PCF | Pharmaceutical Compliance Forum

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EMPLOYMENT OPPORTUNITIES

SENIOR MANAGER TO ASSOCIATE DIRECTOR, U.S. COMPLIANCE - Incyte- Incyte Corporate Headquarters
SENIOR COMPLIANCE MANAGER - Lundbeck- Deerfield, IL US
HEALTHCARE COMPLIANCE OPERATIONS ASSOCIATE - TG Therapeutics- Corporate Remote
COMPLIANCE COUNSEL - Otsuka- Princeton
ASSOCIATE DIRECTOR, US COMPLIANCE BUSINESS PARTNER - INSMED- Bridgewater, NJ US
SUSPICIOUS ORDER MONITORING, DATA ANALYTICS - Purdue- Stamford, CT US
COMPLIANCE MANAGER - Lundbeck- Deerfield, IL US
DIRECTOR, US COMPLIANCE - PATIENT SERVICES/MARKET ACCESS - Insmed- Flexible: remote, hybrid or onsite in Bridgewater, NJ US

SENIOR MANAGER TO ASSOCIATE DIRECTOR, U.S. COMPLIANCE - Incyte
Department: Compliance
Location: Incyte Corporate Headquarters

Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.

The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.

Job Summary (Primary function)
The Associate Director, US Compliance is responsible for assisting the U.S. Dermatology and Oncology Compliance Leads with the implementation and management of Incyte's U.S. Compliance Program. This includes supporting efforts to continuously enhance Incyte's Compliance program based on the legal enforcement environment in the U.S. through application of best practices in the life sciences Compliance space. This role requires significant interaction with U.S. Sales and Product Strategy, Legal, Information Technology, Market Access, Medical Affairs, Commercial Operations and other company departments. The Associate Director, US Compliance will report to the Executive Director, Compliance Lead, U.S. Dermatology.

Essential Functions of the Job (Key responsibilities)

Work with the U.S. Compliance Leads to maintain and enhance infrastructure for the U.S. business that supports a company culture of compliance and recognizes that compliance is a collective responsibility of all company employees.
Assist with understanding current and future compliance needs of U.S. business partners.
Develop tools, processes and reports to support the U.S. business's ownership of Compliance.
Assist with managing quarterly U.S. Compliance Committees to track compliance efforts and initiatives and project status updates.
Participate in routine meetings with U.S. business partners.
Participate in the review and approval process of certain core U.S. business activities (e.g., Sponsorships, Advisory Boards, Healthcare Professional engagements, etc.).
Partner with the U.S. Compliance Leads and internal Compliance Policy/Training to identify policy/guideline needs, develop/enhance policies and guidance documents, and ensure optimal accessibility for the U.S. Business using the most up-to-date technology.
Partner with the U.S. Compliance Leads and internal Compliance Policy/Training to create and deliver U.S. Business-specific trainings and communications.
Collaborate with U.S. Compliance Leads and internal Compliance Monitoring/Investigations team to assist with evaluating and remediating monitoring and investigation findings.
Assist the U.S. Compliance Leads with conducting annual compliance risk assessments, including evaluating results and identifying areas of improvement.
Support the U.S. Compliance Leads and Compliance Monitoring/Investigations team by conducting field monitoring activities.
Develop and implement tools to empower business stakeholders to make ethical and compliant decisions.
Provide guidance to the U.S. Business and integrate compliance controls into the scope of existing business practices where applicable.
Develop, lead, and implement continuous improvement activities, including managing documentation and tracking compliance activities.
Maintain a current working knowledge of various laws, regulations, and industry guidance that affect the corporate-wide compliance program, including federal and state government price reporting laws, state and federal privacy laws, OIG and DOJ guidelines, PhRMA code and state marketing compliance laws.
Other duties and special projects as assigned.

Qualifications (Minimal acceptable level of education, work experience, and competency)

Bachelor's degree required.
Minimum of 6 years of pharmaceutical/life sciences compliance experience.
Proven record of accomplishment in the areas of U.S. compliance best practices.
Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry.
Ability to communicate effectively in both verbal and written form with multiple stakeholders within and outside the company.
Ability to collaborate and work effectively with cross-functional teams and projects.
Strategic leadership capability, strong organizational awareness, sound judgment, strong business acumen and ability to make decisions with the input of appropriate input from multiple stakeholders.
Strong problem solving and risk analysis skills.
Ability to effectively prioritize and work in a fast-paced environment and to handle multiple complex and confidential tasks.
Ability to travel up to 25% including overnights and weekends as needed for business meetings and field monitoring activities.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

We Respect Your Privacy
Learn more at: https://www.incyte.com/privacy-policy. The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here.

