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EMPLOYMENT OPPORTUNITIES

 

SR MANAGER COMPLIANCE PROGRAMS - Lundbeck Pharmaceuticals
Location: Deerfield, IL US or Remote

SUMMARY:
This role will report directly to the Director, Compliance ("Director") and have direct responsibility for and assist with driving and implementing all elements of the Lundbeck US Compliance Program, which are modeled after the seven elements of an effective compliance program. This role will focus on dedicated, strategic partnership with the home office and work closely with key stakeholders and partner with all lines of business (LOB) in support of organizational Compliance and overall business. Specifically, this role will be responsible for developing, implementing, and executing the Compliance training and communications program, as well as developing and updating healthcare policies, procedures and controls.

ESSENTIAL FUNCTIONS:

• Business Partnership: Serve as a business partner to designated business units across Lundbeck. Proactively provide guidance and support to all stakeholders across the organization on compliance matters. Develop trusted partnerships and effective lines of communication across the company. Participate in cross-functional initiatives. Help drive a compliant culture.
• Policies, Procedures and Controls, including Code of Conduct: In partnership with the Director, develop and update policies, procedures and standards of conduct. Responsible for the drafting, implementation and communication of policies and procedures. Partner with stakeholders to assess the need for and assist with periodic reviews of directives, policies and procedures.
• Training, Education and Communications: In alignment with compliance objectives and Compliance program strategy, responsible for leading the Compliance training, education and communications program. Develop, implement and execute all aspects of the compliance training program. Partner with the Compliance Team and business units to ensure appropriate and effective training and education across the organization. Assist with the development and delivery of appropriate trainings mapped to key risk areas. Responsible for leading the compliance communications program including the development of content and ensuring timely delivery of newsletters and compliance updates utilizing all available communication channels.
• Project Management: Identify and lead strategic projects designed to fulfill the needs of and enhance the effectiveness of the Lundbeck Compliance Program. Drive results-oriented process improvement.
• Risk Management: Support the Director in developing and implementing risk mitigation and enhancement plans; and (2) developing risk assessment protocols for ongoing review.
• Investigations: Assist with internal compliance investigations ensuring legal compliance and managing risk. Assist with escalations as needed. Enforce standards and ensure appropriate follow up action.
• Monitoring and Auditing: Implement effective auditing and monitoring programs and processes to ensure effectiveness of overall compliance program inclusive of policies and procedures, trainings, investigations, and other compliance initiatives.
• Third Party Management: Work with the Director to oversee vendors and third-party RFP processes. This includes managing budget, reviewing, and verifying contract terms with Legal, reviewing invoices, and processing timely payment.
• Other Duties: Assist the Director and CCO with the preparation of reports, summaries and documentation for internal and/or external use and other duties as assigned.

REQUIRED EDUCATION, EXPERIENCE and SKILLS:

• Accredited Bachelor's degree.
• 5+ years of Compliance-related experience in the pharmaceutical, biotech, medical device or healthcare industry or at an agency or consultancy supporting any of these industries.
• 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 with individuals at all levels, internally and externally.
• Demonstrated experience managing projects and working with multi-functional teams.
• 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.
• Keen attention to detail.
• Ability to function in a fast-paced environment handling multiple tasks simultaneously.
• Demonstrated proficiency with Microsoft Office suite, including Excel, Word, and PowerPoint; Internet, or other systems tracking software.

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:

• Compliance-related experience in the pharmaceutical industry.
• Previous experience with compliance training and communications programs
• Experience reimbursement support programs
• Experience administering live web meetings and training sessions with Webex, GoToMeeting/GoToWebinar, Lync, or other webinar software.
• Project management experience.
• Hands on experience supporting a learning management system (Success Factors experience a plus).
• Experience writing quality system documents in a Document Management system (such as Documentum and QDMS).
• Advanced Excel skills.

TRAVEL

• Willingness/Ability to travel up to 15% domestically. International travel may be required. Higher percentage of travel will be required if based remotely.

