The Pharmaceutical Compliance Forum

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EMPLOYMENT OPPORTUNITIES

 

COMPLIANCE OPERATIONS MANAGER - Incyte
Location: Wilmington, DE US

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 Compliance Operations Manager is responsible for managing various systems and operational aspects of Incyte's global Compliance program with an emphasis on Compliance training, communications, and policies. The position will be responsible for developing, documenting, and tracking training and education of employees and external third parties, planning and developing internal communication activities and maintaining and managing Incyte's corporate policies. Additional responsibilities include managing other Compliance systems used to track and document Incyte's Compliance activities and preparing various reports related to the Compliance department activities.


Essential Functions of the Job (Key responsibilities)

  • Assist with the development of live and module training and communications for Incyte's Compliance program.
  • Manage Incyte's corporate policy inventory and employee training matrix, including facilitating the appropriate review and approval process for new or revised policies. Assist with regularly assessing key policies and procedures to mitigate identified risks and to meet government, industry, and company compliance requirements.
  • Manage the learning and document management systems used for trainings and policies, including training launches, completion tracking, and appropriate document retention.
  • Manage other Compliance systems including the policy exception process, Compliance mailbox, conflict of interest log, and other systems that may be developed.
  • Routinely work with global and regional functions to coordinate and execute policy, training, and communication efforts. Work with translation vendors to translate materials as needed.
  • Maintain and update internal and external facing web platforms that support the Compliance function.
  • Assist with the preparation of readouts, slide decks and dashboards related to compliance operations and progress.
  • Contribute positively to a strong culture of compliance and ethics.

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

  • Bachelor's degree preferred.
  • Minimum five years relevant experience with three + years of pharmaceutical company compliance experience preferred.
  • Working knowledge of laws, regulations, and industry guidance that affect the pharmaceutical industry including federal and state government price report laws, fraud and abuse and anti-kickback statues, OIG and PhRMA guidelines, state marketing compliance laws, the Foreign Corrupt Practices Act, the UK Bribery Act, and other anti-bribery laws preferred.
  • Ability to work in a fast-paced environment and to handle multiple complex and confidential tasks. Strong detail orientation and focus on quality work product.
  • Strong written, oral communication, interpersonal, and organization skills.
  • Self-motivated, solution-oriented and adaptable.
  • High level of professionalism, integrity and ability to maintain confidences while working with sensitive, confidential information.
  • Experience working with affiliates outside of the US a plus.

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.

 Apply here
Posted 1/16/2020

SR. MANAGER GLOBAL COMPLIANCE - Incyte
Location: Wilmington, DE US

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)
This position will include management and support of Incyte's Global Corporate Compliance Program, with significant interaction with Incyte's US business, Global and Regional functions, Country Management and other departments. This position will work to continuously enhance Incyte's Compliance program through application of best practices in the life sciences Compliance space.


Essential Functions of the Job (Key responsibilities)

  • Support the development, enhancement and implementation of Incyte's Compliance program elements across regions and markets with a view toward global harmonization.
    • In collaboration with EU, US and other Regional and Country Compliance leads, contribute to development of global compliance annual plans and priorities based on risk assessments and other relevant inputs.
    • Draft, coordinate and help implement global, regional and/or local Compliance policies, SOPs and other Compliance tools and templates.
    • Support development and delivery of live and/or recorded compliance training.
    • Support global compliance efforts by participating in the design and development of compliance monitoring activities.
    • Conduct Compliance reviews of certain business activities, e.g. external funding requests.
    • Represent Compliance at key business meetings and industry events.
    • Provide ongoing support to general compliance projects and processes as necessary.
  • Support Incyte's global anti-bribery anti-corruption (ABAC) program including policy, training and process needs.
    • Manage and implement enhancements to Incyte's third party due diligence processes, including management of system, third party risk criteria, ordering and review of diligence, developing mitigation actions in collaboration with the business, and ongoing monitoring of higher risk third parties.
    • Work cross-functionally to support Incyte's efforts to continuously enhance third party man
  • Support development and implementation of new Compliance programs in new markets.
    • Assist in development and implementation of compliance plans for new affiliates and/or partners in new, global markets.
    • Provide guidance to new affiliates and/or partners, and integrate compliance controls into the scope of these businesses as applicable with a focus on global harmonization and "right sizing" the program.
  • Provide regular updates to Global, EU and US Compliance Leads, and provide input into quarterly Global & US Compliance Committee meetings and bi-annual Audit Committee meetings. Help prepare and deliver regular compliance program readouts, slide decks and dashboards.
  • 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 including GDPR, fraud and abuse and anti-kickback statutes, OIG guidelines, industry codes in relevant markets including PhRMA, EFPIA and JPMA, US state marketing compliance laws, FCPA, UK Bribery Act and other anti-bribery laws.
  • Contribute positively to a strong culture of compliance and ethics.

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

  • Bachelor's degree required.
  • Minimum of 7 years of compliance experience in the pharmaceutical and life sciences industry preferred.
  • Experience in the areas of global compliance best practices, including working in markets outside the United States.
  • Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry.
  • Effective public speaking skills and an ability to communicate in both verbal and written form with multiple stakeholders within and outside the company.
  • Collaborative team player with ability to work effectively with cross functional teams and projects both within and outside of the Compliance function.
  • Strong problem solving, risk analysis, and project management skills.
  • Proficiency in Microsoft Office; experience in data analytics a plus.
  • Ability to effectively prioritize and work in a fast-paced environment and to handle multiple complex and confidential tasks.
  • Ability to travel domestically and internationally up to 25% of the year.