You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).

Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.

Apply here
Posted 3/24/2023

SENIOR COMPLIANCE MANAGER - Lundbeck
Requisition ID: 4167
Location: Deerfield, Illinois US
Date: Mar 16, 2023

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best. Inspired and driven by our purpose, we are the only global biopharmaceutical company focused solely on brain diseases. We have a robust and innovative pipeline, bringing forward transformative therapies to address unmet needs in neurology and psychiatry. Join us on our journey of growth!

SUMMARY:
This role will 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 work closely with key stakeholders and partner with lines of business (LOB) in support of Compliance and overall business objectives. This role will partner directly with the field-based teams and lead the compliance training program.

ESSENTIAL FUNCTIONS:

Policies, Procedures and Controls, including Code of Conduct: Responsible for ongoing maintenance and updates to steering documents, policies and procedures. Partner with LOB to assist with reviews, development and updating of directives, policies and procedures.
Training, Education and Communications: Lead the compliance training program in accordance with company directives, policies and procedures. Partner with global compliance and LOB to develop, maintain, and ensure appropriate training content, training matrices and training calendars. Deliver appropriate training content and coaching to ensure standards are clearly communicated to employees. Load content and assign, track, maintain and report on trainings related to company directives, policies and procedures. Conduct follow-up to ensure completion of required training. Provide support for compliance communications program.
Business Partnership: Develop and oversee trusted partnerships and effective lines of communication across the commercial organization. Serve as a business partner to the US Neurology field-based teams including sales, field reimbursement support and medical science liaisons. Proactively provide guidance and support to all commercial stakeholders across the organization on compliance matters. Participate in cross-functional initiatives.
Field Compliance Risk Mitigation: Identify and lead strategic projects designed to ensure field compliance with policies and procedures. Provide support for strategy, trend analysis, programs, policies, monitoring, training and corrective actions in support of promotional compliance for the field.
Investigations: Conduct and/or provide support for internal investigations relating to alleged compliance violations. Partner with the Associate Director, Compliance to recommend follow-up and appropriate action.
Monitoring and Auditing: Develop and oversee field force auditing and monitoring initiatives to ensure compliance with Lundbeck's policies and procedures involving speaker programs, advisory boards, sample compliance, and other business activities. Conduct field monitoring, data reviews and audits of key compliance risk areas, in accordance with the US monitoring program. Draft reports and identify appropriate follow-up. Assist with all auditing and monitoring programs and processes to ensure effectiveness of overall compliance program.
Risk Management: Develop and implement ongoing risk assessments, risk analysis and results-oriented risk mitigation plans in support of field compliance and to determine effectiveness of Compliance trainings, education and other initiatives.
System Ownership: Serve as system owner for the electronic learning management system (LMS) and compliance program management software.
Third Party Management: Oversee vendors and third-party RFP processes. Provide support to track vendor budgets, facilitate the execution of vendor contracts and process invoices, as needed.
Advice, Guidance and Other Duties: Proactively provide day-to-day guidance to relevant business units and stakeholders on compliance matters. Help drive a compliant culture. Execute other duties as assigned by Associate Director, Compliance and Chief Compliance Officer.

REQUIRED EDUCATION, EXPERIENCE and SKILLS:

Accredited Bachelor's degree.
5+ years of Compliance-related experience in the pharmaceutical, biotech, medical device or healthcare industry.
Understanding of FDA rules and regulations and Fraud and Abuse Laws, such as the Anti-Kickback Statute and the False Claims Act.
Ability to communicate effectively with individuals at all levels, internally and externally.
Experience in development of training and curriculum design, including delivery and implementation of training and workshops.
Ability to effectively collaborate and problem solve.
Proactive, self-starter with a strong sense of ownership and accountability.
Strong planning, analytical, organizational, and time management skills.
Strong attention to detail.
Ability to function in a fast-paced environment handling multiple tasks simultaneously.
Demonstrated proficiency with Microsoft Office suite, including Excel, Word, and PowerPoint; Internet, or other systems tracking software
The Company requires all employees to be fully vaccinated against COVID-19 as a condition of employment. Newly hired employees must be fully vaccinated against COVID-19 and provide proof upon hire, or request a medical or religious accommodation

