The Pharmaceutical Compliance Forum

Employment

POST A POSITION
For information about placing your employment listing on this page, email:
info@pharmacomplianceforum.org.
Cost is complimentary for PCF Members and $600 for 90 days for non members.

EMPLOYMENT OPPORTUNITIES


 

DIRECTOR/COMPLIANCE COUNSEL - Heron Therapeutics

JOB DESCRIPTION:
This position supports the compliance function and will be responsible for assisting in the development, execution and continuous improvement of the compliance program to ensure compliance with all applicable standards, laws, and regulations, including without limitation the U.S. Anti-Kickback Statutes, the False Claims Act, the Stark Laws, the Sunshine Act (Open Payments), the FCPA and HIPAA. This position will support the Chief Compliance Officer with respect to commercial legal and compliance matters and activities as well as other Legal projects as needed.

ESSENTIAL DUTIES & RESPONSIBILITIES:

  • Monitors activity to help ensure compliance with PhRMA Code with respect to HCP interactions
  • Provide advice and training to employees of the Company on the health care compliance program using a solid understanding of U.S. pharmaceutical laws, including regulatory and compliance issues and laws pertaining to interactions with healthcare providers
  • Provide legal support for wide range of commercial and medical affairs activities related to product launch and ongoing promotion of pharmaceutical products
  • Provide legal guidance to Promotional Review Committee
  • Provide legal guidance to Medical Review Committee
  • Provide legal guidance to Grants Committee
  • Stay current on applicable law, regulation, and practice and communicating senior management apprised of current developments

REQUIREMENTS:

  • Minimum of 3-5 years relevant commercial compliance experience, including prior in-house experience with a biotech/pharmaceutical company
  • BA/BS degree and JD required
  • A solid understanding of U.S. pharmaceutical laws, including regulatory and compliance issues
  • A solid understanding of laws pertaining to interactions with healthcare providers (Anti-Kickback, False Claims etc.)
  • Ability to handle highly confidential and sensitive materials and information with complete discretion
  • Ability to provide commercial contracting support also strongly preferred
  • Ability to work with external counsel, vendors and business partners
  • Ability to work within a very small legal/compliance department, and establish and maintain relationships across multiple corporate functions
  • Adaptable and flexible, able to prioritize duties and manage multiple matters from start to finish with minimal supervision
  • Exceptional attention to detail and excellent organizational skills and the ability to work on a variety of tasks and projects simultaneously with minimal supervision.
  • Ability to work cooperatively and collaboratively with all functions and levels of the Company
  • Proven ability to communicate effectively in a variety of difficult and sensitive situations
  • Ability to thrive in a dynamic and past-paced environment
  • Able and willing to work from our Jersey City, NJ Office

EOE

The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.

Interested applicants should send their resumes to the following email address jobs@herontx.com.
Posted 10/16/2017


 

MANAGER/SENIOR MANAGER COMPLIANCE GENERALIST - United Therapeutics Corporation

The Manager/Senior Manager Compliance Generalist owns various tactical operations and full project management of various initiatives and systems within the compliance program. This includes internal company-wide communications; assisting with monitoring and auditing aligned with strategic plans, and creating reports for internal and external business partners to implement effective compliance controls.

Key Accountabilities / Responsibilities:

  • Facilitate activities to complete deliverables within timelines, using judgment to troubleshoot and/or escalate issues to VP Compliance as necessary
  • Manage and prioritize multiple complex projects; collaborating with multi-functional subject matter experts and stakeholders as required
  • Prepare and provide reports, presentations, materials, guidelines, and documents in response to internal and external inquiries
  • Create tracking tools and provide accurate tracking reports related to project management initiatives, as well as external government inquiries and corporate integrity agreement requirements
  • Support compliance monitoring and auditing initiatives via live and backend activities
  • Assist with federal/state aggregate spend activities via accurate analysis and output of reportable spend under guidance of Senior Director
  • Assess fair market value of various activities, including but not limited to: Commercial, Medical Affairs, and Clinical Research
  • Create and maintain Compliance intranet site
  • Draft company-wide communications related to Compliance Program initiatives or enhancements
  • Assist with creation or revision of Corporate Compliance policies and procedures
  • Assist with the evaluation and creation of internal training materials, including working with third party training vendors to create such materials
  • Maintain current knowledge of changes, trends, rules, regulations, and industry guidance impacting pharmaceutical commercial activities; including FDA regulations, OIG guidance, and the PhRMA Code
  • Develop and demonstrate knowledge and competency to serve as a compliance and ethics subject matter expert
  • Perform other duties as assigned