 Apply here
Posted 4/23/2024

COMPLIANCE MANAGER - Phathom Pharmaceuticals
Location: Florham Park, NJ US

Compliance Manager
Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal (GI) diseases. We have licensed the exclusive rights in the United States, Europe, and Canada to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB). Phathom currently markets VOQUEZNA® (vonoprazan) tablets for the treatment of Erosive GERD and associated heartburn in adults, as well as VOQUEZNA® TRIPLE PAK® (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules) for the treatment of H. pylori infection in adults. In addition, the company is actively investigating the use of vonoprazan as a treatment for Non-Erosive GERD, with a New Drug Application currently under review by the FDA and a separate Phase 3 trial planned to initiate in 2024.

We believe we can change the status quo of treatment for acid-related disorders and have assembled a team of seasoned GI and pharmaceutical industry experts with deep expertise in developing blockbuster therapeutics, including anti-secretory agents. Our team of highly driven professionals are passionate in our mission to address unmet needs for patients and improve their quality of life. Phathom is looking for self-motivated, creative problem solvers who are excited by the idea of working in a fast-paced environment and contributing to our growth.

The Manager, Compliance will be responsible for supporting the Compliance Team and activities related to Pharmaceutical Healthcare Compliance and will report to the Director, Legal and Compliance. We are seeking candidates with strong communication skills, analytical acumen, attention to detail, and interest in being fundamental to the success of the overall organization. We welcome candidates with various background experience, with a focus on those driven to learn and excel.

Accountabilities:

• Developing and managing relationships with stakeholders at all levels of the business and playing a lead role in embedding a good compliance culture
• Performing routine compliance monitoring and periodic compliance audits to evaluate organizational compliance with its policies, procedures and applicable regulatory standards. Collaborates with impacted parties to develop and implement corrective action plans to address monitoring and audit findings.
• Responsible for the execution of day-to-day Spend Transparency program activities, including but not limited to program governance and compliance, proper spend data capture practices, support for certification and submission, inquiries and dispute resolution, training, communications, monitoring, auditing and data analytics.
• Maintain company compliance policies and procedures - work with team members to ensure they understand their roles and responsibilities defined in the specific compliance-related policies and procedures.
• Coordinate with supporting consultants and third party vendors to drive compliance activities.
• Oversee portfolio of required business licensed to ensure they are properly maintained and meet compliance and regulatory requirements.
• Serve as administrator and/or liaison to multiple data repository/reporting systems including those related to transparency reporting and data analytics
• Provide advice and support to business units on reporting and documentation requirements
• Partner with third-party vendors to continuously improve reporting systems and practices
• Other compliance-related tasks as assigned

Education & Experience:

• Bachelor's degree and a minimum of 4 years experience, some of which should ideally be healthcare/compliance experience in Life Sciences field, or equivalent combination of education, training, and experience.
• Knowledge of PhRMA Code, FDA, and OIG standards governing the sales and marketing of pharmaceuticals.
• Knowledge and experience in producing transparency reports and working with aggregate spend data reporting systems.
• Excellent interpersonal and communications skills.
• Project management experience preferred.
• Experience in drafting policies and managing compliance training programs preferred.
• Strong track record of working in a collaborative environment with demonstrated evidence of maintaining relationships and partnerships with peers and business partners required.
• Healthcare Compliance Certifications a plus
• Highest level of integrity and ethics, and a commitment to maintaining the highest standards of compliance
• Strong written and oral communication skills, including the ability to communicate complex concepts to all organizational levels, including senior management.

 Apply here
Posted 4/22/2024

SR. MANAGER, COMPLIANCE - SUN PHARMA
Location: Princeton, New Jersey US (ON-SITE: Hybrid 3 days in office; 2 days remote)

Sr. Manager, Compliance
The Sr. Manager will be responsible for state price transparency reporting to state regulatory authorities, including administration of the reporting system and maintenance of all data. The individual will partner with the business to assemble and maintain accurate and complete records of pricing data and any related changes and serve as an advisor regarding potential price increases. They will also be responsible for DEA compliance monitoring and reporting in compliance with laws and regulations.