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.

 Apply here
Posted 1/16/2020

DIRECTOR, COMPLIANCE AUDITING & MONITORING - Jazz Pharmaceuticals
Location: Philadelphia, Pennsylvania
Country: United States
Category: Corporate
Type: Regular Full Time
Job ID: 4686

Overview:

Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.

Our therapeutic areas of focus include sleep and hematology/oncology - areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.

We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals.

Responsibilities:
The Director, Compliance Monitoring & Auditing is responsible for preparing and managing a small team to execute against the Jazz Pharmaceuticals, Inc. (Jazz) annual compliance monitoring plan. This position will oversee and assist with Compliance monitoring and auditing activities including: the monitoring of field activities, monitoring of company records and programs, executing and managing Jazz's annual Risk Assessment and Mitigation Process (RAMP) program, and managing remediation activities related to compliance findings and allegations of non-compliance with Company policy. The position will also be responsible for identifying and implementing leading-edge technology to further automate monitoring activities and implement innovative dashboards and analytics.

Primary Responsibilities:

  • Develops and manages the timely and accurate execution of the annual compliance monitoring plan.
  • Oversees and conducts live field monitoring of Commercial and Medical Affairs activities.
  • Oversees and conducts transactional monitoring of records and systems including but not limited to: patient assistance programs, arrangements and interactions with Independent Charity PAPs, expense reporting, medical information requests, and consulting and advisory engagements.
  • Prepares and presents reports and dashboards to numerous audiences, including the Compliance Committee that summarize monitoring and auditing findings and remediation.
  • Prepares reports for Certifying Employees under Jazz's Corporate Integrity Agreement that provide regular updates related to monitoring activities, metrics, trends, and/or observations within their area(s) of authority.
  • Incorporates monitoring and audit findings and observations into regular policy and SOP updates, Compliance training, and related Compliance communications.
  • Manages Jazz's annual RAMP process and prioritizing monitoring activities and mitigation plans based on potential risks associated with Jazz's products and with applicable Federal health care program requirements.
  • Develops and implements strategies to address and mitigate identified risks.
  • Manages the remediation and corrective action process within Compliance.
  • Conducts ad-hoc monitoring and auditing as necessitated by investigations and Jazz's Corporate Integrity Agreement.
  • Identifies and implements analytics and innovative technology to expand and advance monitoring and reporting capabilities.
  • Contributes as needed to the preparation of Government reporting, including reports required by the Corporate Integrity Agreement, Open Payments, and state law monitoring and reporting.
  • Develops and maintains updated knowledge and understanding of Jazz's products, industry regulations and guidelines, and Company policies and standard operating procedures.

Required Knowledge, Skills, and Experience:

  • Minimum of 8 years of healthcare compliance monitoring or auditing experience with a pharmaceutical/biopharmaceutical company or within the life sciences industry is required.
  • Demonstrated knowledge and understanding of the Anti-Kickback Statute and False Claims Act, Food and Drug Administration (FDA) rules and regulations regarding the promotion of pharmaceuticals, HIPAA, Open Payments, and relevant industry guidance, specifically PhRMA Code on Interactions with Healthcare Professionals is required.
  • Experience managing employees
  • Experience working under a Corporate Integrity Agreement is preferred.
  • Ability to manage multiple projects to completion on-time, meeting internal and external deliverables with high degree of accuracy.
  • Ability to interact with Jazz employees at all levels of the organization.
  • Team player with strong interpersonal skills.
  • Strong oral and written communication skills.
  • Ability to work collaboratively and independently as the circumstances require.
  • Self-motivated and detail-oriented.
  • Highest level of ethics and personal integrity.
  • Position may be based in Philadelphia, PA or Palo Alto, CA.

Required/Preferred Education:

  • Bachelor's degree required
  • Description of Physical Demands
  • Position requires regular travel within the United States (estimated at ~20% per year);
  • Participation in ride-alongs with field employees: one full day to multiple consecutive days;
  • Travel to participate at promotional programs: one hour to full day of attendance;
  • Travel to participate at external Conference, Congresses, and Industry events for 1-4 day periods;
  • Travel to Palo Alto office if needed to meet with business colleagues.

Description of Work Environment:

  • Work indoors will be in a normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes
  • Frequent computer use;
  • Responsibilities will require a work schedule that includes working outside of "normal" work hours while traveling in order to meet business demands;
  • Given the nature of work performed by the Compliance Department, the Director, Monitoring & Auditing may be asked to temporarily support other compliance related activities (e.g. CIA, compliance investigation(s), etc.) when necessary to meet a compliance obligation or firm [e.g. Government] deadline.

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

 Apply here
Posted 1/2/2020

ASSISTANT DIRECTOR ETHICS AND COMPLIANCE, RESEARCH AND INNOVATION - Astellas
Location: Northbrook, IL


Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.

There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.

Astellas is announcing an Assistant Director Ethics and Compliance, Research and Innovation opportunity in Northbrook, IL.

Purpose & Scope:
This position will provide compliance direction and support to Medical Affairs & Development (M&D), the departments supporting these functions and Astellas's global entities, affiliates and business partners. The individual will serve as a principle compliance resource for these clients, assist in the development and implementation of compliance strategies, tactics and materials, and will be responsible for providing direct support and advice to help clients adhere to the Company's highest ethics and compliance standards.