Minimum Requirements:

  • Bachelor's degree in Business, Finance, Life Sciences or healthcare related field
  • 7 years of experience in the biopharmaceutical industry, including 5 years in a compliance role
  • Proficiency with MS Office suite, and with databases to track report, and present monitoring and auditing data
  • Strong knowledge of and ability to function within corporate integrity agreement environment to meet needed requirements
  • Ability to travel as needed up to 40%

Preferred Knowledge, Skills, and Abilities:

  • Healthcare or Corporate Compliance Certification program; PMI/Lean Six Sigma preferred
  • Organized and detail-oriented with excellent communication skills
  • Solid knowledge of compliance program structures within the biopharmaceutical industry in accordance with OIG guidelines, PhRMA and FDA legal requirements, healthcare compliance law, and related regulations
  • Strong project management experience with ability to work independently, act with urgency and high motivation, and interact with personnel at all levels and across all functions

United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities

  Apply here
Posted 9/22/2017


 

DIRECTOR/SENIOR DIRECTOR OF COMPLIANCE MONITORING, AUDITING, AND INVESTIGATIONS - United Therapeutics Corporation


Position Overview
As the Director/Senior Director of Compliance Monitoring, Auditing, and Investigations you will oversee the development and execution of all monitoring and auditing activities, including conducting the annual risk assessment. Additionally, you will be responsible for the investigations process, database/hotline, and timelines, as well as the third party due diligence process.

Key Accountabilities / Responsibilities:

  • Conduct annual risk assessment to develop the auditing and monitoring plans, making adaptions consistent with dynamic business risks as needed
  • Conduct monitoring of Sales, Marketing, Medical Affairs, and R&D activities from a corporate compliance perspective; identifying potential areas of vulnerability and risk, and providing guidance on handling and avoiding such situations
  • Develop and implement corrective action plans in partnership with functional leadership for resolution of problem areas or gaps
  • Manage live and online auditing and monitoring, including metrics and meaningful reporting for committee meetings. Strategically select auditing and monitoring samples and identify trends and potential risks as necessary
  • Recognize and respond to compliance issues in a timely manner; following up to resolve and improve processes
  • Own and continually improve due diligence process, including related government documents and relevant system and cross-functional alignment
  • Manage all investigations and related processes, collaborating with relevant members of management, legal, HR, and other departments to ensure appropriate outcomes, and serving as a touchpoint for investigations committee members
  • Perform other departmental duties as assigned

Minimum Requirements:

  • Bachelor’s degree in Business, Finance, Life Sciences or another healthcare-related field
  • 10+ years in pharmaceutical/biotechnology industry
  • 7+ years in Audit/Corporate Compliance roles
  • Knowledge of regulatory/compliance requirements (anti-kickback statute, False Claims Act, FCPA, Sunshine Act)
  • Ability to detect and present trends/patterns in auditing, monitoring, and investigations findings
  • Experience developing, deploying, and maintaining compliance program policies
  • Proficiency in Microsoft Office with Advanced Excel, PowerPoint, and database skills
  • Ability to travel as needed up to 40%

Preferred Knowledge, Skills, and Abilities:

  • Master's degree or Juris Doctorate preferred
  • Organized and detail-oriented with excellent communication skills
  • Ability to build relationships with internal customers
  • Success in operating under a corporate integrity agreement by meeting all government reporting requirements while balancing with business continuity
  • Ability to act with urgency and high motivation, taking initiative and following up to complete projects professionally and timely

United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities

  Apply here
Posted 9/22/2017


 

SENIOR MANAGER COMPLIANCE (167544) - Allergan plc
HM: Timothy Roberts

Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world.

Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.

Our success is powered by our world-class team's commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.

Join one of the world's fastest growing pharmaceutical companies!

At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn't just welcomed, it's encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.

Position Description
Under limited direction, the Senior Manager partners with the US Commercial organization and others within the Compliance organization to understand business priorities and provide compliance support on strategy, tactics and operations. This position is responsible for the evaluation of Commercial programs / activities and helping to design and deliver innovative solutions that support the vision, values and corporate goals of the Company, and provides guidance to help achieve goals while mitigating risk to the assigned organizations. Also ensures harmony across the US organization as a member of a broader US Commercial Compliance Team.

Primary Job Responsibilities: Within assigned commercial business units, the position responsibilities include providing compliance support related to various business activities, with a primary focus on interactions with healthcare professionals for training and consultative activities as well as effective execution of selling and marketing initiatives. Examples include, but are not limited to, routine interactions with healthcare professionals, planning and execution of various healthcare professional engagements and professional educational activities, cross-functional collaboration initiatives, as well the development and delivery of compliance training at meetings and events. Responsible for providing support to Monitoring and Investigations as needed. Assists Compliance leadership with strategic initiatives within US Commercial Compliance to ensure adherence to internal policies and procedures and federal and state requirements.

Core Competencies:

  • Collaboration: Partner with multiple internal and external stakeholders in the development of strategic initiatives related to business goals
  • Training: Train business partners on compliance guidelines, policies and best practices related their specific business.
  • Guidance: Provide regular guidance to the business regarding the Global Compliance Program
  • Reporting: Provide strategic insights to business partners based on compliance data analysis
  • Problem Solving: Provide innovative solutions to mitigate risk while supporting business goals and objectives
  • Business Knowledge: Develop a comprehensive understanding of the products, initiatives and goals of the business.

Essential Job Functions:

  • Provide timely and practical advice and support for questions and concerns regarding compliant activities
  • Provide strategic and tactical support of key business operations functions and Centers of Excellence
  • Partner with members from Sales, Marketing, Legal, Business Operations, HR and Medical Affairs departments for compliance-related activities.
  • Develop and deliver regular and ongoing training and education to the Commercial organization
  • Provide data analytics and reporting related to monitoring findings and other compliance observations to internal stakeholders as well as external regulators
  • Assist and provide input to compliance audits, monitoring and internal investigations as needed

Required Knowledge:
Awareness of federal fraud and abuse laws and guidance, including the ACCME guidelines, the Office of Inspector General reports, and the Food, Drug and Cosmetic Act and an understanding of the roles and authority of government agencies and industry partners including FDA, OIG, PhRMA and AdvaMed.

Positions Qualifications:

  • Bachelor's degree required; advanced degree preferred
  • 5-7 years of experience in Compliance, with 2-3 years of experience in the pharmaceutical or medical device industry preferred
  • Prior experience in business/customer facing role required
  • Prior experience managing projects.

  Apply here
Posted 9/11/2017


 

MANAGER COMPLIANCE INVESTIGATIONS (Req 167545) - Allergan plc
HM: Carol Sweeney

Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world.

Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.

Our success is powered by our world-class team's commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.

Join one of the world's fastest growing pharmaceutical companies!

At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn't just welcomed, it's encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.

Position Description
The Manager, Compliance Investigations, will support the Global Investigations function and the HealthCare Compliance Audit team and report directly to the Associate Director, Compliance Investigations.

The Manager's responsibilities include conducting and/or supervising complex activities associated with the implementation and maintenance of various audit and investigation processes and various other corporate programs. In addition, this position will assist with the management of various projects based on the needs of the Compliance Department.