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:

3+ years Compliance-related experience in the pharmaceutical industry.
3+ years experience with buy-and-bill systems and reimbursement support programs
Hands on experience supporting a learning management system (Success Factors experience a plus).
Experience administering live web meetings and training sessions with WebEX, GoToMeeting/GoToWebinar, Lync, or other webinar software.
Experience writing quality system documents in a Document Management system (such as Documentum and QDMS).
Product or sales management experience.
Project management experience.
Advanced Excel skills.

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

About Lundbeck
Tirelessly dedicated to restoring brain health, so every person can be their best.

With too many people living with brain diseases around the world, our purpose couldn't be more important or more worth striving for. Every day we work tirelessly to change the outcome for these people. We are a community of specialists fiercely dedicated to restoring brain health, drawing on, and embracing, the uniqueness of every employee.

Our global footprint
Our approximately 5,400 employees in more than 50 countries are engaged across the entire value chain throughout research, development, production, marketing, and sales. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for brain diseases for which there are few, if any therapeutic options. We have research facilities?in Denmark and the United States, and our production facilities are located in Denmark, France and Italy. Lundbeck generated revenue of DKK 18.2 billion in 2022 (EUR 2.5 billion; USD 2.6 billion).

Apply here
Posted 3/21/2023

HEALTHCARE COMPLIANCE OPERATIONS ASSOCIATE - TG Therapeutics
Location: Corporate Remote

Role
The Healthcare Compliance Operations Associate will support the day-to-day operations of the Compliance department. Given the growing and evolving nature of TGTX, and the Compliance Program along with it, this role will support various projects and initiatives including monitoring transactions and engagements , and confirm appliance of newly created controls (policies, SOPs, processes, etc.). They will also assist with related trainings and identify areas of improvement.

This role reports to Associate Director of Healthcare Compliance.

Key Responsibilities
Responsibilities include but are not limited to:

Supporting the general operations of the Compliance Function:

Assisting with execution of Monitoring and Auditing program and any outcomes resulting from monitoring (ie. Associated training, coaching, SOP updates)
Supporting Cross-functional projects and initiatives where Compliance needs to be involved
Supporting creation and implementation of HCC communications
Assisting with aggregate spend transparency reporting
Other duties as assigned

Proactively seek out opportunities to create or streamline processes and improve efficiencies, including potential policy creation and related training and onboarding
Assisting with evaluation of controls, procedures and reporting to identify/mitigate risk
Keeping current in the areas of regulatory, healthcare compliance and ethics

Professional Experience/Qualifications

1-3 years of Healthcare Compliance experience
Familiarity of the Federal and State Laws (ie. False Claims Act), PhRMA Code, Federal Guidance Documents (ie. OIG 7 Elements)
Interested in issues impacting Pharmaceutical and Biotech companies
Confident self-starter with strong interpersonal and organizational skills, with a keen attention to detail
Outstanding written and oral communication skills and ability to work both in teams and independently

Education
Bachelor's degree in related field

If you are interested in the above position, please send your resume to careers@tgtxinc.com and REFERENCE THE POSITION TITLE within the subject line.

Apply here
Posted 3/21/2023

COMPLIANCE COUNSEL - Otsuka
Location: Princeton
Level: Director

Job Summary
Compliance Counsel is the primary liaison between Ethics & Compliance (E&C) and Otsuka's business and operational teams. Counsel provides corporate compliance risk mitigation guidance, serving as a trusted advisor to business team leaders and subject matter experts.