Essential Job Responsibilities:

  • Provide compliance support and serve as a resource to Medical Affairs & Development (M&D), the departments supporting these functions and Astellas' related entities, affiliates and business partners, with focus on compliance risk areas such as clinical research, scientific and medical publications, scientific meetings and other interactions and engagements with healthcare professionals (HCPs) and healthcare organizations (HCOs)
  • Proactively identify his/her clients' compliance needs and opportunities, respond to his/her client's compliance inquiries, provide timely and sound compliance advice and develop and implement solutions for meeting those needs and opportunities, collaborating where appropriate, with others within Ethics & Compliance.
  • Lead the compliance integration activities of new Astellas acquisitions to assimilate business practices and establish a culture of compliance
  • Conduct reviews and approvals of requests for meetings with HCPs and payments to HCPs and HCOs to ensure compliance, alignment and consistency with internal and external guidelines, policies and procedures.
  • Proactively identify client's compliance training and education needs, and participate in the development, implementation and delivery of innovative compliance training materials, communications, presentations, workshops and systems.
  • Conduct monitoring of Company events, programs and activities, such as interactions and meetings with HCPs, advisory boards, consultant meetings, symposium, Congresses, investigator meetings, and implement appropriate corrective action, where necessary.
  • Partner with Ethics & Compliance and Legal colleagues across regions to address issues and identify opportunities for collaboration, alignment, process improvement and best practice sharing.
  • Conduct needs assessments to identify compliance support needs and opportunities on a continuing basis, assist in identifying potential risk areas and assists in the development, execution and implementation of strategic and tactical plans to address identified risks and needs.
  • Contribute to the development and implementation of long-range strategic plans and initiatives to enhance compliance policies, processes and controls regionally and globally.
  • Collaborate with client management, Human Resources and Legal on compliance matters and investigations as appropriate to address specific compliance issues.
  • Other duties as assigned.

Quantitative Dimensions:

  • Establish a strong and visible compliance presence with the client's organizations.
  • Review materials and documentation related to engagements and meetings with HCPs and funding provided to HCOs
  • Conduct compliance training sessions for client groups/year
  • Conduct ongoing monitoring of documentation related to client activities, events and programs
  • Monitor live activities, events and programs/year

Organizational Context:
This position typically interacts with client employees through the President level globally, as well as those within other functions, such as Finance, Legal, Government Affairs and Human Resources.

Qualifications:

Required

  • BA/BS degree
  • 10+ years of related work experience
  • 5+ relevant pharmaceutical industry experience working within and/or directly supporting an R&D and Medical Affairs organization
  • Significant knowledge of and experience in industry compliance issues impacting R&D and Medical Affairs, both within the US and globally
  • Demonstrated team leadership skills and strategic focus required. Demonstrated ability to exercise independent judgment, effectively collaborate with multiple functional units, lead without authority, exercise tact and discretion in assessing compliance needs, and to respond timely and accurately to compliance inquiries.
  • Excellent oral and written communication, presentation, teaching and coaching skills required. Ability to effectively communicate compliance issues verbally and in writing in a clear and understandable manner. Demonstrated ability to inspire trust and confidence through effective communication and interpersonal skills.
  • Demonstrated ability to be proactive, identify and focus on critical priorities with little or no supervision, and manage multiple projects simultaneously.
  • Strong work ethic and ability to produce high quality work under deadline pressures.
  • Ability to travel within the US and internationally up to 25%

Preferred

  • Prior pharmaceutical compliance experience is preferred
  • Masters or other advanced degree preferred

 Apply here
Posted 12/27/2019

SENIOR MANAGER OF COMPLIANCE POSITION - UroGen Pharma, Inc.
Location: Princeton, NJ U.S.

Description
The Senior Manager of Compliance will report to UroGen's Associate General Counsel and will assist in the development, implementation and management of the company's compliance program with particular attention to the Sales, Marketing, Commercial, Market Access and Medical Affairs functions in the U.S.

Responsibilities:

  • Develop and deliver training and education to employees and contractors including the Sales, Marketing, Commercial, Market Access and Medical Affairs functions in accordance with industry standards and best practices
  • Develop and maintain a complete digital library of the company's compliance policies, procedures and training materials and records of training completion in accordance with industry standards and best practices
  • Develop and optimize a digital platform for the company's compliance training
  • Demonstrate a strong working knowledge of the federal and state laws, regulations, guidelines and industry standards that serve as the foundation for the company's compliance program, policies, procedures and training curricula
  • Guide and educate business partners on the company's compliance program, policies and procedures
  • Assist as needed with the management and upkeep of the company's compliance program including monitoring the compliance hotline, building internal awareness of the compliance function and whistleblower rights, building a culture of compliance, and developing compliance communications as needed
  • Assist with the development and execution of risk assessments and audit plans as needed
  • Prepare compliance reports and metrics as needed
  • Work on cross-functional teams as needed

Experience and Education:

  • 5+ years of compliance experience in the pharmaceutical/biotechnology industry
  • Substantial experience in the development and execution of compliance training and the overall management of compliance training in accordance with industry standards
  • Strong working knowledge of federal and state laws, regulations, guidelines and industry standards governing the pharmaceutical industry
  • Bachelor's degree required; M.S. or M.S.J. (Life Sciences Law) or equivalent preferred; J.D. attorneys will also be considered for the role
  • Certification in Healthcare Compliance or equivalent formal/rigorous training preferred

Skills and Training:

  • Experience with live training in individual, group and online settings
  • Shows interpersonal skills and the ability to communicate at all levels of fast-paced organization
  • Demonstrates ability to take initiative beyond direct responsibilities
  • Demonstrates professional and positive demeanor
  • Resolves conflicts in a constructive, professional manner
  • Works well on teams
  • Creative problem solver to support business goals
  • Well-organized, detail-oriented, and able to manage numerous projects and conflicting demands in a fast-paced environment
  • Shows high proficiency with computer systems and programs such as Microsoft Office, Word, Excel, PowerPoint, SharePoint, and DocuSign

Office Location:
400 Alexander Road, Princeton, NJ

Other
Occasional domestic travel required.