Key Responsibilities

• Serve as administrator of multiple data repository/reporting systems including those related to state price transparency reporting and DEA monitoring
• Provide advice and support to business units on reporting and documentation requirements
• Maintain data consistent with regulatory authority requirements and in a readily accessible format
• Stay up to date with changes in monitoring or reporting requirements under state price transparency reporting and State and Federal DEA laws, rules and regulations and communicate changes to impacted business units
• Serve on cross-functional committees responsible for making pricing decisions and provide information required for compliant decision making
• Submit all required reports in accordance with statutory requirements
• Develop and maintain dashboards and reports
• Partner with third-party vendors to continuously improve retention and reporting systems
• Revise Company policies and procedures as needed
• Develop and deliver training to applicable business unit stakeholders
• Other compliance-related functions as assigned

Qualifications

• BS/BA degree required
• 3 - 5 years of compliance, audit, legal, consulting or related professional experience within the pharmaceutical industry
• DEA compliance and/or Government Pricing preferred
• Knowledge of the laws, regulations, guidelines and codes impacting the industry
• Strong planning and organization skills with the ability to lead and manage multiple projects concurrently
• Excellent organizational, analytical and communication skills with the ability to support stakeholders at all levels
• Strong interpersonal and presentation skills and the ability to build relationships across all levels of an organization
• Proficiency in Microsoft Office is required (e.g., Word, PowerPoint, Excel, Teams)
• Travel between Company U.S. facilities on at least a quarterly basis to be expected. Minimal additional travel may be required

 Apply here
Posted 4/15/2024

DIRECTOR, COMPLIANCE - Ferring Pharmaceuticals
Location: Parsippany, New Jersey, US
Job Requisition ID: R0028344
Full time

Job Description:
As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our 'people first' philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world's oldest enemy: disease.

Ferring is on a mission to transform the treatment of bladder cancer with a novel, first-in-class intravesical gene therapy that provides patients with an alternative to bladder removal surgery. Our Uro-Oncology team is growing with a variety of rewarding opportunities in commercial, medical affairs and technical operations. If you are energized by the prospect of bringing the benefits of cutting-edge science to meet the needs of patients, we may have the perfect role for you.

As the Director, Compliance you will create risk-based compliance strategies and ensure comprehensive compliance support of assigned functions within our Uro-Oncology organization.

This is your opportunity to play an important role in making available to patients a novel product that has the potential to revolutionize the treatment of bladder cancer!

With Ferring, you will be joining a recognized leader, identified as one of "The World's Most Innovative Companies" by Fast Company, and honored by Fortune with inclusion on its "Change the World List," for addressing society's unmet needs. Ferring US is also Great Places to Work® Certified, distinguishing it as one of the best companies to work for in the country.

Responsibilities:

• Independently provide compliance guidance on promotional and non-promotional materials, scientific exchange, disease state, medical/scientific programs and R&D activities to minimize company risk and facilitate compliance that is in alignment with applicable regulations.
• Develop and execute an engagement and integration plan in symphony with other Compliance Associate Directors as well Compliance Directors for US Compliance to incorporate requirements and training into commercial operations, and vendors, based on identified gap analyses and risks assessments or potential areas of compliance vulnerability.
• Embrace and implement opportunities to rethink how Compliance services are provided, focusing internal expertise on complex, high value matters, and automating, streamlining, or outsourcing high-volume, lower complexity matters, and using data to drive continuous improvement in services.
• Foster a company culture that focuses on compliance and ensures on-going commitment to the Ferring Philosophy
• Act as the Compliance lead for:
• business support teams, including Legal, Regulatory, and Human Resources, to establish requirements and guidelines in support
• non-commercial employees.
• Uro-Oncology commercial and non-commercial teams. Provide input on compliance matters to live during in person and virtual meetings or via written materials to for key stakeholders and senior leadership.
• the evaluation and implementation of SOPs, policies, and training as well as contribute to related standards and guidelines for concept and activity reviews to field implementation.
• Monitor commercial and non-commercial programs and business processes to ensure adherence to company's policies and procedures in a manner that is consistent with best practices and applicable laws and guidance.
• Develop and implement or update policies, SOPs, guidelines, and associated internal communications related to non-promotional, medical/clinical programs, including congress activity, educational programs, use of publications and reprints, commercial medical interactions, advisory boards, ad hoc consulting, IITs, clinical trials, Mock FDA meetings, etc.
• Review and approve annual engagement plans and business need reviews for HCP engagements and other interactions incoming from the Commercial Operations, Sales and Marketing departments of all Business Units
• Act as a representative on select cross functional teams or Committees as assigned for matters relating to Commercial Compliance including task forces.

