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

 

CHIEF COMPLIANCE OFFICER - Epizyme


Epizyme, named a Fierce 15 company by Fierce Biotech, ranked #1 and #2 worldwide by The Scientist in "Best Places to Work Industry", and most recently named Innovation All Star by the Boston Business Journal, has grown successfully since its founding in 2007 in Cambridge, MA. Epizyme is a clinical stage biopharmaceutical company creating targeted epigenetic therapeutics for patients with cancer. Our lead program, tazemetostat, is in Phase 2 development for the treatment of patients with non-Hodgkin lymphoma, and a Phase 2 adult and a Phase 1 pediatric study are planned in patients with a subset of genetically defined tumors including malignant rhabdoid tumors, epithelioid sarcomas, and synovial sarcomas. Epizyme owns worldwide rights to tazemetostat outside of Japan, and has started a broad Phase 2 clinical development program. Epizyme has built a proprietary product platform that the company uses to create small molecule inhibitors of a 96-member class of enzymes known as histone methyltransferases, or HMTs. HMTs are part of the system of gene regulation, referred to as epigenetics, that controls gene expression. Genetic alterations can result in changes to the activity of HMTs, making them oncogenic (cancer-causing). We seek a top notch contributor to join our culture of transparency, intensity, scientific rigor, and fun!

Primary Role / Job Purpose
The Chief Compliance Officer is responsible for the development, implementation, and oversight of the Company's compliance program. The successful candidate will partner with the Company leadership team and operating units to ensure organizational compliance with applicable laws, industry requirements, and Company policies. This position reports to the General Counsel and has direct access to the Board of Directors and its Committees for the purpose of reporting on compliance-related matters as appropriate.

The Chief Compliance Officer will establish standards and implement procedures to ensure that the Company's compliance program is effective and efficient in identifying, detecting, and correcting non-compliance. Specific responsibilities include, among other things, policy and process implementation, leading effective training programs, conducting internal monitoring and auditing, providing strategic risk management guidance, and directing investigations and corrective actions.

Key Responsibilities

  • Responsible for the development, implementation, and oversight of the Company's compliance program.
  • Periodically report to the Senior Executive Team (SET) and Board of Directors regarding the design, operation, and effectiveness of the Company's compliance program.
  • Promote a corporate culture in which compliance is a key objective in business decision-making and processes and aligned with our core values.
  • Provide guidance to the SET, operational units, and all employees on compliance matters and pertinent new legal and regulatory developments.
  • Keep abreast of compliance trends, and provide practical business solutions that maintain the Company's compliance within an evolving legal landscape.
  • Develop, implement, and periodically review policies and procedures governing business operations designed to ensure compliance with the laws and regulations applicable to the Company.
  • Develop, implement, and periodically review compliance training programs for new and existing employees to ensure a thorough understanding and appreciation of the laws and regulations that impact our operations and how to conduct business practices appropriately.
  • Develop, implement, and periodically review auditing and monitoring plans for internal and external stakeholders.
  • Conduct and/or facilitate investigations of suspected non-compliance, make recommendations regarding corrective action to the business unit, and ensure completion of any corrective action.
  • Oversee all federal and state Sunshine reporting and related healthcare compliance requirements.

Qualifications

  • Advanced degree required; JD or MBA preferred.
  • At least 10 years of experience in a healthcare or corporate compliance role in the biotech/pharma industry, including at least 5 years in a leadership role.
  • Extensive knowledge of federal/state laws and industry requirements affecting the biotech/pharma industry.
  • Experience conducting investigations and managing the investigative process.
  • Experience building a compliance department within a small to mid-sized organization preferred.
  • Strong interpersonal, collaboration, negotiation, and communication skills.
  • Clear, concise, and persuasive writing and presentation skills
  • Ability to manage a diverse and demanding workload.
  • Strong orientation to deadline and detail.
  • Embrace and champion our core values.

Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace.

  Apply here
Posted 1/30/2018

 

GLOBAL VICE PRESIDENT, PRIVACY - Walgreens Boots Alliance


Walgreens Boots Alliance Overview
Walgreens Boots Alliance (Nasdaq: WBA) is the first global pharmacy-led, health and wellbeing enterprise. The company's heritage of trusted health care services through community pharmacy care and pharmaceutical wholesaling dates back more than 100 years.

Walgreens Boots Alliance is the largest retail pharmacy, health and daily living destination across the U.S. and Europe. Walgreens Boots Alliance and the companies in which it has equity method investments together have a presence in more than 25* countries and employ more than 385,000* people. The company is a global leader in pharmacy-led, health and wellbeing retail and, together with the companies in which it has equity method investments, has more than 13,200* stores in 11* countries as well as one of the largest global pharmaceutical wholesale and distribution networks, with more than 390* distribution centers delivering to more than 230,000** pharmacies, doctors, health centers and hospitals each year in more than 20* countries. In addition, Walgreens Boots Alliance is one of the world's largest purchasers of prescription drugs and many other health and wellbeing products. The Company's size, scale, and expertise will help us to expand the supply of, and address the rising cost of, prescription drugs in the U.S. and worldwide.