Interested applicants may apply on the UroGen website:  Apply here
Posted 12/24/2019

MANAGER, COMPLIANCE - Lundbeck
Location: Deerfield, Illinois, US

At Lundbeck, we are tirelessly dedicated to restoring brain health so every person can be their best. Headquartered in Copenhagen with a U.S. home office in Deerfield, Ill., Lundbeck is the only global pharmaceutical company focused solely on brain diseases. Our legacy in neuroscience goes back seven decades and we have a long heritage of innovation. Lundbeck has developed and commercialized some of the world's most widely prescribed therapies for psychiatric and neurological disorders. Today, we remain uncompromisingly committed to improving the quality of life for people impacted by brain disorders. Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep and productive pipeline, and we continue to bring forward symptomatic therapies to help people live better lives, while simultaneously pursuing disease-modifying treatments.

SUMMARY:
The Compliance Manager will have direct responsibility for and assist with the implementation of all elements of the Lundbeck North America 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.

ESSENTIAL FUNCTIONS:

  • Policies, Procedures and Controls, including Code of Conduct: Responsible for ongoing maintenance and updates to steering documents, policies and procedures. Partners 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. Partners 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.
  • Investigations: Conduct internal investigations relating to alleged compliance violations. Effectively manage all aspects of internal investigations, while ensuring legal compliance and managing risk. Partner with the Chief Compliance Officer (CCO) 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.
  • Assessments: Conduct assessments to determine effectiveness of Compliance trainings, education and other initiatives.
  • System Ownership: Serve as system owner for the electronic learning management system (LMS), compliance program management software, and electronic steering document management system (LuDo).
  • Third Party Management: Manage day to day vendor interactions including budget, SOWs, verifying vendor invoices, and processing for timely payment.
  • Advice, Guidance and Other Duties: Proactively provide day-to-day guidance to relevant business units on compliance matters. Help drive a compliant culture. Execute other duties as assigned by the CCO.

REQUIRED EDUCATION, EXPERIENCE and SKILLS:

  • Accredited Bachelor's degree.
  • 3+ years of Compliance-related experience in the pharmaceutical, biotech or medical device 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.

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 15% domestically. International travel may be required.

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.
 Apply here
Posted 12/13/2019

ASSOCIATE DIRECTOR CIA OPERATIONS - Astellas
Location: Northbrook, IL


Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.

There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.

Astellas is announcing an Associate Director CIA Operations opportunity in Northbrook, IL.

Purpose & Scope:
The Associate Director is responsible for the implementation and administration of a work plan and associated milestones for key E&C projects and Corporate Integrity Agreement (CIA) requirements. In addition, this role requires the comfort and experience of communicating with senior management and executives within the organization. This role requires familiarity with compliance operations, including development and implementation of policies, procedures, operational systems and monitoring platforms. This role encompasses the implementation of strategies, and the development and implementation of tools and resources to support a culture of high performance, and continual operational improvement.

Essential Job Responsibilities:

  • Work closely with external and internal business, legal and compliance stakeholders.
  • Help manage and correct potential risk areas, taking into account OIG guidance, industry trends, and past and planned business activities.
  • Responsible to manage large scale ongoing projects. Working collaboratively with team members and consultants to ensure that all project requirements, deadlines, and schedules are on track. Responsibilities include drafting project deliverables, status reports, and establishing effective project communication plans as well as the proper execution of said plans.
  • Knowledge in compliance with law, regulations and industry codes relevant to a highly regulated industry. Knowledge of best practices relating to compliance in highly regulated industries.
  • Manage corrective action plans to ensure that corrective action is appropriately documented, implemented and addressed.
  • Track observations across activities to identify compliance opportunities, including implementing additional controls, policies, processes, training or communication. Work with the business and others within the Compliance Department, as appropriate, to communicate and address observations and recommendations.
  • Build networks and relationships within the Compliance department and work collaboratively across other functional areas to build support for work plans and initiatives.
  • Stay current on compliance trends by researching industry publications and literature, benchmarking and consulting with industry counterparts and attending industry conferences and continuing education programs.
  • Other Ethics & Compliance initiatives deemed necessary to further enhance Astellas' commitment to ethics & compliance.

Quantitative Dimensions:
This position will manage concurrent initiatives across a variety of Astellas-sponsored commercial and non-commercial activities, and develop and maintain collaborative relationships with internal stakeholders across multiple Astellas business units to identify and mitigate potential risk to the Company.

Organizational Context:
Position reports to the Director, and typically interacts with employees across various Astellas functions, including without limitation, the Astellas Commercial, Medical Affairs and Research and Development organizations. Also collaborates with Legal and outside consultants.