Job Description

Reports to the Senior Compliance Counsel - Senior Director Corporate Compliance in the Ethics & Compliance Department.
Builds partnerships with commercial business and operational stakeholders as well as other risk functions to identify and assess the regulatory risks associated with brand and corporate initiatives, and align on mitigation strategies.
Monitors federal and state legislation, guidance, and enforcement activity to inform risk evaluations and business recommendations.
Collaborates cross-functionally within Ethics & Compliance to support the development of training, monitoring, and remediation tactics.
Creates and updates policies and training to support an effective compliance program, reinforce adherence with industry codes, and foster a culture of integrity.
Oversees compliance with state drug price transparency laws and representative licensure and disclosure requirements.
Develops and presents compliance training to field-based colleagues. Develops and delivers new training content or other methods to ensure all colleagues are educated regarding current developments in compliance, including developing tools for use by the Ethics & Compliance Department.
Supports field monitoring and record auditing activities as needed.
Provides additional support to the Ethics & Compliance team as needed.

Qualifications
Required

Juris Doctorate degree.
At least 5 years of substantive legal and/or compliance experience in the life sciences industry, in-house at a pharmaceutical or medical device company and/or at a firm counseling life sciences industry clients.
In-depth understanding of the laws, regulations, and codes/guidance governing the US healthcare industry as well recent enforcement actions and policy initiatives.
Experience counseling on field promotional tactics; cross-functional initiatives involving promotional, medical, disease education and patient support initiatives; and launch preparedness activities.
Demonstrated achievement identifying and mitigating business risk, educating business partners, collaborating with other risk functions (Legal, Promotion Compliance, etc.) and fostering an organizational culture of integrity.
Experience with government pricing and drug price transparency strongly preferred.
Experience representing Legal or Compliance on multi-disciplinary committees (promotion compliance review, target review, etc.) strongly preferred.
Strong interpersonal, writing, communication, organizational, project management and presentation skills.
Experience in handling confidential and sensitive situations or information with an ability to exercise a high degree of judgment and discretion.
Up to 10% travel based on business needs.

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 receive consideration for employment without regard to their protected veteran or disabled status, or any protected status

Apply here
Posted 3/9/2023

ASSOCIATE DIRECTOR, US COMPLIANCE BUSINESS PARTNER - Insmed
Location: Bridgewater, NJ US
ID: 2023-4951
Salary Range: $140,000.00 to $200,000.00 a year
Can be remote/hybrid

Company Description
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

Recognitions
Named Science's Top Employer in 2021 and 2022
Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey for two years in a row.

A Certified Great Place to Work
We believe our company is truly special, and our employees agree. In July 2022, we became Great Place to Work–certified in the U.S. for the second year in a row. In 2022, we were also listed as the No. 2 company on the Best Workplaces in BiopharmaTM List, Small and Medium, and one of the Best Workplaces in New YorkTM, which recognizes companies headquartered in NY, NJ, and CT.

Overview
The Associate Director, Compliance reports to the Senior Director, US Compliance & Compliance Operations. Supporting US Compliance includes partnering and providing Compliance guidance for Insmed functions including but not limited to Sales, Marketing and Commercial Effectiveness. This role may also have other responsibilities as assigned to support Compliance Operations including HCP Engagements, managing continuous improvements projects and transparency support.

Responsibilities
Additional representative responsibilities will include, but not necessarily be limited to, the following:

Compliance Business Partner

Partner with internal functions including but not limited to, Sales, Marketing and Commercial Effectiveness providing ongoing Compliance guidance and support
Attend Sales, Marketing and Commercial Effectiveness team meetings, actively fostering stakeholder engagement
Partner with Marketing to provide ongoing Compliance guidance and support for the Speakers Bureau, including but not limited to, the review of program materials, oversight of Speaker selection process, deliver Compliance Speaker training and monitor Speaker cap
Oversee the implementation of mitigation plans and processes to facilitate appropriate follow-up and close-out of compliance issues as identified by monitoring and auditing team
Attend Commercial Review Committee as Compliance representative, as needed, responsible for reviewing commercial materials
Responsible for reviewing requests for hiring service providers for ad boards, and other activities for functional areas as assigned
Develop and facilitate Compliance training (e-learning and live)
Develop, review and update Policies and SOPs both Compliance departmental and representing Compliance on functional review of SOPs
Support a proactive approach to compliance that is focused on partnerships, prevention and risk mitigation, develops plan and deliverables to inform relevant internal functions
Raise awareness of the Compliance program and foster accountability for compliance
Build and maintain strategic relationships throughout Insmed
Promote a continuous improvement mindset and propose enhancements to the Compliance Program informed by industry trends and best practices
Coordinate, facilitate, and maintain ongoing relationships with EMEA and Japan Compliance Officers and multiple departments as applicable