Requirements:

• Minimum 10 years of Compliance, Legal Regulatory or related work experience, with at least 5 years' in the pharmaceutical industry.
• Bachelor's degree required, advanced degree preferred.
• Demonstrated experience supporting complex products in oncology, rare disease, buy & bill, medical device, or injectables.
• In depth understanding of PhRMA Code; Federal Food, Drug, Cosmetic Act; Anti-Kickback Statute; and federal and state transparency and disclosure laws.
• Knowledge of industry compliance activities, regulatory landscape, pharmaceutical compliance training and monitoring programs.
• Demonstrated experience and creating and delivering effective compliance training
• Strong interpersonal skills, platform skills, and written and verbal communication skills
• Experience with implementation of risked-based compliance programs and understanding of US pharmaceutical/device and other regulations.
• Works well across multiple functions and therapeutic areas
• Demonstrated ability to develop, launch, deliver, and measure various forms of training
• Proficient technology skills, etc.
• Position requires excellent written and verbal communication, motivational, interpersonal and time management skills.
• Travel 20-30%

Ferring + you
At Ferring, we offer competitive total compensation along with an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work. From working hours that respect your lifestyle, a culture that is welcoming and equitable, and the chance to work with the industry's most impressive people, these are just some of the ways we live our "People First" philosophy.

Our Compensation and Benefits At Ferring, base salary is one part of our competitive total compensation and benefits package and is determined using a salary range. The base salary range for this role is $174,000 to $254,150, which is the reasonable estimate of the base compensation for this role. The actual amount paid may differ based on non-discriminatory factors such as experience, knowledge, skills, abilities, education and primary work location. Additional compensation for this role will be provided based on competitive annual incentive compensation targets in the form of an annual bonus - payouts are based on individual and company performance.

Benefits for this role include: comprehensive healthcare (medical, dental, and vision) with a premium differential, inverse to base salary, to be paid by employees; a 401k plan and company match; short and long-term disability coverage; basic life insurance; wellness benefits; reimbursement for certain tuition expenses; sick time frontloaded yearly of 40 hours, or higher if state or local law requires; vacation time for full time employees to accrue between 112.5 and 150 hours yearly in the first four (4) years of employment, and additional accruals starting in the fifth (5th) year of employment; and 12 to 13 paid holidays per year. We are proud to offer 26 weeks of paid parental leave, learn more about the parental leave offering in our benefits package here. For roles that are not field-based, Ferring has a policy that allows employees to work up to two days from home and three at a Ferring site, weekly.

Ferring is an equal opportunity employer. All aspects of employment will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of gender, race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local laws.

Join our team and your voice will be heard, and your contributions will be valued. If you love to come up with new ways to make a positive difference and see them through, you will fit right in.

We are proud to be an Affirmative Action/Equal Opportunity Employer (including Disability/Protected Veterans). We maintain a drug-free workplace.

 Apply here
Posted 3/19/2024

SENIOR MANAGER - COMPLIANCE DATA ANALYTICS - Regeneron
Location: Open for hybrid work - 3 days / wk. onsite at our HQ Campus in Sleepy Hollow, NY. This is not available as a fully remote role.

The Senior Manager - Compliance Data Analytics will be a key member of the Compliance Monitoring Team and collaborator within the implementation of Regeneron's compliance monitoring plan. The role will leverage business intelligence tools & data visualization platforms (e.g., QlikView, Tableau, Oracle BI, Veeva CRM) in reviewing complex data, records and systems relating to interactions with healthcare professionals and institutions. It requires an understanding of healthcare laws, fraud and abuse laws, as well as the compliance enforcement environment. The position will incorporate sophisticated analysis and apply a business context for non-analytical audiences, key business partners and departmental leaders across Regeneron.

This role is open for hybrid work - 3 days / wk. onsite at our HQ Campus in Sleepy Hollow, NY. This is not available as a fully remote role.