Qualifications:

Required

  • BS /BA degree from an accredited college or university.
  • 7+ years of relevant management, monitoring, auditing, investigations or consulting experience
  • Relevant pharmaceutical industry experience.
  • Excellent written and verbal communication skills.
  • Strong analytical, organizational, problem solving, and follow-up skills. Ability to interpret rules and guidelines, and ability to conceptualize policies, procedures and controls.
  • Ability to prioritize and work simultaneously on multiple projects, strong attention to detail, and ability to organize and analyze complex information and data.
  • Demonstrated ability to handle confidential information with discretion and effectively collaborate with multiple functional units.
  • Demonstrated initiative and problem-solving skills, including the ability to proactively identify issues, anticipate needs and develop practical, meaningful solutions.
  • Ability to interact with colleagues with the appropriate respect and sensitivity.
  • Possesses a strong orientation to detail and the ability to work in a fast-paced environment.

Preferred

  • 5 years of project management experience
  • Expertise within the life science industry
  • Compliance program experience
  • CIA or Internal Review Organization (IRO) experience

 Apply here
Posted 11/20/2019

CLINICAL DEVELOPMENT COMPLIANCE MANAGER - AbbVie
Location: Lake County, IL USA


About AbbVie
AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world.

Job Description:
The Compliance Manager will be responsible for routine to moderately complex elements of AbbVie's compliance program related to Research & Development.

Key Responsibilities include:

  • Partners with all levels of key business functions to provide routine to moderately complex OEC and functional policy interpretation and provide guidance on the requirements.
  • Conducts compliance risk assessments, trend analyses and provides recommendations for compliant and best practice business activities.
  • Conducts routine to moderately complex policy and procedure reviews and updates related to OEC policy and functional procedures ensuring clarity, applicability and compliance.
  • Develops, delivers and updates OEC's comprehensive training program on routine to moderately complex OEC and functional policies and procedures, including the Operating Procedures for Program Funding and AbbVie's Code of Business Conduct, as well as the current compliance environment.
  • Possesses working knowledge of AbbVie's business, the current compliance environment and the broader business impact.
  • Participates in and may lead cross-functional OEC projects.
  • Provides guidance on proposed business strategies and programs, identifies routine to moderately complex legal and regulatory issues, analyzes alternatives and works with legal and other functions, as appropriate, to propose solutions to the business.
  • Develops, implements, modifies, and oversees corporate and/or functional monitoring plans and any corrective actions to ensure compliance with policies and procedures.
  • Assists OEC Associate Director on compliance audits, when necessary, such as overseeing the fulfillment of auditors' requests and acting as a liaison between the business and auditors during on site activities. Expected to evaluate and help respond to moderate to complex preliminary audit findings and recommendations, and to guide the business in preparing corrective action(s) to address routine to moderately complex findings and recommendations, and work with the business to ensure timely completion.

Qualifications:

  • Bachelor's Degree required. CPA, Master's, JD, or equivalent work experience preferred.
  • Experience in clinical development including areas of Fair Market Value (FMV)/payments, clinical compliance, contracting, clinical trials/protocols and GCP preferred.
  • Minimum of 4 years experience with, or exposure to, business functions such as clinical compliance, legal, regulatory affairs, government affairs, and finance.
  • Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
  • Learns, fast, grasps the 'essence' and can change the course quickly where indicated.
  • Raises the bar and is never satisfied with the status quo

Additional Information

  • Significant Work Activities and Conditions: N/A
  • Travel: Yes, 5 % of the Time
  • Job Type: Experienced
  • Schedule: Full-time

Equal Employment Opportunity Employer
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

 Apply here
Posted 11/15/2019

COMPLIANCE MANAGER, CORPORATE FUNCTIONS - AbbVie
Location: Lake County, IL USA


About AbbVie
AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world.

Job Description
Primary Job Function:

  • Provides timely and appropriate global compliance guidance for AbbVie business activities, including consultancies and contracting, grants and donations, sponsorship/exhibit/memberships, purchasing and finance.
  • Manages and tracks monitoring metrics/analytics, trends and observations for areas of responsibility. Develops and prepares periodic monitoring reports and presentations for leadership and/or stakeholder review. Closely collaborates with OEC Business, Training, Monitoring, and Brand support to ensure monitoring results are reviewed and corrective action(s), if necessary, are implemented.
  • Identifies, implements and manages systems, processes and applications to maintain or improve efficiency and effectiveness for areas of responsibility.
  • Works with Director of Transparency and AbbVie Legal to assess and interpret federal and state regulations, evaluate options and proposes solutions that includes monitoring compliance with specific state and federal reporting requirements.
  • Reviews and provides guidance on global potential conflicts of interest.
  • Serves as a resource and subject matter expert on various global policies and procedures.
  • Provides compliance support for and participates as a member of various AbbVie committees and councils.
  • Other special projects & responsibilities, as assigned.

Core Job Responsibilities:

  • Finds opportunities for improvement in AbbVie's business activities and processes and proactively drives and monitors implementation efforts.
  • Handles multiple projects simultaneously.
  • A high level of interpersonal skill is critical to the successful performance of this position. This involves creativity, originality and judgment as well as tact, diplomacy and the ability to instill confidence. Candidates should have the demonstrated ability to communicate effectively, present professionally, and work well with various levels within the organization.

Position Accountability / Scope:

  • Reports to OEC Associate Director.
  • Operates independently within well-defined expectations, checking in as necessary with supervisor(s).
  • Provides guidance and direction to all levels of the business as well as OEC personnel related to monitoring activities/results, as needed.
  • 5% travel

Basic:

  • BA/BS or equivalent work experience required.
  • 6+ years' experience with, or exposure to, business functions such as compliance, audit, legal, medical or regulatory affairs or finance.
  • Demonstrated strong communication skills, both written and verbal.
  • Previous pharmaceutical experience preferred.