Compliance Operations

Provide support for compliance operations areas as assigned

Qualifications

Bachelor's Degree from an accredited institution is required; Additional education/certification within compliance and health-care related fields is preferred.
A minimum of 8 years combined pharmaceutical and compliance experience required
Must have direct experience working in Corporate & Healthcare Compliance at a pharmaceutical or biotech company
High level of familiarity with broad range of compliance risk areas, in particular relating to Commercial practices of a U.S. business
Understanding of compliance internal control concepts and framework.
Maintains understanding of laws and regulations, enforcement actions and evolving best practices relevant to pharmaceutical compliance and proposes updates to Compliance program.
Simultaneously plan, coordinate and supervise various tasks.
Able to manage varying and high workload and sets priorities accordingly.
Inform and liaise with compliance colleagues in reliable and timely manner in relation to all matters.
Detail-oriented, high-energy, and self-sufficient - driving projects to completion independently with the utmost integrity.
Produces high quality work with minimal oversight from Manager.
Possesses a 'can-do' attitude and the ability to work collaboratively across internal stakeholders.
Handles confidential matters with discretion and judgment.
Manages workload and work product to support Manager efficiently and in a solution-oriented manner
Excellent communication and interpersonal skills required. Ability to interact with all levels of the business.
Strong proficiency in Microsoft Office (Word, Excel, PowerPoint) and Outlook

Travel Requirements
Domestic travel required (10-15%)

Salary Range
Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees. The base salary range for this job is from $140,000.00 to $200,000.00

Compensation & Benefits
We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:

Flexible approach to where and how we work
Competitive compensation package including bonus.
Stock options and RSU awards
Employee stock purchase plan
401(k) plan with company match
Professional Judgment Vacation Policy
11 paid holidays per year and Winter Break (typically between Christmas and New Year's Day).

ADDITIONAL U.S. BENEFITS:

Medical, dental, and vision plans
Company-provided short- and long-term disability plans
Company-provided life insurance
Unique offerings of pet, legal, and supplemental life insurance
Flexible spending accounts for medical and dependent care
Accident and Hospital Indemnity plans
Supplemental AD&D
Employee Assistance Program (EAP)
Mental Health on-line digital resource
On-site, no-cost fitness center at our U.S. headquarters
Paid time off to volunteer

Additional Information
Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Please note that we review every submission, and we will keep all submissions on file for six months.

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Posted 3/6/2023

SUSPICIOUS ORDER MONITORING, DATA ANALYTICS - Purdue
Location: Stamford, CT US
Grade: MGT3
Position Reports to: Director, Ethics & Compliance
FLSA Status: Exempt

Job Summary
Responsible for applying analytic techniques to data sets to assess Suspicious Order Monitoring (SOM) risks. This includes retrieving, aggregating, organizing, and interpreting data for insights and to aid the SOM Team in drawing meaningful conclusions from the data. Manage the annual establishment and update of the national average calculation by customer. Also responsible for conducting investigative research using open-source databases, public record and legal database searches, state regulatory websites, etc., and will be required to report findings. Responsible for assisting with reviewing, summarizing, tracking, analyzing, and conducting investigative research relating to SOM.

Primary Responsibilities

Retrieve and analyze data to identify potential controlled substance diversion. Use knowledge of data analytical techniques to determine data sets, find trends/insights, draw logical conclusions, and produce metric reporting.
Utilize data analytical tools such as Google Analytics, Power Point, Power BI, Excel, SQL, and Tableau.
Project manage data analysis for the SOM Team and serve as subject matter expert on data management and analysis.
Create ongoing cumulative and monthly data analysis reports, reflecting trends and percentage increases for specific products.
Articulate data and effectively report results to internal stakeholders.
Manage annual establishment and update of national average calculation by customer.
Research and monitor legal updates and state reporting requirements for SOM requirements.
Develop Standard Operating Procedures (SOPs) and Working Practices Documents (WPDs), as needed, both for Ethics & Compliance Department and other functions.
Assist with state/federal reporting requirements, conducting investigations and preparing timely, accurate and complete reports, as requested.
Manage Import/Export due diligence reporting.
Stay current on ethics and compliance issues/hot topics, as well as industry trends, best practices, federal and state guidance, especially as pertains to SOM.
Provide information, support and background expertise to others within the Ethics & Compliance Department, as applicable, to assist in overall department operations.
Maintain strict ethical, legal adherence and confidentiality at all times.
May also assist with other Ethics & Compliance Department initiatives, including performing audits, training, conducting investigations, assisting with state and federal health care professional (HCP) expenditure reporting, and field-based monitoring.