The Company has:

  • unmatched pharmaceutical supply chain and procurement expertise, offering customers innovative solutions and optimal efficiencies
  • a portfolio of retail and business brands, including Walgreens, Duane Reade, Boots and Alliance Healthcare, as well as increasingly global health and beauty product brands, such as No7, Soap & Glory, Liz Earle, Sleek MakeUP and Botanics
  • diversified and robust profit pools across the U.S., Europe and key emerging markets
  • a unique platform for growth in developed and emerging markets

By leveraging these advantages and opportunities, as well as the full benefit of our best practices and expertise, Walgreens Boots Alliance will be positioned to create substantial incremental efficiency, synergy and growth opportunities.

The creation of Walgreens Boots Alliance provides an opportunity to further accelerate the development of a fully integrated, global platform for the future to provide innovative ways to address health and wellness challenges. Our Company is well positioned to expand customer offerings in existing markets and become the health and wellbeing partner of choice in emerging markets. Walgreens Boots Alliance ranks No. 1 in the Food and Drug Stores industry of Fortune magazine's 2017 list of the World's Most Admired Companies. This is the 24th consecutive year that Walgreens Boots Alliance or its predecessor company, Walgreen Co., has been named to the list.

* As of 31 August 2017, using publicly available information for AmerisourceBergen.
**For 12 months ending 31 August 2017, using publicly available information for AmerisourceBergen.


Requisition ID: N/A
Position: Full time
Open date: Jan 26
Functional area: Legal
Locations: Deerfield, IL or downtown Chicago
Required degrees: Juris Doctorate
Experience required: 8+ years
Travel: 10%
Relocation: Yes

Position Summary
Responsible for serving as the Company's Chief Privacy Officer and reporting to the Senior Vice President and Chief Compliance and Ethics Officer, as required by federal and state law for financial and healthcare organizations. Responsible for ensuring compliance with the Health Insurance Portability and Accountability Act of 1996 - HIPAA, FACTA, FTC, PCI and State privacy and breach notification laws, and any other privacy directives, as applicable. Responsible for providing legal guidance, in conjunction with the Legal Department, and for the identification, implementation, and maintenance of enterprise-wide privacy policies and procedures, across types of business. Responsible for coordinating with IT Security to ensure that data privacy and security policies, procedures and business practices are appropriately linked. Leads the Privacy Office, as an integral part of the overall Walgreen's Compliance program, to provide business relevant, timely and risk- appropriate advice necessary for the respective businesses to meet their objectives. Responsible for developing an appropriate risk identification and mitigation strategy that affects multiple functions within the company to protect it from fines, penalties and sanctions.

Position Responsibilities
Develops an appropriate risk identification and mitigation strategy that impacts multiple functions within the company to protect it from fines, penalties and sanctions. Leads and directs ongoing enterprise-wide activities related to the development and implementation of a robust privacy governance program. Holds primary responsibility for ensuring the revision, implementation, maintenance of, and adherence to the organization's policies and procedures covering the privacy of, and access to, patient health and financial information as necessary to comply with federal and state laws and the organization's information privacy practices. Leads Walgreen's privacy initiatives with respect to Walgreens Boots Alliance Development entity to ensure compliance with EU, other European and global privacy standards. Leads and directs other departments/divisions to develop specific procedural guidelines for each respective department/division. Leads the development of, and works collaboratively with multiple businesses and functions to create a means to track access to protected health information, defined by law, and to enable authorized individuals to obtain access to reports on such activity.

Functions as an integral component of the Walgreens' Compliance Department to define project scope and identify specific compliance requirements as they relate to HIPAA and financial privacy regulations and statutes. Leads privacy risk assessment, planning, and implementation for Walgreen Co. and its subsidiaries.

Provides necessary leadership and direction to multiple functions, including but not limited to, Legal, Loss Prevention, Asset Protection, Store Operations and other key areas of responsibility, manages privacy department processes and operations. In conjunction with the Chief Compliance and Ethics Officer, to whom the role reports, ensures proper escalation to appropriate area when necessary. The Privacy Department receives and then collaborates with key areas on the documentation, investigation and resolution of complaints and issues concerning privacy policies and procedures. Collaborates with appropriate area when conducting privacy incident and identity theft investigations and assists in related client management and privacy-related issues. Develops reports for senior management on privacy compliance initiatives and other areas.

