of all U.S.-wide auditing and monitoring target identification and activities.
Policy and Review Committee (BPRC)Lead.
Accountable for establishing the governance and oversight of the Boehringer Ingelheim Animal Health Policy and Procedure Review Committee (BPRC), a cross-functional committee tasked with reviewing new and existing policies and procedures that are applicable to BIAH entities in the United States.
Ensures policies and procedures are current and approved. Leads the handling of committee meetings and action items.
Leads projects associated with system changes (i.e., Veeva Vault, SharePoint, etc.) that impact document collection, revision, reporting, and monitoring or periodic reviews.
Effectively communicates and delivers formalized training related to these topics across the organization.

Requirements

Bachelor's degree required with a minimum eight to ten (8-10) years relevant work experience, with Animal Health experience preferred; industry certification (e.g., HCCA or SCCE) also preferred.
Expertise and experience in healthcare Compliance Operations, Investigations, ABAC, FMV, process and system implementation for government reporting, compliance data-capture and spend-reporting systems.
Minimum of eight to ten (8-10) years' experience in Compliance within a Healthcare Compliance (or similar) function.
Significant experience and understanding of Animal Health field preferred.
Experience leading and managing an Auditing/Monitoring Program and a clear understanding of the elements of an effective Compliance Program, applicable laws and regulations, enforcement actions and evolving best practices, as well as prior experience overseeing a risk-assessment program.
Must be able to work independently to resolve issues and demonstrate critical thinking and excellent professional judgment.
Demonstrated ability to work collaboratively with others, the agility to rapidly adapt to changing conditions and the ability to drive accountability and results are required. Prior experience with data visualization and analytics software is preferred.
Knowledge and demonstrated experience in training (both in terms of training strategy and training operations).
Demonstrated experience leading projects of material risk/scope/complexity with minimal supervision.
Substantial business, legal and regulatory knowledge, and experience in healthcare industry.
Demonstrated ability to manage and communicate confidential information appropriately.
Strong results-orientation.

Eligibility Requirements

Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required).
Must be 18 years of age or older.

Apply here
Posted 11/12/2024

SENIOR MANAGER, NORTH AMERICAN HEALTHCARE COMPLIANCE - Grifols
Location: North Carolina US/ Hybrid
Contract Type: Regular Full-Time
Area: Legal / Compliance
Req Id: 518370

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

The Senior Manager, North American Healthcare Compliance, works in North America and globally to promote company policy consistent with applicable laws, industry best practice, and ethical values. The Sr. Manager will be responsible for compliance activities for a division/area. The Sr. Manager has expertise in the area, works with minimal oversight, and provides guidance to other team members in the area. The Sr. Manager has experience as an individual contributor and is a developing personnel management skills, becoming an effective team leader.

Primary Responsibilities for Role

Lead transparency reporting program for US
Manage third-party service providers as needed
Participate in and contribute to risk assessment and gap analysis
Lead compliance process development, documentation, and implementation
Support compliance monitoring and auditing program
Create and maintain compliance policies and procedures
Investigate, document and propose solutions for compliance issues and concerns, executing recommendations as appropriate
Develop and provide effective compliance training
Lead AdHoc compliance projects
Lead customer resource for compliance guidance and clarification
Work collaboratively with compliance colleagues to meet company objectives and serve customers

Additional Responsibilities:

Manages a department area.
Manages direct reports (as applicable).
Available for travel 15% primarily within the US.

This job description is intended to present the general requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Knowledge, Skills, and Abilities

Ability to apply US healthcare compliance laws and regulations to complex business situations
Knowledge or experience in US and international commercial operations
Ability to evaluate risk and contribute to monitoring & auditing plan
Ability to recommend and execute corrective action and track implementation
Ability to issue-spot complex issues, explore options, and recommend solutions through strong critical thinking, problem solving, and decision-making skills
Excellent planning, project management, and research skills
Responsible for the work quality of direct reports, as applicable
Exhibits leadership skills for department and team
Strong interpersonal skills
Strong verbal and writing skills
Ability to communicate effectively at all levels of the organization and with partners around the globe
Ability to communicate clearly with direct reports
Strong ethics, concern for standards, and desire to help others do the right thing
Ability to perform duties with the highest degree of confidentiality, objectivity, and fairness
Ability to think strategically and develop and execute strategic plans
Ability to work with limited supervision
Ability to develop quality presentations and deliver presentations to small and moderately-sized audiences
Proficient with standard PC software
Ability to learn specialized software
Ability to train on specialized software
Obtains professional development annually
Looks outside the company to bring in new ideas and best practices
Mentors direct reports on professional development, if applicable
Obtains professional development annually
Looks outside the company to bring in new ideas and best practices
Mentors direct reports on professional development, if applicable

Education:
Bachelors degree, holds at least one compliance certification-or will obtain one within one year of employment-and additional certifications as appropriate for role.