Education and Experience Requirements

Bachelor's degree required; major in Data Analytics, Communications, Math, Computer Science, Information Management, Finance, Accounting, Statistics, or equivalent preferred
At least 5+ years relevant experience required
2+ years' experience in a role that requires statistical and/or analytical skills preferred
5+ years' experience in a role conducting research and summarizing and conveying findings, both verbally and in writing preferred
Experience in the pharmaceutical industry with knowledge of controlled substance requirements and/or industry experience preferred, including Manufacturing, Distribution, Pharmacy and Health Care Professional interactions
Prior law enforcement and/or investigative experience preferred, particularly with the DEA or other agency, with an emphasis and/or knowledge of the pharmaceutical industry

Necessary Knowledge, Skills, and Abilities

Proven ability to work with substantial amounts of data, facts, and figures to identify, analyze, and interpret trends or patterns in complex data sets.
Ability to efficiently and effectively present data to support conclusions, enabling the Ethics & Compliance team to make informed, data-driven decisions.
Ability to conduct investigative research regarding diversion of controlled substances, supported by familiarity with regulatory websites, license verification and disciplinary histories.
Strong attention to detail, ability to validate work to ensure findings and conclusions are based on accurate analysis. Strong organizational skills, diplomacy, and creativity will be very important to accomplishing the objectives of this position.
Strong analytical and critical thinking skills and the ability to assess and appropriately calibrate levels of risk associated with specific issues.
Proficient in MS Office and various data analysis tools (e.g., Google Analytics, Power Point, Power BI, Excel, SQL, and Tableau).
Integrity, tact, discretion, and the ability to maintain independence, confidentiality, and trust.

Supervisory Responsibilities (if Applicable)
N/A

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Posted 3/1/2023

COMPLIANCE MANAGER - Lundbeck
Requisition ID: 4059
Location: Deerfield, Illinois US
Date: Feb 17, 2023

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best. Inspired and driven by our purpose, we are the only global biopharmaceutical company focused solely on brain diseases. We have a robust and innovative pipeline, bringing forward transformative therapies to address unmet needs in neurology and psychiatry. Join us on our journey of growth!

SUMMARY:
This role will have direct responsibility for and assists with the implementation of all elements of the Lundbeck US Compliance Program, which are modeled after the seven elements of an effective compliance program. This role will work closely with key stakeholders and partner with lines of business (LOB) in support of Compliance and overall business objectives. This role will partner directly with the field-based teams, perform field-based investigations, and conduct auditing and monitoring in support of the compliance program.

ESSENTIAL FUNCTIONS:

Policies, Procedures and Controls, including Code of Conduct: Responsible for ongoing maintenance and updates to steering documents, policies, and procedures. Partner with LOB to assist with reviews, development and updating of directives, policies, and procedures.
Training, Education and Communications: Implement the compliance training program in accordance with company directives, policies, and procedures. Partner with the Compliance team and LOB to ensure appropriate and effective training and education across the organization. Deliver appropriate training content and coaching to ensure standards are clearly communicated to employees. Provide support for compliance communications program.
Business Partnership: Develop and implement trusted partnerships and effective lines of communication across the commercial organization. Serve as a business partner to the US Psychiatry field-based teams. Proactively provide guidance and support to all commercial stakeholders across the organization on compliance matters. Participate in cross-functional initiatives.
Field Compliance Risk Mitigation: Identify and implement strategic projects designed to ensure field compliance with policies and procedures. Provide support for strategy, trend analysis, programs, policies, monitoring, training, and corrective actions in support of promotional compliance for the field.
Investigations: Conduct and/or provide support for internal investigations relating to alleged compliance violations. With supervision, effectively manage all aspects of internal investigations, while ensuring legal compliance and managing risk. Partner with the Associate Director, Compliance to recommend follow-up and appropriate action.
Risk Management: Implement ongoing risk assessments, risk analysis and results-oriented risk mitigation plans in support of field compliance and to determine effectiveness of Compliance trainings, education, and other initiatives.
Monitoring and Auditing: Develop, execute, and enhance field-based auditing and monitoring initiatives involving speaker programs, advisory boards, sample compliance, and other business activities, to ensure compliance with Lundbeck's policies and procedures and effectiveness of overall compliance program. Conduct field monitoring, data reviews and audits of key compliance risk areas, in accordance with the US monitoring program.
System Support: Serve as system support specialist for the electronic learning management system(s) (LMS) and compliance program management software, as needed.
Third Party Management: Manage relevant vendor relationships. Provide support to track vendor budgets, facilitate the execution of vendor contracts and process invoices, as needed.
Advice, Guidance and Other Duties: Proactively provide day-to-day guidance to relevant business units and stakeholders on compliance matters. Help drive a compliant culture. Execute other duties as assigned by Associate Director, Compliance and Chief Compliance Officer.

REQUIRED EDUCATION, EXPERIENCE and SKILLS:

Accredited Bachelor's degree.
3+ years of Compliance-related experience in the healthcare industry.
Understanding of FDA rules and regulations and Fraud and Abuse Laws, such as the Anti-Kickback Statute and the False Claims Act.
Excellent communication, presentation, and interpersonal skills along with an ability to influence both within and outside the organization.
Ability to effectively collaborate and problem solve.
Proactive, self-starter with a strong sense of ownership and accountability.
Strong planning, analytical, organizational, and time management skills.
Strong attention to detail.
Ability to function in a fast-paced environment handling multiple tasks simultaneously.
Demonstrated proficiency with Microsoft Office suite, including Teams, Excel, Word, and PowerPoint.
The Company requires all employees to be fully vaccinated against COVID-19 as a condition of employment. Newly hired employees must be fully vaccinated against COVID-19 and provide proof upon hire, or request a medical or religious accommodation.

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:

3+ years Compliance-related experience in the pharmaceutical industry.
Experience writing and editing documents in a Document Management system.
Experience conducting investigations of alleged misconduct and compliance policy violations.
Experience collecting and analyzing data, including the collection and review of large data sets.
Project management experience.
Advanced Excel skills.

TRAVEL
Willingness/Ability to travel up to 20% domestically. International travel may be required.
#LI-M1, #LI-Hybrid

Why Lundbeck
Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep heritage of discovery and have brought breakthrough therapies to millions of people across the globe. And we're just getting started! Our success is driven by our great people and inclusive culture, which is guided by our beliefs of being Patient-Driven, Courageous, Ambitious, Passionate & Responsible. Are you ready to make an impact, one patient at a time?

Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site.

Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site.

Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.

About Lundbeck
Tirelessly dedicated to restoring brain health, so every person can be their best With too many people living with brain diseases around the world, our purpose couldn't be more important or more worth striving for. Every day we work tirelessly to change the outcome for these people. We are a community of specialists fiercely dedicated to restoring brain health, drawing on, and embracing, the uniqueness of every employee.

Our global footprint
Our approximately 5,300 employees in more than 50 countries are engaged across the entire value chain throughout research, development, production, marketing, and sales. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for brain diseases for which there are few, if any therapeutic options. We have research facilities in Denmark and the United States, and our production facilities are located in Denmark, France and Italy. Lundbeck generated revenue of DKK 16.3 billion in 2021 (EUR 2.2 billion; USD 2.6 billion).

For additional information, we encourage you to visit our corporate website www.lundbeck.com/global and connect with us on Instagram @h_lundbeck, Twitter @Lundbeck and via LinkedIn.

Apply here
Posted 2/20/2023

DIRECTOR, US COMPLIANCE - PATIENT SERVICES/MARKET ACCESS - Insmed
Location: Flexible: remote, hybrid or onsite in Bridgewater, NJ US
ID: 2023-4843
Job Function: Compliance
Salary Range: $208,333.00 to $241,667.00 a year

Company Description
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

Recognitions
Named Science's Top Employer in 2021 and 2022
Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey for two years in a row.

