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EMPLOYMENT OPPORTUNITIES

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, COMPLIANCE AND ETHICS ORGANIZATION - MEDICAL - Bristol Myers Squibb- Princeton, NJ US (Note: eligible for a hybrid work model with at least 50% onsite at assigned facility)
ASSOCIATE DIRECTOR, COMPLIANCE AND ETHICS ORGANIZATION - WORLDWIDE MEDICAL, R&D AND GLOBAL DRUG DEVELOPMENT - Bristol Myers Squibb- Princeton, NJ US (Note: eligible for a hybrid work model with at least 50% onsite at assigned facility)
ASSOCIATE DIRECTOR, HEALTHCARE COMPLIANCE - Immunocore- Gaithersburg, MD US, Conshohocken, PA US

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.

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.

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 resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center, 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 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.

Apply here
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

DIRECTOR, COMPLIANCE AND ETHICS ORGANIZATION - MEDICAL - Bristol Myers Squibb
Location: Princeton, NJ US (Note: eligible for a hybrid work model with at least 50% onsite at assigned facility)

Job Description:

Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Position Summary:
Reporting to the Head of US and Above Market Compliance and Ethics Organization, this role partners with senior leaders across Legal, Commercial, Medical, R&D, Global Drug Development, Regulatory, IT, Audit, Finance and HR to build and integrate one global compliance program into the US Medical Organization. In this role, you will combine your knowledge about risk mitigation strategies, such as education and monitoring, with data analytics about executional risk to help the business make well-informed, risk-based decisions. You will help operationalize those decisions by crafting simple, clear, principle-based policies. You will educate the business about those policies – and why they exist – leveraging adult-learning techniques that aid retention. And you will use a combination of live monitoring, transactional monitoring, and data analytics to monitor the business's adherence to those policies, helping the business remediate deviations from policies by identifying and addressing the root causes of those deviations. The ideal candidate will be able to execute these tasks with a mindset that believes business functions and Compliance and Ethics are equally accountable for both company success and ethical behavior and will be recognized internally and externally as an expert in mitigating healthcare compliance risk through providing advice, drafting policy, providing education and monitoring execution of high-risk activities.

Responsibilities Include:

Develop and conduct risk assessments utilizing a combination of data analytics, external and internal benchmarking, and review of enforcement trends, to proactively identify the most pressing areas of risk.
Foster trusting relationship with business leaders that enable you to learn of – and advise on – executional risk associated with new initiatives and counsel business leaders about educational initiatives, new policies or monitoring capabilities that can help mitigate risk associated with their decisions.
Analyze data regarding execution of analogous activities to better inform business leaders of the risk associated with their decisions.
Draft simple, easy to understand policies that empower the business to execute activities in an ethical and efficient way.
Develop and provide training that utilizes adult-learning principles, such as gaming, microlearning, and experiential learning, to enhance retention of compliance messages.
Establish a network of Compliance Champions in the respective business unit to integrate compliance messaging and concepts into established business training cycles.
Conduct live and transactional monitoring of business activities.
Determine and allocate budget for training and culture initiatives for specific therapeutic areas.
Identify and leverage key stakeholders and cross-functional resources to create buy-in for training and cultural initiatives for specific therapeutic areas.
Review data to identify outliers and implement preventive education or additional monitoring in response.
Perform other compliance-related activities as directed by the Global Compliance & Ethics team and/or the Head of US and Above Market Compliance.

Qualifications:

Bachelor's degree.
Advanced degree (MBA, CPA, JD) appreciated but not required.
12-15 years pharmaceutical or healthcare related compliance or legal experience, with at least 5 years experience counseling clients.
Working knowledge of relevant US pharmaceutical compliance guidelines, regulations (AKS, FCA, FDCA, HIPAA, FCPA) and PhRMA Code principles.
Familiarity with practices of and intersections between commercial sales, marketing, medical affairs, and market access organizations in the pharmaceutical industry.
Ability to work and communicate with senior level executives with an enterprise mindset focused on achieving company goals in a compliant and ethical manner.
Demonstrated ability to influence business decisions.
Comfort with using data to tell stories particularly around risk and effectiveness of risk mitigation strategies.
Entrepreneurial spirit, taking ownership over the risks and processes you identify and searching for creative solutions.
Proven experience drafting principle-based policies.
Experience utilizing adult-learning concepts in corporate educational and training materials.
Experience conducting live monitoring of speaker programs and advisory boards, and transactional monitoring of engagements with health care providers.
Commitment to a diverse and inclusive workplace.