Experience:
Eight years of experience

Equivalency:
Depending on the area of assignment, directly related experience or a combination of directly related education and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience.

Occupational Demands:
Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequently walks. Occasionally bends and twists next. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations and frequently travels within the US. Able to communicate complex information and ideas so others will understand; with the ability to listen and understand information and ideas presented through spoken words and sentences. Frequently interacts with others, relates sensitive information to diverse groups. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.
#LI-TN1

Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.

Location: NORTH AMERICA : USA : NC-RTP:USNC0001 - RTP NC-Headquarters
Learn more about Grifols.

Apply here
Posted 11/11/2024

U.S. ETHICS & COMPLIANCE TRANSPARENCY OPERATIONS MANAGER - Takeda Pharmaceutical
Location: Lexington, MA US/Hybrid Remote

About the role:
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as the U.S. Ethics & Compliance Transparency Manager in our Lexington, MA office.

How you will contribute:

Ethics & Compliance (E&C) will respond rapidly to changing environment and business needs, it is close to the market and encourages ethical behavior in line with Takeda's values. By working in an agile manner E&C ensures the balance between stable structures, governance, processes and systems, and dynamic approaches to delivering innovative solutions to appropriately manage our risks.
E&C commits to act as a role model for Takeda's values, ethics and values-based decision making, fostering this mindset in clients, partners and team
Enable the organization to take decisions which are ethical and in line with our priorities of Patient, Trust, Reputation, and Business
Collaborate across all E&C teams and partner with stakeholders in BU / BF to embed ethics and compliance as part of the way everyone works at Takeda
Act as the business owner of the Transparency system; serve as primary liaison with the system vendor and Takeda IT support team
Program manage issues, exceptions data remediation and system enhancement requests
Lead data collection efforts for Federal and State Transparency reports as well as State Sales Rep and Marketing Disclosure Reports (Nevada, Washington DC, etc)
Prepare, confirm and submit all required State and Federal Transparency-related Reports / Disclosures and FDA Samples report
Develop data analysis and monitoring mechanisms to test, validate, trend, and understand transparency data
Monitor for Federal and State transparency-related limits, caps, and restrictions
Create a cadence for performing monitoring, remediation and analytics (daily, weekly, monthly, etc)
Assist in development of business processes, data taxonomy, and data collection designs and methods that will enable Takeda to support current and future Federal and State disclosure reporting requirements
Assist in communicating transparency-initiative status, progress, and data analytics on an as-required basis to the executive compliance committees
Contribute to the effort to train and manage internal and external users of the Transparency system, including management of third-party vendors who submit data feeds
Collaborate with USBU business areas on process improvement areas identified through transparency monitoring, execution and analytics

Minimum Requirements/Qualifications:

Bachelor's degree required
5+ years of legal, compliance or commercial experience, of which at least 3 years in the healthcare or pharmaceutical industry in a U.S. Transparency-related role
Experience with laws, regulations and industry guidance that affect the pharmaceutical industry including, but not limited to, OIG and PhRMA guidelines, healthcare standard operating procedures, anti-bribery laws
Acute knowledge of Federal and State Transparency Laws and related restrictions
Ability to work with data, databases and reporting platforms
Proficient in PowerBI or Tableau, Excel, and PowerPoint
Excellent written/verbal communication, analytical and presentation skills
Consistently demonstrates the ability to deliver results
Able to work and deliver on deadlines while managing multiple projects and priorities effectively
Ability to rapidly assimilate to new functional scope responsibilities
Strong customer-service skills while interacting with all levels of management, field sales, marketing, marketing and sales vendors and partners

More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

Apply here
Posted 11/6/2024

The Pharmaceutical Compliance Forum

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