Establishes processes and communication paths to ensure that the Privacy Office and Information Security are closely integrated from a policy, procedure and risk assessment basis. Must be able to establish excellent partnership relationships with other functions, including Information Security, to provide a seamless experience to the businesses.

Coordinates internal meetings/interviews and conducts workflow and gap analyses for Walgreen Co. and its subsidiaries, including analyses and reporting regarding the purchase, transfer, merger, or consolidation of various Walgreens acquisitions and business units. Determines the impact privacy legislation could have on potential new business opportunities. Acts as consultant to Walgreens by answering questions and communicating important changes/amendments to privacy legislation.

Provides ongoing guidance in the development or enhancement of various Walgreens enterprise-wide source systems and databases that contain protected health information (i.e., IC+, EDW, DSS, PLX, PBS, STARS, One Walgreens) or are required under the privacy rules (i.e., WebSDL for electronic documentation of authorizations, accounting of disclosures). Participates in Data Governance, Service Governance, and other enterprise-wide committees relating to the use/disclosure of patient and customer data.

Participates in the development, implementation, and ongoing compliance monitoring and auditing of the Walgreens' enterprise-wide operations, trading partners, and business associates to verify that privacy concerns, requirements, and responsibilities are sufficiently addressed.

Collaborates with legal counsel, management, key departments, and committees to ensure the organization has and maintains appropriate privacy and confidentiality acknowledgments, authorization forms, and information notices and materials reflecting current organization and legal practices and requirements.

Creates agreement templates (business associate agreements and related documents) and assists internal business units during contractual/relationship negotiations with outside entities that span across multiple divisions/subsidiaries to ensure that Walgreens can maximize its compliance with regulatory requirements.

Ensures compliance with privacy practices and consistent enforcement of sanctions for failure to comply with privacy policies for all individuals in the organization's workforce, extended workforce, and for all business associates, in cooperation with the HIPAA Privacy Officer, Employee Relations, the information security officer, administration, and legal counsel.

Develops and administers enterprise-wide procedures for receiving, documenting, monitoring, investigating, and taking action on all complaints concerning the organization's privacy policies and protocols. When necessary, coordinates and collaborates with both internal and external legal counsel on litigation matters relating to privacy.

Maintains current knowledge and monitors changes and amendments to federal, state, and local privacy legislation and regulations, in cooperation with legal counsel. Provides leadership and guidance to the business units regarding contractual and operational issues that implicate HIPAA, FACTA, FTC, PCI and State privacy and notification laws, and other privacy directives and assists in the contract negotiations related thereto, as required. Communicates changes/amendments to senior Company management to ensure organizational compliance, identifies privacy risks within the business, and notifies individual department heads when privacy legislation could have an impact on their departments. Leads the business in the review of any required changes to business practices necessitated by legal and/or regulatory change.

Obtains and allocates resources to achieve strategic and operating goals. Sets objectives for direct reports. Ensures the ongoing training and development of direct reports. Cultivates team morale, motivation, and loyalty through continuous training and mentorship, setting obtainable performance goals, clear communication, and constructive feedback. Provides leadership and exercises decision-making regarding priorities, best practices, methodologies, and operational execution to build and maintain a high performing team.

Ideal Qualifications & Interests

  • Juris Doctorate and at least 8 years of experience working within a publicly traded corporation and/or private law practice on privacy matters.
  • Required licensure to practice law as granted by the appropriate state licensing agency.
  • Knowledge of business systems to promote compliance, including development of enterprise-wide compliance websites and policy management systems.
  • At least 8 years of experience in a role requiring the management of projects that overlap between more than one clinical and/or business area.
  • Experience communicating regulatory and privacy issues and concepts orally and in writing to senior business leaders and their teams.
  • At least 8 years of experience diagnosing, isolating, and resolving complex privacy issues and recommending and implementing strategies to resolve problems.
  • Experience directly managing people, including hiring, developing, motivating, and directing people as they work
  • At least 8 years of experience leading teams to develop enterprise wide compliance solutions.
  • At least 8 years of experience drafting, developing, approving, implementing, managing and tracking compliance policies in large organizations.
  • Experience using time management skills, such as prioritizing, organizing and tracking details and meeting deadlines of multiple projects with varying customer satisfaction.
  • Expert knowledge of privacy laws and regulations that affect the Walgreens family of companies. EU Data Privacy and governance knowledge is preferred.
  • Experience advising publicly traded pharmacy provider on privacy, regulatory and compliance matters is strongly preferred.
  • Experience developing and delivering presentations to various audience levels within an organization is preferred.

Walgreens is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.