A typical day may include:

• Implementation of the compliance monitoring plan via review of complex data, records and systems relating to Regeneron's interactions with healthcare professionals and institutions.
• Interacting with business leaders around effective business process and systems advancements
• Working with developers and end-users to obtain the necessary data from different systems to address and inform compliance monitoring needs
• Creating new reports, dashboards, and / or analytics processes through data validation, analysis, and trends
• Acquiring data from primary or secondary data sources and maintaining databases/data systems
• Filtering and "cleaning" data, and reviewing computer reports, printouts, and performance indicators to locate and correct code problems
• Documenting structure of company business data, which serves as a guide in execution of tasks
• Monitoring dashboards and reports to identify potential risk requiring further review and building out the key risk indicators to track potential concerns
• Review and follow-up on suspected areas of non-compliance in collaboration with Company business leads and investigations team, as needed
• Assist with preparation of data analyses for quarterly and ad hoc compliance reports and, presentations to develop actionable insights and messaging to Leadership

This role may be for you if possess:

• Strong critical thinking, problem-solving and decision-making skills
• Proficiency in big data analysis, development and maintenance of relational databases, and/or building complex queries and macros
• Demonstrated skills in data analysis and project management with strong attention to detail
• Effective time management and organization skills required to manage multiple projects at one time and meet deadlines
• Self-motivation in your work, whether independently or collaboratively
• Uncompromising ethics and a high standard of personal integrity

To be considered for the is role you must have a BS/BA with an Advanced Degree in a quantitative subject (e.g., Statistics, Computer Science or related field) being preferred. A minimum of 7 years of experience with 3+ years analytical experience within pharmaceutical / biotechnology industries related to commercialized products and/or a compliance setting. Demonstrated knowledge and understanding of the Anti-Kickback Statute and False Claims Act, FDA rules and regulations regarding the promotion of pharmaceuticals, corporate integrity agreements, PhRMA code, and other relevant reporting/legal requirements. Commercial business intelligence tools & report creation experience is required (e.g., QlikView, Tableau, Oracle BI, Veeva CRM). Presentation skills to take sophisticated analysis and apply a business context for non-analytical audience required. Knowledge of artificial intelligence and machine learning, is a plus.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)
$129,800.00 - $211,800.00

 Apply here
Posted 2/14/2024

ASSOCIATE DIRECTOR, ENTERPRISE RISK MANAGEMENT (ERM) AUDITOR - Otsuka America Pharmaceutical, Inc.
Location: Remote

Following implementation of the Enterprise Risk Management (ERM) program in the US and the output of the first ERM risk assessment, this new role is being created to develop and build a US Ethics & Compliance (E&C) ERM audit program.

The Associate Director, ERM Auditor will lead the development of the ERM audit strategy and planning, execution, and reporting of ERM audits and other reviews on behalf of Otsuka America Pharmaceutical, Inc. (OAPI) and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC). This will support effective risk management and compliance by providing assurance services through audit and review of Otsuka's enterprise and US compliance risks. This is a key role to continue to evolve E&C's Healthcare Law Auditing and Monitoring (HLAM) function to support the Chief Compliance Officer in executing an effective compliance program.

Job Description
The Associate Director, ERM Auditor will be responsible to:

• Develop and implement a US Compliance audit program that provides assurance over Otsuka's enterprise and US compliance risks and helps to detect and prevent fraud.
• Develop and maintain the annual audit plan (and audit universe) through engagement with senior leaders in E&C, Legal, and other key US business stakeholders to ensure it is focused on the highest-risk activities and remains fit-for-purpose.
• Lead audits and other reviews of Otsuka's enterprise risks and framework, by assessing the design and operating effectiveness of internal controls (through detailed transaction testing) to identify control gaps or risks.
• Develop and execute audit process steps, including drafting announcement memos, designing audit testing procedures, interviewing stakeholders, reviewing and testing internal controls, executing sampling methodology, reviewing supporting documentation, and documenting testing procedures, findings, and observations.
• Validate audit findings and observations with management and communicate final audit results to senior management, through presentations and written reports that address findings, risks, root cause analysis, and recommendations.
• Draft formal written audit reports or other Compliance reports for the US business that are clear, concise, and drive meaningful action to strengthen controls and mitigate enterprise risks.
• Directly manage 3rd party consultants and actively oversee audits conducted by third parties on Otsuka's behalf, ensuring audit quality and on-time delivery.
• Partner with US E&C Compliance Counsel and other functional areas to recommend pragmatic risk mitigation or remediation actions. Establish and maintain effective relationships with internal stakeholders and collaborate with internal partners on compliance matters.
• Assist Executive Director and Senior Director, Governance, Risk and Compliance (GRC) with the execution of the enterprise risk management framework, as needed.
• Provide feedback and/or draft sections of reports and documents intended for submission to various organizational committees, including the US Chief Compliance Officer, OAPI/OPDC Board of Directors, and Audit Committee of the Board.
• Maintains 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.
• Identifies opportunities and supports further development of the COMPLi system, Otsuka's E&C data analytics platform (e.g., new reporting dashboards or risk indicator metrics).
• Directly manage at least 2 full time employees (FTEs), which includes providing oversight, coaching, ensuring completion of training, and creating and managing team goals.
• At the direction of US E&C Leadership team, perform any other duties as identified by the members of the US E&C Leadership.