A Certified Great Place to Work
We believe our company is truly special, and our employees agree. In July 2022, we became Great Place to Work–certified in the U.S. for the second year in a row. In 2022, we were also listed as the No. 2 company on the Best Workplaces in BiopharmaTM List, Small and Medium, and one of the Best Workplaces in New YorkTM, which recognizes companies headquartered in NY, NJ, and CT.

Overview
The Director, US Compliance – Patient Services/Market Access reports to the Senior Director, US Compliance & Compliance Operations. This role focuses on partnering and providing Compliance guidance, including privacy with consultation from Insmed Legal, for Insmed US functions including but not limited to Patient Access / Patient Services, Market Access, and Channel Management. This role may also have other responsibilities as assigned to support Data Analytics, Data Governance, and Marketing teams as it relates to the Patient Services Program, including development of materials & dashboards, managing continuous improvement projects and ongoing operations.

Responsibilities
Additional representative responsibilities will include, but not necessarily be limited to, the following:

Compliance Business Partner

Partner with internal functions including but not limited to Patient Services, Market Access, Channel Management and Commercial Effectiveness providing ongoing Compliance guidance and support
Attend cross-functional team meetings, actively fostering stakeholder engagement
Provide guidance for our Patient Services Support Program for new launch product
Oversee the implementation of mitigation plans and processes to facilitate appropriate follow-up and close-out of compliance issues as identified by monitoring and auditing team
Attend US Data Governance Committee as Compliance representative and provide guidance on patient data privacy as needed
Review materials (presentations, training materials, HCP materials, data dashboards, etc.) for Patient Services Program, and other activities for functional areas as assigned
Develop and facilitate Compliance training (e-learning and live)
Develop, review and update Policies and SOPs both Compliance departmental and representing Compliance on functional review of SOPs
Support a proactive approach to compliance that is focused on partnerships, prevention, and risk mitigation, develops plan and deliverables to inform relevant internal functions
Raise awareness of the Compliance program and foster accountability for compliance
Build and maintain strategic relationships throughout Insmed

Promote a continuous improvement mindset and propose enhancements to the Compliance Program informed by industry trends and best practices

Qualifications

Bachelor's Degree from an accredited institution is required; Additional education/certification within compliance and health-care related fields is preferred.
A minimum of 10 years combined pharmaceutical experience required.
Must have direct experience working in Patient Services or Corporate & Healthcare Compliance at a pharmaceutical or biotech company.
High level of familiarity with compliance risk areas, specifically Patient Services practices of a U.S. business.
Understanding of compliance internal control concepts and framework.
Simultaneously plan, coordinate, and supervise various tasks.
Able to manage varying and high workload and sets priorities accordingly.
Inform and liaise with compliance colleagues in reliable and timely manner in relation to all matters.
Detail-oriented, high-energy, and self-sufficient – driving projects to completion independently with the utmost integrity.
Produces high quality work with minimal oversight from Manager.
Possesses a 'can-do' attitude and the ability to work collaboratively across internal stakeholders.
Handles confidential matters with discretion and judgment.
Manages workload and work product to support Manager efficiently and in a solution-oriented manner
Excellent communication and interpersonal skills required. Ability to interact with all levels of the business.
Strong proficiency in Microsoft Office (Word, Excel, PowerPoint) and Outlook.

Travel Requirements
Up to 10% domestic travel

Salary Range
Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees. The base salary range for this job is from $208,333.00 to $241,667.00

Flexible approach to where and how we work
Competitive compensation package including bonus.
Stock options and RSU awards
Employee stock purchase plan
401(k) plan with company match
Professional Judgment Vacation Policy
11 paid holidays per year and Winter Break (typically between Christmas and New Year's Day).

Compensation & Benefits

Medical, dental, and vision plans
Company-provided short- and long-term disability plans
Company-provided life insurance
Unique offerings of pet, legal, and supplemental life insurance
Flexible spending accounts for medical and dependent care
Accident and Hospital Indemnity plans
Supplemental AD&D
Employee Assistance Program (EAP)
Mental Health on-line digital resource
On-site, no-cost fitness center at our U.S. headquarters
Paid time off to volunteer

Apply here
Posted 1/27/2023

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