Additional Information:

  • Significant Work Activities and Conditions: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
  • Travel: Yes, 5 % of the Time
  • Job Type: Experienced
  • Schedule: Full-time

Equal Employment Opportunity Employer
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

 Apply here
Posted 11/15/2019

ASSOCIATE DIRECTOR, COMPLIANCE - AbbVie
Location: Lake County, IL USA


About AbbVie
AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world.

Job Description:
The Associate Director, Compliance possesses working knowledge of AbbVie's business, the current compliance environment and the broader business impact of compliance issues to develop and provide solution-oriented compliance guidance related to AbbVie's compliance program for the company's oncology therapeutic area.

Key Job Responsibilities:

The Associate Director, Compliance may perform the following with limited supervision from the Compliance Director, Oncology:

  • Serves as the compliance lead for at least one oncology brand team.
  • Partners with all levels of key business functions to provide Office of Ethics and Compliance (OEC) and functional policy interpretation and guidance on compliance requirements.
  • Conducts compliance risk assessments, trend analyses and provides solutions and recommendations for compliant business activities.
  • Provides guidance on proposed complex business strategies and programs, identifies legal and regulatory issues, analyzes alternatives and partners with other functions, as appropriate, to propose compliant business solutions
  • Leads cross-functional OEC programs and collaborates regularly with OEC colleagues to resolve issues and share learnings.

Key Leadership Competencies:

  • Builds strong relationships with peers and cross-functional partners outside of the team to enable higher performance
  • Learns fast, grasps the "essence" of issues and can change course quickly where indicated
  • Raises the bar and is never satisfied with the status quo
  • Deals comfortably with risk and ambiguity, makes high-quality decisions with less than perfect information
  • Manages conflict and difficult conversations across all levels of employees in a constructive, transparent way

Minimum Qualifications:

  • BA/BS required. JD, PharmD, MD, DO, RN and/or MBA encouraged.
  • Experience within pharmaceutical industry is preferred.
  • A minimum of 6 years' experience required with exposure to business functions such as compliance, legal, regulatory affairs, medical affairs and/or commercial.

Additional Information

  • Significant Work Activities and Conditions: N/A
  • Travel: Yes, 5 % of the Time
  • Job Type: Experienced
  • Schedule: Full-time

Equal Employment Opportunity Employer
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

 Apply here
Posted 11/15/2019

COMPLIANCE ANALYST - Karyopharm Therapeutics
Location: Newton, MA US
Job ID: 2019-1445
#of Openings: 1
Category: General & Administrative
Type: Regular Full-Time


Responsibilities
Karyopharm Therapeutics is looking for a high energy, detail-oriented candidate to join our Compliance team. The Compliance Analyst will be responsible for serving as the Executive Assistant to the Chief Compliance Officer and will provide supplemental coordination and support to other members of the Compliance and Legal team as required. Additionally, the Compliance analyst will support key Compliance initiatives and business processes including, but not limited to: tracking training assignments, creating and updating compliance dashboards, updating policies, developing training materials, event planning, transparency reporting, compliance campaigns and communications. The Compliance Analyst will be an integral part of the Compliance Team and will have an opportunity to attend/facilitate key meetings, work cross functionally, and attend conferences and seminars to enhance substantive expertise. This position will report to the Chief Compliance Officer, and will be located at our headquarters in Newton, MA.

Role Responsibilities:
The successful candidate will be highly experienced Executive Assistant who is ready for the opportunity to gain substantive compliance experience.

  • Supporting the development of training and meeting presentations
  • Creating and updating compliance dashboards
  • Managing compliance communications and newsletters
  • Developing systems and processes to track Compliance training
  • Completing expense reports and travel arrangements
  • Calendar Management
  • Preparing minutes and other documents for key meetings.
  • Working cross functionally to plan events and major meetings
  • Other tasks as assigned.

Qualifications:

  • Bachelor's Degree required.
  • Minimum of 5 years in an Executive Assistant role required
  • Expert Level Power-Point skills required
  • Strong General Computer Skills and common health care business systems (Word, Excel, SAP, Concur, Adobe Software) required
  • Excellent written and verbal communication skills required.
  • Pharmaceutical, Biotech or Medical Device industry experience preferred
  • Demonstrated resilience and ability to problem solve independently
  • Strong teamwork, collaboration and sense of urgency

Overview
Karyopharm Therapeutics is a global commercial-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.

Karyopharm Therapeutics Inc. (the "Company") is an equal opportunity employer. All qualified applicants will be considered without regard to age, race, color, sex, religion/creed, national origin, marital status, ancestry, citizenship, military, reservist or veteran status, pregnancy, sexual orientation or preference, gender identity, gender expression, physical or mental disability, genetic predisposition or carrier status, or any other category protected under applicable federal, state or local law. Consistent with its obligations under applicable law, the Company will make reasonable accommodations for qualified individuals with disabilities. If you require an accommodation in the application process, please contact a member of the Company's Human Resources department.

 Apply here
Posted 11/12/2019

SENIOR MANAGER, ETHICS & COMPLIANCE MONITORING - Astellas
Location: Northbrook, IL


Astellas is announcing a Senior Manager, Ethics & Compliance Monitoring opportunity in Northbrook, IL.

Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.

There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.