  1. Demonstrate enterprise-wide lateral leadership when conducting compliance investigations involving potential violations of local, state, and federal laws, violations of company policy/procedure and/or company global Code of Conduct.
  2. Analyze data and supporting documentation to assess the validity of compliance allegations, and aggregate results to provide strategic insight into allegation trends.
  3. Conduct interviews of the reporter, and others to gather facts and obtain statements regarding the allegation(s).
  4. Manage entries to Disclosure Log and Potential Issue Investigation information for CIA.
  5. Provide regular reports including investigation outcomes, status updates and recommendations to Compliance Leadership team and Disciplinary Review Committee.
  6. Maintains strict professional, ethical, legal adherence and confidentiality at all times.
  7. Provide updates and reports on a regular basis to the Associate Director, Compliance Investigations, and as requested to the Global Chief Compliance Officer, on the operation and progress of investigation outcomes, and project status updates.
  8. Provide investigative support to other business functions as needed.

Education:
Bachelor's Degree required, advanced degree a plus.

Experience:
4 -6 years of professional experience in the areas of internal and/or external audit/investigation/monitoring in a pharmaceutical and life sciences industry.

Licensure/Credentials:
Compliance and fraud related certifications a plus (e.g. CCEP, CFA, CPA)

  Apply here
Posted 9/11/2017


 

ASSOCIATE DIRECTOR COMPLIANCE TRAINING (167546) - Allergan plc

Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world.

Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.

Our success is powered by our world-class team's commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.

Join one of the world's fastest growing pharmaceutical companies!

At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn't just welcomed, it's encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.

Position Description
The Associate Director's responsibilities include supporting the Company's Corporate Compliance function with special emphasis and focus on leading Compliance training initiatives. Additionally, this position will support Compliance related policies and procedures, and Compliance communications. This position will also serve as a liaison to internal and external business partners, providing direction and guidance related to Allergan's Compliance program. This position requires an individual with strong capabilities in creating and executing training programs globally using various delivery tools and current adult learning methods for our multi-generational and multi-cultural nature of colleagues.

  1. Support leadership team in making recommendations on enterprise wide Compliance programs, including training adherence and effectiveness.
  2. Develop and execute the global training strategy for compliance related topics using innovative techniques to increase the understanding and application of the core values of our company.
  3. Apply appropriate training techniques across multiple platforms to engage colleagues in an effective and efficient manner.
  4. Inspire others to follow the established direction for the organization. Identify areas of opportunity to enhance compliance through effective training programs and communication.
  5. Identify, deliver and present issues to management with proactive recommendations on addressing the issues
  6. Provide regular updates and reports to management on Compliance projects and training initiatives.
  7. Integrate compliance controls into the scope of existing business practices company-wide
  8. Maintain corporate compliance policies that are clear, concise and values based.
  9. Serve as subject matter expert to internal and external stakeholders for a variety of compliance functions, including policies and training content and systems
  10. Support specific critical special projects that are aimed at increasing compliance while simplifying business processes.
  11. Oversight of relationships with third party vendors and business partners to help ensure adherence to our Compliance program
  12. Maintain strict ethical, legal adherence and confidentiality at all times

Education:
Bachelor's degree is required, advanced degree a plus.

Experience:
Minimum 8-10 years Corporate Compliance in the pharmaceutical and life sciences industry, or similar transferable experience. Three or more years of experience related to adult learning in a corporate environment. Experience in field sales, marketing or regulatory/legal also a plus.

  Apply here
Posted 9/11/2017


 

COMPLIANCE OPERATIONS ASSOCIATE DIRECTOR - EXELIXIS
Location: SSF
Salary Grade: 11
Division: G&A
Job Code: TBD
Department: 10015 Compliance
FLSA Status: X Exempt
Reports To: VP, Compliance
Effective Date: September 2017