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through science™ ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Apply here
Posted 10/4/2024

ASSOCIATE DIRECTOR, COMPLIANCE AND ETHICS ORGANIZATION - WORLDWIDE MEDICAL, R&D AND GLOBAL DRUG DEVELOPMENT - Bristol Myers Squibb
Location: Princeton, NJ US (Note: eligible for a hybrid work model with at least 50% onsite at assigned facility)

Position Summary:
Reporting to the Senior Director, US and Above Market Medical and Market Access C&E Lead, this role partners with senior leaders across Legal, Commercial, Medical, R&D, Global Drug Development, Regulatory, IT, Audit, Finance and HR to build and integrate one global compliance program into the Worldwide Medical, R&D and Global Drug Development Organizations. In this role, you will combine your knowledge about risk mitigation strategies, such as education and monitoring, with data analytics about executional risk to help the business make well-informed, risk-based decisions. You will help operationalize those decisions by crafting simple, clear, principle-based policies. You will educate the business about those policies - and why they exist - leveraging adult-learning techniques that aid retention. And you will use a combination of live monitoring, transactional monitoring, and data analytics to monitor the business's adherence to those policies, helping the business remediate deviations from policies by identifying and addressing the root causes of those deviations. The ideal candidate will be able to execute these tasks with a mindset that believes business functions and Compliance and Ethics are equally accountable for both company success and ethical behavior and will be recognized internally and externally as an expert in mitigating healthcare compliance risk through providing advice, drafting policy, providing education and monitoring execution of high-risk activities.

Responsibilities Include:

Conduct risk assessments specific to medical affairs and clinical trial/research activities, utilizing a combination of data analytics, external and internal benchmarking, and review of enforcement trends, to proactively identify the most pressing areas of risk.
Foster trusting relationship with business leaders that enable you to learn of - and advise on - executional risk associated with new initiatives and counsel business leaders about educational initiatives, new policies or monitoring capabilities that can help mitigate risk associated with their decisions.
Analyze data regarding execution of analogous activities to better inform business leaders of the risk associated with their decisions.
Under the direction of the Senior Director, US and Above Market Medical and Market Access C&E Lead, draft simple, easy to understand policies specific to medical affairs and clinical trial/research activities that empower the business to execute activities in an ethical and efficient way.
Under the direction of the Senior Director, US and Above Market Medical and Market Access C&E Lead, develop and provide training specific to medical affairs and clinical trial/research activities that utilizes adult-learning principles, such as gaming, microlearning, and experiential learning, to enhance retention of compliance messages.
Establish a network of Compliance Champions in the respective business unit to integrate compliance messaging and concepts into established business training cycles.
Develop a framework for conducting live and transactional monitoring of medical affairs and clinical trial/research activities.
Review data to identify outliers and implement preventive education or additional monitoring in response.
Perform other compliance-related activities as directed by the Global Compliance & Ethics team and/or the Head of US and Above Market Compliance.

Qualifications:

Bachelor's degree.
Advanced degree (MBA, CPA, JD) appreciated but not required.
8-12 years pharmaceutical or healthcare related compliance or legal experience.
Working knowledge of relevant pharmaceutical compliance guidelines, regulations (AKS, FCA, FDCA, HIPAA, FCPA) and PhRMA Code principles.
Familiarity with healthcare compliance risks associated with clinical trial placement and recruitment, advisory boards, medical congresses and other research and development or medical affairs activities.
Familiarity with practices of and intersections between commercial sales, marketing, and medical affairs organizations in the pharmaceutical industry a plus.
Ability to work and communicate with senior level executives with an enterprise mindset focused on achieving company goals in a compliant and ethical manner.
Demonstrated ability to influence business decisions.
Comfort with using data to tell stories particularly around risk and effectiveness of risk mitigation strategies.
Entrepreneurial spirit, taking ownership over the risks and processes you identify and searching for creative solutions.
Proven experience drafting principle-based policies.
Experience utilizing adult-learning concepts in corporate educational and training materials.
Experience conducting live monitoring of speaker programs and advisory boards, and transactional monitoring of engagements with health care providers.
Commitment to a diverse and inclusive workplace.