Purpose & Scope:

The position plays a key role in Ethics & Compliance in support of the following:

  • The development, enhancement, and execution of risk-based compliance monitoring programs across a variety of Astellas-sponsored commercial and non-commercial live and transactional activities.
  • Planning and conducting risk assessments; executing data analytics; assisting the business with self-monitoring, assisting and/or preparing required presentations/reporting; conducting root cause analyses; developing and implementing strategies to address and mitigate identified risks.
  • Serving as a resource to support the development and enhancement of compliance monitoring programs in other Astellas affiliates.
  • Demonstrating good judgment and following organizational and professional ethical standards.

Essential Job Responsibilities:

  • Responsible for timely and accurate execution of risk-based compliance monitoring programs (live and transactional) across a variety of Astellas business activities, including activities conducted by the Astellas Commercial, Medical Affairs, and Research and Development organizations.
  • Under minimal supervision, develops and enhances testing criteria, ensures selection of appropriate monitoring samples, collects and analyzes relevant documentation, develops and documents monitoring observations, ensures the preparation and maintenance of appropriate monitoring workpapers, reporting and related documentation and communicates findings.
  • Executes, documents and reports on the risk mitigation activities, including developing and/or maintaining monitoring dashboards, issue tracking mechanisms, and related reporting tools.
  • Manages and tracks monitoring metrics, trends and observations. Develops and prepares periodic monitoring reports/presentations as necessary for E&C and business leadership, the US Compliance Committee, and other relevant stakeholders as appropriate.
  • Assists with the development and implementation of monitoring and remediation activities to enhance the overall efficiency and effectiveness of the compliance monitoring program and/or to meet regulatory and/or business requirements. This includes, but is not limited to, developing, enhancing and implementing monitoring activities (including expanded data analytic monitoring capabilities) as well as policies, procedures and processes.
  • Identifies, implements and manages systems/applications, solutions and other resources to enhance and maintain overall efficiency and effectiveness of the compliance monitoring program.
  • Assists in the training, development, management and oversight of compliance monitoring co-source partners.
  • Conducts risk assessments to identify, evaluate and prioritize the Company's potential risk areas, taking into account prior monitoring observations, identified and emerging risk areas, OIG guidance, industry trends, and past and planned business activities. Interviews business leaders and partners with internal stakeholders, including Internal Audit and Quality Assurance, to ensure communication and collaboration of auditing and monitoring plans.
  • Ensures that monitoring findings, observations and trends, as appropriate, are integrated into compliance and business policies, processes, training and communications to most effectively mitigate risk.
  • Serves as a monitoring resource to support the development, implementation and enhancement of E&C monitoring programs in other Astellas affiliates.

Quantitative Dimensions:

This position will evaluate and contribute to the improvement of business processes across a variety of Astellas commercial and non-commercial business activities through the development, execution and oversight of risk-based compliance monitoring programs. It will also assist in supporting Astellas with risk assessment and mitigation processes pertaining to the Corporate Integrity Agreement.

Organizational Context:

Position reports to the Director, Monitoring & Risk Mitigation who reports to the Executive Director, Healthcare Compliance & Risk Mitigation. Position works with all company functional/operational areas and employee levels in gathering, evaluating, and communicating information about the activity or processes being reviewed. This position will collaborate with various groups both within and outside of E&C

Qualifications:

Required:

  • BS /BA degree from an accredited college or university.
  • 7 + years of full-time experience in auditing and/or compliance monitoring.
  • Advanced level Excel skills (e.g., sumif, vlookup, hlookup, rank, count if, if statements, etc to be able to properly manipulate and report data).
  • Minimum of 3 years of relevant pharmaceutical/healthcare industry experience in a compliance, internal audit, or business consulting role.
  • Knowledge of pharmaceutical industry laws and regulations and related compliance issues.
  • Possesses a natural curiosity, strong orientation to detail and the ability to work in a fast-paced environment.
  • Demonstrated project management skills and the ability to work on multiple projects simultaneously with little supervision under tight deadlines.
  • Demonstrated initiative and problem-solving skills, including the ability to proactively identify issues and develop practical, meaningful solutions.
  • Demonstrated ability to exercise independent judgment, objectivity, handle confidential information with discretion and effectively collaborate with multiple functional units.
  • Demonstrated ability to interact with and present information to colleagues with the appropriate respect and sensitivity.

Preferred:

  • Prior supervisory experience.
  • Developed and/or assisted in the development/implementation of a compliance monitoring program within the pharmaceutical industry.
  • Professional / advanced degree or certification such as a MBA, JD or CPA.
  • Prior experience using a data analytics tool (e.g., Qlikview, Tableau).

 Apply here
Posted 10/24/2019

CORPORATE COMPLIANCE OPERATIONS SPECIALIST - Spark Therapeutics
Location: Philadelphia, PA, US
Date: Oct 3, 2019

Join the Spark Team

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.

We don't follow footsteps. We create the path.

Summary:
The Corporate Compliance Operations Specialist will analyze Healthcare Professional (HCP) and Healthcare organization (HCO) spend data and Compliance Monitoring assessments, policy and procedure development, and provide functional and technical support for Learning Management System (LMS), Aggregate Spend, and Monitoring software.