SUMMARY:
The Compliance Operations Associate Director will be responsible for leading the development, implementation, and continuous improvement of healthcare compliance practices, systems, and processes, with an emphasis on business integrity, operational excellence, and practicality. One primary focus will be overseeing and enhancing the Company's healthcare compliance audit and monitoring program and establishing the strategy and infrastructure needed to enable the company to track and evaluate compliance of its ongoing activities. To that end, this position will be responsible for evaluation of materials submitted for review and approval, performing audits of and monitoring of interactions with the healthcare community, and facilitating internal reporting. Of similar priority will be management of the process for tracking and reporting HCP spend. Furthermore, this position will be responsible for supporting governance committee meetings. The essential business partners for this function are corresponding positions in Sales, Marketing, Medical Affairs, HR, IT, and Finance.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Works on a range of departmental and/or strategic problems where analysis of situations or data requires critical thinking, an in-depth evaluation, and company knowledge of various factors. May also be required to manage external consultant engagements, when needed, including overall budgets, schedules, and performance standards.
  • Responsible for overseeing the successful implementation and execution of the audit and monitoring program, including development of tools, performance standards, and completion of corrective action. In taking ownership of the program, the team lead will need to be strategic partner with Commercial, Medical Affairs, and Development to ensure that the program evolves as the company grows.
  • Leads the ongoing fulfillment of the company's HCP spend tracking and reporting obligations under the ACA's Sunshine Act provisions and related state laws regulating HCP spend by drug manufacturers or requiring state tracking and reporting. Applies advanced technical expertise in this arena and supports goals with an understanding of priority and impact to the program, department and organization.
  • Acts as a consultant, reviewer and legal/compliance approver as needed, for business activities that involve Healthcare Compliance risks, and contributes to departmental process and organizational improvements and development, including management of the contract request process for HCP engagements. In addition, participates in reviews of requests for approval of advisory board meetings, speaker programs, and other Commercial, Medical Affairs, and Development activities.
  • Supports senior management governance committee meetings (e.g., Ethics Committee and Healthcare Compliance Committee) by presenting compliance updates on key initiatives and reporting metrics from the audit and monitoring program as well as any investigations.
  • Assists with the company's Healthcare Compliance continuous improvement initiatives, including but not limited to, the update, maintenance and consistent implementation of policies and SOPs.
  • Leverages data analytic skills to proactively address potential healthcare/FDA compliance issues to prevent or minimize compliance risk to the company. Works with internal stakeholders to achieve business goals within a compliance framework.
  • Participates in the investigation of complaints and alleged violations of rules, regulations, policies, procedures, and standards of conduct, and coordinates with management in developing/implementing corrective action plans, and providing general guidance on such matters.
  • Regularly reviews reports of new compliance developments from governmental agencies such as the OIG and state agencies, including fraud alerts, special advisories or proposed rules and, in conjunction with the legal department, to ensure appropriate interpretation and training regarding such developments.

SUPERVISORY RESPONSIBILITIES:

  • NONE

EDUCATION/EXPERIENCE/SKILLS:

Education:

  • BS/BA degree in related discipline and twelve years of related experience; or,
  • MS/MA degree in related discipline and ten years of related experience; or,
  • Equivalent combination of education and/or experience.

Experience:

  • Specific expertise in the best practices of healthcare compliance and auditing. Finance audit experience a plus.
  • Familiarity with the legal principles of FDA advertising and promotion regulations, the False Claims Act, Anti-Kickback Statute, OIG guidance, and the PhRMA Code required.

Knowledge/Skills/Abilities:

  • Excellent verbal and written communication skills, must be an effective communicator with strong interpersonal skills
  • Strong organizational (detail oriented), project management, and problem-solving skills
  • Ability to handle multiple tasks, prioritize appropriately and adapt quickly to new situations, and offer creative solutions to challenging problems
  • Must be responsible, conscientious, and professional
  • Ability to work under pressure to meet specific deadlines
  • Ability to work independently and also be a team player
  • Must be able to exercise common sense in carrying out tasks
  • Dedication to quality and the highest professional standards
  • Must be a self-starter and quick learner
  • Must have good judgment
  • Strong computer skills (e.g., Microsoft Office Suite (Word, Exel, PowerPoint, etc.), Visio, Internet)
  • Ability to travel

DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

  Apply here
Posted 9/7/2017