Qualifications:
Required

• At least 8-10 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.
• Experience with regulators, external auditors, 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.
• IT audit experience is preferred.

 Apply here
Posted 2/2/2024

ASSOCIATE DIRECTOR, COMPLIANCE INVESTIGATIONS PHARMA - Boehringer Ingelheim
Location: Remote
Internal ID: 7834

Description:
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.

Join us on our journey at https://www.boehringer-ingelheim.com. Every day our scientists are charting new territory and continuing our commitment to innovation that has created exceptional medicines that have changed the lives of millions of patients.

Investigations are critical to ensuring the Company has an effective compliance program. The Code of Conduct requires employees to report suspected or actual violations of law, the Code of Conduct or policies and procedures. The Company needs to have an effective investigation process to address all reports of non-compliant activity.

The AD Compliance Investigations (Investigator) will:

• Conduct and manage compliance investigations into potential violations of laws or regulations, policies and procedures, the Code of Conduct and/or ethical standards.
• Serve as a subject matter expert on compliance investigations.
• Promote Ethics & Compliance as an independent, confidential, and trusted resource for employees to report health care compliance concerns.

This is a remote position.

Duties & Responsibilities:

• Conducts and manages compliance investigations concerning various forms of alleged misconduct and non-compliance or unethical behavior related to violations of the Code of Conduct, policies or procedures, laws or regulations.
• As part of the investigation process, conducts interviews, analyzes evidence, reviews applicable background documentation, reads and interprets applicable policies and procedures, and collaborates with investigatory and business stakeholders, while maintaining strict confidentiality.
• Manages large case load of investigations in a prompt, thorough and professional manner.
• Maintains confidentiality and sensitivity.
• Prepares timely, accurate, and complete written case summary reports.
• Presents investigation case summary reports at investigation review committee meetings in a concise, meaningful and organized fashion. Presentation shall include identification of potential non-compliances and the initial assessment of the ramifications of risks to the Company.
• Partners with Human Resources and Employee Relations business partners to ensure that corrective action plans are implemented.
• Conducts root cause analysis to understand factors contributing to potential policy or procedure violations.
• Develops recommendations of additional compliance controls and remediation activities for identified gaps.
• Conducts trend analysis to prepare actionable insights shared with key stakeholders.
• Reviews trends and make recommendations and proactive approaches to minimize future investigations.
• Develops and presents investigation-related trainings within Ethics & Compliance.
• Ensures transparency into the process with impacted business stakeholders.
• Collaborates with key functional area stakeholders to ensure maintenance of investigative protocols and policies.

Compensation Data:

This position offers a base salary typically between $135,000 and $232,000. The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements. For an overview of our benefits please click here.

Requirements:
Minimum Education/Degree Requirements:

• Bachelor's degree from an accredited institution required.
• JD degree from an accredited institution strongly preferred.