Responsibilities

25% Aggregate Spend and Transparency analysis:

  • Analyze HCP and HCO spend data from internal and external sources to ensure compliance with applicable federal and state reporting requirements and company policies
  • Analyze and reconcile individual payments or transfers of value to HCPs and HCOs to confirm data is complete, accurate and consistent, including review of Concur, Accounts Payable and third-party vendor data
  • Manage weekly remediation of payment data
  • Support testing and implementation of Aggregate Spend enhancements to various systems (e.g., CRM, accounts payable, purchase order systems)
20% Monitoring and Auditing analysis:

  • Analyze data from Monitoring tool to summarize observations and offer recommendations for monitoring plans and remediation
  • Analyze data from various sources (e.g., CRM, Concur, Aggregate Spend, Veeva) to aid Compliance and Internal Audit reviews and assessments of policy adherence
  • Conduct transaction auditing
  • Conduct live monitoring
  • Maintain and modify monitoring templates and checklists
20% Learning Management System:

  • Manage LMS assignments, updates, testing, and process improvements
  • Analyze and ensure data integrity including quality, accuracy, and functionality of training modules and system interfaces
  • Co-develop, review content and test new trainings for Compliance and other departments
  • Create guidelines and business process documentation
  • Recommend curricula improvements
20% Corporate Compliance Policies and Procedures:

  • Draft policies and procedures with input from SMEs
  • Coordinate review and approval of policies
  • Develop training solutions with vendors
  • Track and measure employee training on all Compliance policies
15% Background Screening, Fair Market Value administration, and other Compliance projects:

  • Conduct background screening for HCP services to Spark
  • Advise internal stakeholders with FMV calculations related to HCP services
  • Manage content for Compliance SparkSpace and SharePoint sites
  • Responsible for quarterly budget accruals
  • Maintain policy index and definitions including maintenance of documentation Compliance and company shared sites

Requirements:

  • Bachelor's degree required, advanced degree preferred.
  • Healthcare Compliance Certification a plus.
  • 8 - 10 years of experience in the biotech/biopharma/pharma industry with progressively responsible roles in analytics and customer management. Competencies
  • Excellent written and verbal communication skills; excellent public speaking/presentation skills and experience with creating analytical assessments in Microsoft PowerPoint® or other presentation formats. Proficiency in Microsoft Access® and Microsoft Excel®
  • Demonstrated analytical and problem-solving skills
  • Strong background with numerous industry standard and proprietary software solutions
  • Ability to work in a dynamic, fast-paced environment with shifting priorities
  • Working knowledge of, or ability to quickly become conversant with, various laws, regulations and industry guidance that affect Spark's Corporate Compliance Program (e.g., OIG Compliance Program Guidance for Pharmaceutical Manufacturers, PhRMA Code on Interactions with Healthcare Providers, industry guidance documents, CIA trends, regulations regarding the promotion of marketed products, Open Payments EFPIA and the False Claims Act and Anti-Kickback Statutes)

 Apply here
Posted 10/17/2019

HEALTHCARE COMPLIANCE MANAGER / SENIOR SPECIALIST - Puma Biotechnology Inc.
Location: South San Francisco, CA

Permanent position in South San Francisco for a passionate pharmaceutical healthcare compliance professional who will have a critical role in development and building of a comprehensive and effective compliance program. This position reports to Director, Healthcare Compliance.

Summary/Objective
The Compliance Manager/Senior Specialist provides support for all elements of the comprehensive compliance program including conducting trainings and providing guidance to various teams, monitoring activities with significant risk, conducting investigations, reviewing needs assessment as well as partnering with business to ensure that all HCP transparency requirements are met. This role will support efforts to enhance compliance culture.


Essential Functions:

  • Support the implementation of the comprehensive compliance program under the direction of the Compliance Director.
  • Partner closely with various teams including Commercial, Field Employees, Sales Operations, Market Access and Medical Affairs and serve as a point of contact for compliance related questions.
  • Has an active role in the drafting, implementation and communication of Compliance-related policies and procedures.
  • Conduct compliance training, either in-person or online, on variety of compliance topics during New Hire Orientation, sales meeting, and any other supplemental training according to particular business need.
  • Assists in conducting compliance risk assessments as well as developing and supporting implementation of mitigation plans.
  • Supports compliance monitoring and audit efforts, conducts field monitoring, review data, draft reports and identify corrective actions.
  • Assists in investigations to the extent requested, including conducting reviews of documentation, conducting interviews and drafting reports
  • Monitor interactions with and payments to healthcare professionals. Work with various business partners and third party vendors to ensure HCP spend transparency reporting obligations are met on time.

Competencies:

  • Sound judgment, and strong commitment to ethical conduct and integrity.
  • Excellent interpersonal skills, able to work across different functions
  • Attention to detail, proficiency in Excel and ability to work with data
  • Good communicator, able to communicate in one on one or group setting.
  • Able to draft clear and effective reports, policies etc.
  • Project management skills. Ability to follow through and complete tasks on time with minimal supervision.

Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Required Education & Experience
Education:

  • Bachelor Degree or an Associate's Degree with relevant work experience

Experience:

  • Four to six years of experience related to implementing a compliance program with-in a business, or other complementary job experience (such as roles within Internal Audit, Finance or Legal functions).
  • Comprehensive working knowledge of applicable laws and industry guidance relating to healthcare and life science, and familiarity with the current life science marketplace

Additional Eligibility Qualifications:
Preferred Special Training:

  • Certification in healthcare compliance or auditing

Position Type/Expected Hours of Work
This is a full-time position. Days and hours of work are Monday through Friday, 8:30 a.m. to 5 p.m. This position may require some overtime work.

Work Environment
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Physical Demands
The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.

The physical demands of the office are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; and talk or hear. The employee must occasionally lift or move up to 25 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.

Travel
Travel is primarily local during the business day, although some out-of-area and overnight travel may be expected. Travel may be required (up to 15 %).

Equal Opportunity Employer
Our client is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, ethnicity, age, disability, veteran status, marital status, or any other characteristic protected by law.

 Apply here
Posted 10/16/2019