Additional Information
Location: Global WBA Headquarters in Deerfield, IL, a suburb of Chicago
Travel Requirements: 10%
More company information is available at www.walgreensbootsalliance.com

Contact Details
Ashley Carlile
Senior Researcher Executive Talent
Acquisition Walgreens Boots Alliance, Inc.
Ashley.Carlile@wba.com
Posted 1/29/2018

 

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 travel to 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 1/26/2018

 

ETHICS & COMPLIANCE DIRECTOR, SPECIALTY - GSK

Requisition ID: WD152532
Position: Full time
Open date: Jan 22, 2018 3:03 PM
Functional area: Finance
Locations: Philadelphia, Pennsylvania, Raleigh, North Carolina
Required degrees: Bachelors
Experience required: 5 years
Relocation: No


Your Responsibilities:
As a senior compliance leader, you will oversee compliance activities for US Pharma specialty business units to effectively manage risk, strengthen internal controls, and support business solutions that are fit for purpose. Situated on the leadership team(s) of the Respiratory Biologics and Immunology business units, you will be responsible to help identify risks early in business strategy processes and activities including, but not limited to, brand planning, advisory activities, sales force effectiveness, sales training, and promotional speaker programs. Specific responsibilities include:

  • Partnering with US Pharma and global business leaders, US Pharma Ethics & Compliance team, Global Ethics and Compliance team, Audit and Assurance, industry, and regulatory bodies to embed an ethical culture in a way that it brings commercial value to our business.
  • Leading the implementation of internal controls (e.g., policies, training, communication, management monitoring) important to enable compliant and competitive business activities.
  • Leading the development and coordinate the implementation of policies and procedures for designated business unit(s).
  • Ensuring that significant risks (e.g., regulatory, legal, execution, reputational) are proactively identified and mapped in the business unit(s), and that risk mitigation plans are developed to effectively address these compliance risks.
  • Partnering with Audit and Monitoring teams to ensure risk-based monitoring and auditing activities are effective in identifying risks and strengthening business performance.
  • Partnering with the business unit(s) to support the preparation for and response to internal audits of significant compliance risks.
  • Updating US Pharma and Ethics & Compliance management teams on the compliance programs for the specialty business units.
  • Partnering with Corporate Internal Investigations and Legal to ensure that reported concerns are promptly and thoroughly investigated, with appropriate corrective action and discipline when appropriate.

Why You?

Basic qualifications:
Your role will be crucial in supporting the business in a sustainable paradigm shift in which compliance becomes a way of working within the business and its culture. This culture (and associated ways of working) must support the delivery of the pharma business objectives-while ensuring that the business fully owns the achievement of compliance requirements. In doing so, the role must balance the differences in risk profile and business-specific compliance requirements across business units to ensure controls are fit for purpose and aligned with business objectives.

  • Bachelor's Degree in Business Administration, Law, Finance, or other applicable degree
  • At least 5 years of compliance program management, demonstrating knowledge of compliance processes, legal/regulatory requirements, and business operations.
  • Marketing and Sales experience strongly preferred, demonstrating a solid working understanding of the environment in which compliance operates.
  • Demonstrated experience learning specific pharmaceutical products, and understanding product indications and related risks.
  • Track record in providing high degree of reliance, accountability, and value-added consultation/support to business leaders.
  • Proven ability to develop and apply strategic principles and develop appropriate policy positions in support of varied business activities.
  • Experience in project management of complex, cross functional initiatives.
  • Strong analytical skills, problem diagnosis and solving, conflict management, and business judgment.
  • Strong writing and presentation skills.
  • Demonstrated confidence in challenging mind-sets, influencing leaders, and developing/implement innovative strategies and approaches.
  • Excellent interpersonal skills to enable effective and influential internal and external contacts.
  • Ability to manage highly sensitive confidential issues with complete discretion.
  • Willingness and ability to travel 20-30% for attendance at sales meetings, medical conferences, advisory boards, national/regional/local meetings, training presentations, etc.

Preferred qualifications:

  • At least 8 years of compliance program management.
  • Significant business and/or compliance client leadership experience in a global pharmaceutical or related healthcare organization.
  • At least 5 years of experience working in a pharmaceutical specialty business (e.g., immunology, oncology) and associated activities such as different product reimbursement models and distribution channels (e.g., specialty pharmacy)
  • Experience of contributing effectively at the highest levels of management as a leadership team member.
  • Ability to work effectively and sensitively in a highly matrixed organization across geographies and cultures.
  • Experience with US laws, regulations, and codes associated with engaging with patient advocacy groups, local support groups and non-profit organizations in the specialty arena.
  • Demonstrated understanding of data privacy risks associated with patient and customer-level information.
  • Experience in implementing appropriate ways of working between different customer-facing roles such as Account Specialists, Payer Relations Managers, Medical Liaisons, and Nurse Educators.