Apply here
Posted 10/4/2024

ASSOCIATE DIRECTOR, HEALTHCARE COMPLIANCE - Immunocore
Location: Gaithersburg, MD US, Conshohocken, PA US
Vacancy No: VN497
Employment Type: Full Time
Department: Legal

MAIN PURPOSE OF JOB
Reporting to the Vice President, Compliance, the Associate Director, Compliance will serve an important role in Immunocore's continued enhancement of its Compliance program. This position will provide a broad range of compliance support and work to assist in the implementation, maintenance, and continued improvement of Immunocore's compliant and ethical practices and behaviors through close collaboration with internal and external business partners.

The incumbent is expected to be recognized as an emerging expert, advisor, and subject matter expert across the company in the field of healthcare compliance and to be able to interpret internal or external business challenges and recommending best practices or identifying new solutions.

The Associate Director, Compliance will also have primary responsibility for executing key elements of Immunocore's U.S. Compliance program and ensuring compliance with all applicable laws and guidance.

KEY RESPONSIBILITIES
General

Help identify new work processes, tools or resources that will have broad applicability throughout the organization and assist with the implementation of Compliance systems and processes
Provide training to internal and external organizational clients on a broad range of topics including anti-bribery, FDA regulations, transparency reporting and company policies
Assist in the development and maintenance of relevant Standard Operating Procedures, work instructions, and guidance documents related to key areas within Compliance

Transparency Reporting

Oversee data collection and generation of US and global transparency reports and subsequent reporting of transparency reports to applicable authorities
Maintains understanding of disclosure laws, regulations and applicable industry codes

Auditing & Monitoring

Perform auditing and monitoring of Medical and Commercial activities to ensure compliance with applicable laws, regulations and company policies
Review of Medical and Commercial documentation to ensure compliance with company SOPs and policies
Partner with cross-functional colleagues to address detected noncompliance, including corrective actions when needed

PERSON SPECIFICATION
Experience & knowledge
Essential

Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry including global aggregate spend and other reporting/sunshine laws, fraud and abuse and anti-kickback statutes, OIG and PhRMA guidelines, and state marketing and price reporting compliance laws
Experience with US and global transparency reporting
Experience developing and executing audits and monitoring
Strong operational and project management skills required
Excellent organization, communication and presentation skills. Candidate must have strong team orientation and problem-solving skills
Candidate must be able to work independently and prioritize multiple demands

Desirable

Experience with creating and delivering compliance training for field team and home office colleagues
Experience with participating in compliance investigations

KEY BEHAVIOURAL ATTRIBUTES

Openness and honesty
Readily offering information pertaining to work in hand whether positive or negative.
Taking responsibility
Being prepared to accept full responsibility for tasks entrusted to them; seeing tasks through to completion and dealing with the consequences of failure or success.
Flexibility
Being flexible to new ideas and approaches; changes of plans, objectives and/or priorities. Handling disjointed tasks effectively.
Team spirit
Being able to work productively with others to achieve tasks. Showing consideration for the needs and feelings of others.

SPECIFIC BEHAVIOURAL ATTRIBUTES

Attention to Communication: Ensuring information and work is passed on correctly and in a timely way to those who depend on it.
Written & Oral Communication: Writing and speaking clearly to share thoughts and information concisely and appropriately.
Diagnostic Information Gathering: Identifying the information required to clarify a situation, asking questions when required.
Results Orientated: Focusing on desired results, seeking help and support to overcome obstacles in a timely manner.
Thoroughness: Ensuring work and information provided is complete, carefully checking and seeking additional support to help achieve this if needed.
Managing Self Performance: Works to specific and measurable goals, seeking support and advice when dealing with unfamiliar or new issues.
Analytical Thinking: Tackling day –to-day problems using a logical and systematic approach, identifying discrepancies and inconsistencies.

Education & qualifications

Requires a B.A./B.S. degree or equivalent (Advanced degree preferred) with 7+ years in compliance, audit and/or other related experience required. Pharmaceutical experience required
Certified in Healthcare Compliance (CHC) a plus

Other

This position requires 25% travel
This role is based in our Conshohocken, PA office. Our office-based employees follow a hybrid schedule of 4-5 days in the office.

About the Company:
Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry's most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients' lives, advancing medicine, and supporting one another in these pursuits.

Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.

Apply here
Posted 9/26/2024

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