Required Capabilities:

• Minimum five (5) years of directly related experience in compliance investigations with demonstrated independent oversight required.
• Must have actual experience in conducting and leading complex investigations from commencement to conclusion, and accountability for individual case management.
• Minimum of five (5) years of pharmaceutical company relevant experience.
• Must understand the legal and compliance risks inherent in pharmaceutical industry and have the capability to learn the policy and procedure framework at the Company and utilize independent critical thinking to identify additional issues and potential risks when collecting evidence.
• Ability to effectively manage a significant caseload with multiple, concurrent projects under tight/required deadlines.
• Ability to interact appropriately with all levels within the organization and engage in 'careful communication', exercise excellent judgment and maintain discretion and confidentiality.
• Ability to serve as a subject matter expert on investigations.
• Ability to apply and maintain progressive knowledge of investigative techniques compliant with government laws and regulations.
• Ability to independently lead complex investigations where the facts may be ambiguous and/or unknowable and to take well-reasoned and carefully documented conclusions is essential to the performance of this role.
• Possesses excellent technical skills, and very strong emotional intelligence (EQ) and interpersonal skills to effectuate investigations in a way that limits any potential negative impact on the employees.
• Ability to distill a high volume of facts to prepare well-documented summaries with cogent analysis.
• Demonstrated ability to influence, communicate effectively in writing and during presentations, and build relationships at all levels.
• Excellent interpersonal skills.
• Must possess the highest ethical standards.

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 or older.

Who We Are:
At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family-owned company, we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative, and inclusive culture.?Learning and development for all employees is key because your growth is our growth.

Want to learn more? Visit https://www.boehringer-ingelheim.com and join us in our effort to make more health.

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients, and communities. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

 Apply here
Posted 1/26/2024

COMPLIANCE MANAGER - Kiniksa Pharmaceuticals
Location: Lexington, MA

Job Summary
Reporting to the Associate Director, Compliance, the Manager, Compliance will serve an important role in Kiniksa's continued enhancement of its Compliance program. This position will work to assist in the implementation, maintenance, and continued improvement of Kiniksa's compliant and ethical practices and behaviors through close collaboration with internal and external business partners. The Manager, Compliance will also be primarily responsible for executing key elements of Kiniksa's auditing and monitoring program.

This role is based in our Lexington, MA office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.

Responsibilities (including, but not limited to):
Auditing & Monitoring

• Assist in developing auditing and monitoring plans
• Conduct in-person monitoring of Medical and Commercial activities to ensure compliance with applicable laws, regulations, and company policies
• Conduct desk monitoring of Medical, Clinical, Commercial, and other departmental activities to ensure compliance with applicable laws, regulations, and company policies
• Review of Medical, Commercial, and other internal documentation to ensure compliance with company SOPs and policies
• Track and report progress of Compliance auditing and monitoring, including preparation of reports/presentations/metrics to communicate findings throughout multiple levels of the organization
• Maintain knowledge of industry and enforcement trends and regulations to continuously inform and improve auditing and monitoring tools and templates
• Maintain relevant auditing/monitoring systems, tools, and dashboards

Other Responsibilities

• Work alongside employees and company leadership to maintain and further develop throughout the organization a strong culture of ethics and compliance, including personal accountability at all levels in the organization, with a spirit of partnership and positive problem solving
• Requires the ability to be flexible and adaptable to changes. This individual must feel comfortable in creating new processes and grow with organizational and regulatory changes
• Optimize compliance data analytics and assist in the development of data analysis tools and systems to maximize departmental efficiency
• Maintain awareness of applicable laws and regulations and keep current with changes that may affect Kiniksa's Compliance program

Qualifications

• 3 - 5 years in compliance, audit, monitoring and/or other related experience required. Pharmaceutical experience required
• B.A./B.S. degree or equivalent required. Advanced degree preferred
• Certified Fraud Examiner (CFE), Certified Internal Auditor (CIA), Certified in Healthcare Compliance (CHC), or Project Management Professional (PMP) a plus
• Experience developing and executing audits and monitoring activities
• Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry including fraud and abuse and anti-kickback statutes, OIG and PhRMA guidelines, and state marketing compliance laws
• Experience with risk assessments and business continuity planning preferred
• Experience managing complex projects with a strong attention to detail
• Strong operational and project management skills required
• Excellent organization and presentation skills. Candidate must have strong team orientation, decision making, and problem-solving skills
• Demonstrated strong written and verbal communication skills
• Proven mindset of proactive continuous improvement
• Efficient independent worker with ability to focus and drive for results
• Ability to work in a fast paced-environment and to handle multiple tasks
• Strong commitment to compliance and ethical standards
• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.), as well as previous significant experience using report building software such as Tableau, Smartsheet, Cognos Report, Query Studio, or a similar software package
• Ability to travel up to 50%

Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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Posted 1/26/2024