Why GSK?:
GSK has a 150-year legacy of helping to transform the health, lives and futures of millions of people around the world. We're a science-led healthcare company with more than 100,000 people working in 115 countries. Each year we produce around 4 billion packs of medicine, nearly 900 million doses of vaccine and more than 18 billion packs of consumer healthcare products. Our focus of helping people do more, feel better and live longer is at the center of all that we aim to do.

Ethics & Compliance is a critical function to ensure GSK's internal control framework is fit for purpose and employees take accountability for knowing and applying our policies. Our team's mission is to ensure the right product gets to the right patient/consumer in the right way.

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

  Ethics & Compliance Director, Specialty - Apply here
Posted 1/24/2018

 

COMPLIANCE & ETHICS BUSINESS PARTNER - Alexion


Position Summary
The Compliance and Ethics Business Partner directs Alexion's compliance program for key US businesses. The role serves as a trusted advisor to commercial business leaders, drives the development and implementation of local programs, instills a business aligned compliance culture and implements Alexion's global ethics and compliance strategy. Reporting to the Executive Director, US. & Enterprise Compliance, the Business Partner serves as a member of business leadership teams supported and contributes to Alexion's evolving global compliance strategy and culture.

Job Duties & Responsibilities
Serves as a the primary business partner for Alexion's operations and employees, providing business, ethics and compliance advice to enhance business and commercial operations. They will own the responsibility for driving the Compliance program for the business unit. Is actively involved and engaged across multiple business functions. Accountable for the following:

  • Serves as a strategic advisor to business leadership to provide compliance-based input and direction to ongoing business and commercial go-to-market strategies and tactics.
  • Provides compliance guidance with respect to sales and marketing tactics, HCP and Patient engagement programs and ensures alignment with Medical Affairs colleagues and compliance initiatives.

Independently drives the development, implementation and management of the compliance program, including policy, process, training, communication, programs and systems for their business unit. Will serve as a Compliance subject matter expert for the business unit and will partner with the Business Unit Lead and team to set the strategic tone and align tactical direction for the business. Analyzes internal and external ethics and compliance developments and needs across the businesses and functions supported. Accountable for the following:

  • Analyzes compliance needs based on the business model, product lifecycle and external factors; develops targeted guidance, policies and training to address BU specific issues.
  • Develops formal and informal communications to deliver compliance program key messages.
  • Rolls out Compliance policies to field teams.
  • Maintains updated understanding of requirements around DOJ and OIG reporting requirements; appropriate knowledge of guidelines under which MSL's, sales representatives and commercial teams can operate.
  • Monitors the external environment to ensure the implementation of external best practices as well as to respond to future business, ethics and compliance developments.
  • Supports compliance investigations and audits; develops communication strategies with business leaders on process, expectations, and messaging to their teams.
  • Addresses Compliance hotline inquiries.
  • Partners with internal teams to address compliance risk areas, including anti-bribery/anti-corruption, transparency, privacy interactions with health care providers and others.
  • Provides local perspectives and input into broader compliance program management including Transparency, Monitoring and Investigations processes.

Accountable for:

  • Strategic partnership and advice to business leaders on compliance matters.
  • Inspiring a business aligned, proactive compliance culture.
  • Development, implementation and delivery of US and global compliance programs for all employees across the business supported.

Essential Qualifications

  • Minimum of 10 years' experience in the pharmaceutical industry in a compliance, legal or regulatory related role or experience in a consulting firm working with clients on compliance programs.
  • Knowledge of Pharmaceutical industry regulations.
  • Understands the U.S. Biotechnology / Pharmaceutical industry and therapeutic areas, as well as the nuances of the business culture that impact business processes and compliance.
  • Deep knowledge of the PhRMA Code as well as the U.S. transparency guidelines.
  • Excellent communication skills both written and verbal.
  • Excellent interpersonal skills with demonstrated track record and ability to drive results as an effective a team member and leader.
  • Proven ability to consultant and advise, demonstrating both compliance and commercial acumen.
  • Strong sense of ethics and responsibility.
  • Ability to travel as required to meet business need.

Preferred Qualifications

  • Law degree strongly preferred.
  • Ability to work collaboratively with other leaders, and with external partners.
  • Flexibility and ability to adapt to changing conditions.

  Director Compliance & Ethics R&D - Apply here
Posted 1/22/2018

 

DIRECTOR, ENTERPRISE PROGRAMS - Alexion


Position Summary
The Director, Enterprise Programs is responsible for the development and execution of an enterprise wide compliance strategy, framework and communication platform for integrated and consistent management of compliance programs. The role will have accountability for enterprise program strategies related to training, communications and incentives. The role will take a holistic approach to developing a culture of compliance that is ultimately distilled to the employee level; ensuring compliance with business policies and programs, regulatory and legal requirements. The Director, Enterprise Programs reports directly to the Executive Director, US. & Enterprise Compliance and contributes to organization's Global Compliance Strategy.

Job Duties & Responsibilities
Develops a comprehensive enterprise-wide strategic plan to build a portfolio of compliance activities and programs to drive a cultural change. Accountable for the following:

  • Obtains a baseline understanding of existing compliance program effectiveness (e.g. surveys, data analysis, interviews) to align with identified strategies and determine targeted outcomes.
  • Defines and develops the enterprise wide compliance programs, taking the entire employee life cycle in frame considering establishing the culture and focus of experience from new hire training through ongoing interfaces with all programs and policies that must be considered through a compliance lens.
  • Partners with external teams to understand engagement opportunities and leverage internal and external programs to build regular touch-points with employees and assess how a compliance culture is rewarded.
  • Provides leadership, consultation and advice to Regional Compliance Business Partners and other internal teams who develop and execute on the tactics to stand up and/or support the global programs; partner with business teams to roll-out joint training activities.
  • Provides an enterprise-wide perspective on where partnerships and opportunities can be managed through a corporate approach.

Develops an organization-wide communication strategy for compliance programs. Accountable for the following:

  • Defines the messaging of the compliance culture and communication in support of the business and employee needs.
  • Determines an approach and cadence for how the organization positions compliance programs and values, and communicate to employees.
  • Develops a mechanism to continually seek feedback into program and communication activities.

Manages the company's Code of Conduct training program. Accountable for the following:

  • Determines an organization-wide approach to developing the concepts and content, manner in which training will be conducted and delivered, socialization of the training with the business and implementation of training program to employees.
  • Determines how to effectively engage with employees and enable them to be champions of compliance programs.
  • Determines effective feedback loops and mechanisms to ensure program currency and effectiveness as both the business and world of work evolves.

Accountable for:

  • Developing and implementation an enterprise strategy, framework and communication platform for integrated and consistent management of compliance programs.
  • Management of Alexion's Code of Conduct training program.

Essential Qualifications

  • Advanced degree and 8-10 year's experience with compliance program involvement and oversight. Experience can be through a combination of sales, marketing, HR, or internal compliance function or through external consulting firm experience working with compliance programs on behalf of clients.
  • Knowledge of Pharmaceutical industry regulations.
  • Excellent communication skills both written and verbal.
  • Excellent interpersonal skills with demonstrated track record and ability to drive results as an effective a team member and leader.
  • Creative thinking to design and present compliance programs in a marketed way.
  • Strong sense of ethics and responsibility.
  • Ability to travel as required to meet business need.

Preferred Qualifications

  • Prior Biotechnology/pharmaceutical industry experience strongly preferred.
  • Project management experience to manage cross-functional teams and vendors within timeframe and resource constraints.
  • Ability to work collaboratively with other Compliance leaders, and with external partners.
  • Flexibility and ability to adapt to changing conditions.

  Director Enterprise Compliance - Apply here
Posted 1/22/2018

 

DIRECTOR, MONITORING - Alexion


Position Summary
The Director, Monitoring is responsible for the development and implementation of preventative and proactive compliance monitoring activities for the US organization. This role determines the activities, sources, and methods to monitor compliance with business practices, policies, laws and regulations. The job holder takes a consultative and business oriented approach; role models a culture of compliance and proactivity through leadership of the monitoring function. The Director, Monitoring reports directly to the Executive Director, US. & Enterprise Compliance and contributes to the US compliance strategy.

Job Duties & Responsibilities
Develops, builds and implements compliance monitoring programs and solutions for US Commercial and Sales activities to ensure compliance with internal and external policies, laws and regulations. Accountable for the following:

  • Identifies promotional practice and related risk areas by assessing the execution of existing compliance programs through in-person reviews and data analysis.
    • Attends in-person events such as speaker events or patient forums to monitor execution of compliance activities.
    • Participates in sales force field rides.
    • Reviews data for compliance through various means such as review of call volumes for sales representatives to healthcare providers, off-label utilization, speaker program attendance, ad boards, email reviews, prescribing numbers, etc.
  • Develops mechanisms to proactively monitor compliance activities based on consultation with business partners on emerging issues and a forward-looking mindset.
  • Stays abreast of changes to laws and regulations with healthcare compliance related to promotional activities.

Partners with internal teams on an integrated approach to compliance and ensures program objectives are met. Accountable for the following:

  • Communicates with Business Partners and Transparency teams on field-level activities to keep abreast of emerging issues at the regional level; collaborates on ways to mitigate risk through insights derived from monitoring results.
  • Identifies gaps in sales and marketing team training programs through monitoring activities and partners with Business Partners to develop content for targeted training programs.
  • Identifies potential hands-off to the Compliance Investigations team for follow up.
  • Performs ad hoc monitoring as needed to support non-commercial compliance activities.

Determines sources and use of systems, data and processes to support real-time monitoring and decision-making activities. Accountable for the following:

  • Identifies opportunities to utilize and/or enhance technical systems and databases to support data capture, reporting and analysis.
  • Develops reports and presents findings for stakeholders.

Accountable for:

  • Development and implementation of compliance monitoring programs and solutions for US business operations.
  • Development of tools and resources to support the collection of data and analytics to support real-time monitoring.
  • Partnership with internal teams for the ongoing management, proactive improvement and monitoring of compliance programs.

Essential Qualifications

  • Advanced degree and 8-10 years' experience in a monitoring program role within a compliance, legal, internal or field audit, or risk function.
  • Prior Biotechnology/Pharmaceutical industry experience including knowledge of therapeutic areas.
  • Knowledge of Pharmaceutical and related healthcare compliance regulations.
  • Excellent communication skills both written and verbal; developing and presenting communications, recommendations and findings to leadership teams.
  • Excellent problem solving and analysis skills including use of data analysis tools; ability to see trends and convert information to insights.
  • Excellent interpersonal skills with demonstrated track record and ability to drive results as an effective a team member and leader.
  • Strong sense of ethics and responsibility.
  • Ability to travel as required to meet business need.

Preferred Qualifications

  • Prior experience with data visualization and analytics software such as Spotfire or Tableau.
  • Demonstrated ability to work collaboratively with other Compliance leaders, and with external partners.
  • Flexibility and ability to adapt to changing conditions.

  Director Monitoring - Apply here
Posted 1/22/2018

 

DIRECTOR, TRANSPARENCY & COMPLIANCE OPERATIONS - Alexion


Position Summary
The Director, Transparency & Compliance Operations is responsible for defining and implementing the transparency and aggregate spend compliance strategies and programs for the organization. The Director acts as a subject matter expert translating Centers for Medicare and Medicaid Services (CMS), Fair Market Value (FMV) and Healthcare Professionals and Organizations (HCP/O) reporting requirements into the development of policies, procedures and training programs to ensure Alexion meets federal and local compliance requirements. The job holder takes a consultative and business oriented approach; role models a culture of compliance and proactivity through leadership of the transparency and aggregate spend function. The Director, Transparency / Aggregate Spend reports directly to the Executive Director, US. & Enterprise Compliance and contributes to the US compliance strategy.

Job Duties & Responsibilities
Develops the strategies, standards, and processes by which Alexion will capture, manage and report Aggregate Spend and transparency data to regulatory agencies. Accountable for the following:

  • Designs business processes, programs and strategies to ensure organization-wide compliance with reporting requirements; develops processes to ensure US Commercial and Sales teams comply with established policies.
  • In partnership with Finance, identifies, tests and refines process for capturing and reporting payments in the General Ledger.
  • Makes recommendations on changes to processes, systems, tools and resources used to manage transparency and aggregate spend programs.
  • Develops policies and procedures covering both internal and external resources (e.g. vendor management) to ensure accuracy and timeliness in data capture and reporting.
  • Corresponds with CMS or other regulatory agencies on enquiries related to reported information.

Partners with internal teams on an integrated approach to compliance and to ensure program objectives are met. Accountable for the following:

  • Identifies issues at the field level with sales and marketing teams and provides guidance and collaboration with Compliance Business Partners on solutions to mitigate the risks through training, policies and communication.
  • Identifies trends or outliers that require hand-off to the Monitoring team to provide ongoing review and monitoring; takes a proactive forward looking approach to integrating with other parts of the compliance functions.
  • Partners across both the compliance and finance functions to ensure proactive anticipation of trends and to ensure both efficiency and effectiveness in current and anticipated approaches.
  • Manages execution and completion of HCP Engagement related processes across all relevant Alexion entities, working across key functional areas (e.g., Legal, Finance, Sales/Marketing, IT, etc.), global stakeholders, third party vendors, and IT system vendors.
  • Ensures that activities in Globally related to Transparency are aligned with Corporate Compliance objectives.
  • Executes on strategy, policy, and procedures related to HCP Engagement/Transparency. Holds peers accountable for quality and timeliness on their execution;
  • Visibility to, and understanding of, Alexion's internal data and finance systems, including: Master Data Management, SAP, Concur, etc.

Accountable for:

  • Development of programs to ensure compliance with Transparency and Aggregate Spend regulations.
  • Identification and implementation of end to end processes to capture, audit, report, and ongoing management of data related to programs.

Essential Qualifications

  • Advanced degree and 8-10 years' experience managing transparency / aggregate spend programs.
  • Prior Biotechnology/Pharmaceutical industry experience.
  • Excellent communication skills both written and verbal; developing and presenting communications, recommendations and findings to leadership teams.
  • Excellent problem solving and analysis skills including use of analysis tools and understanding of related finance processes and methods.
  • Excellent problem solving and analysis skills.
  • Excellent interpersonal skills with demonstrated track record and ability to drive results as an effective a team member and leader.
  • Strong sense of ethics and responsibility.
  • Ability to travel as required to meet business need.

Preferred Qualifications

  • Ability to work collaboratively with other Compliance leaders, and with external partners.
  • Flexibility and ability to adapt to changing conditions.

  Director Transparency - Apply here
Posted 1/22/2018

 

DIRECTOR, ETHICS & COMPLIANCE FUNCTIONAL ADVISOR, PA/HP - Novartis Pharmaceuticals
JOB ID: 225096BR
JOB LOCATION: East Hanover, NJ


Job Description:
To provide independent, strategic business partnership with the Patient Access/Health Policy (PA/HP) Function to anticipate and identify proactive strategies/solutions to address business needs and potential risks, and help ensure that activities and processes comply with all applicable NPC policies, laws, regulations and professional codes of conduct.

Major Accountabilities:

  • Competent, Compliance Advisory Services: Provide sound leadership and business decision advisory support to the PA/HP Function as the primary and independent compliance consultant to help enable the achievement of business goals, objectives, and innovative new approaches in a manner that achieves compliance with company policy, laws and regulations, relevant guidance, codes and Corporate Integrity Agreement requirements
  • Strategic Vision Alignment: Lead the development of a Vision for the Compliance Program and related culture of integrity and compliance for assigned Function, in collaboration with the Function Unit Head and Chief Compliance Officer; this should set the direction for the aligned approach to compliance, as well as establish key metrics for evaluation within the Business Unit; this execution is to be led by the Function Unit Head and his/her Leadership Team
  • Risk Assessment, Monitoring, Remediation Plans: Strategic advisor to help guide the Function's development and administration of their Risk Assessment Plan, related self-monitoring plans, aggregated NPC risks and any other relevant remediation plans, with feedback loops to E&C for measurement and reporting
  • Monitoring and Investigations Oversight: complete relevant training in order to effectively conduct compliance monitoring and inquiries assigned by the BPO related to respective Function according to BPO/E&C protocols, and report results to E&C; identify and oversee inquiries for review and coaching by the function with results reporting to E&C
  • Compliance Reporting, Data Analytics, and Root Cause Analysis: Serve as Function/E&C liaison to help ensure effective and comprehensive awareness and action plan development related to the results of any dashboard/KPI metrics and reporting pertaining to the effectiveness of the compliance program as it relates to specific Function activities and results, or proactively to address NPC organization trends.
  • Trends and Knowledge Sharing: Provide current information for the function on known and foreseen internal and external compliance trends to proactively guide and adjust business initiatives accordingly
  • CIA Compliance: Partner with CIA team and functional areas to ensure effective, timely and complete execution of all CIA-related deliverables and any relevant audit remediation within assigned Function
  • Business Insights: Drive education and strategic knowledge of E&C associates related to the products, strategies, and trends of assigned Functional Unit
  • Compliance Projects: Drive execution within assigned Function of new compliance-related policies, initiatives or projects
  • "Speak Up" Culture: Promote and facilitate a continuous learning environment via the identification and communication of actual or suspected gaps or failure to adhere to NPC policy, laws and regulations by Functional associates in accordance with NPC Code of Conduct reporting obligations
  • Continuous Learning: Develop and administer Function specific educational programs and training consistent with the core goals of E&C educational curriculum, with further specificity to address Function needs in coordination with Head of E&C Learning & Education, and across other Functional & BU advisors for consistency
  • Ad-Hoc Projects: Other ad-hoc compliance projects as assigned.
  • Contribute as active member of E&C Leadership Team and respective Functional Leadership Team

Key Performance Indicators:

  • Alignment and ownership of E&C Strategy and setting unique Function vision for compliance program by Functional Leadership.
  • Culture of integrity and compliance within the Function as measured by relevant surveys (e.g., GES, CIA independent expert reports and focus groups, etc.)
  • Trust built with all Functional Associates (e.g., measures of accessibility, solutions orientation, ability to effectively and appropriately advise under challenging or controversial circumstances)
  • Number/Nature of policy violations from Function, including responsiveness in remediating in timely manner and sustained outcome of compliance
  • Quality/speed of advice provided to resolve issues, including consistency of advice (requiring strong collaboration across E&C and with Functional Legal partner

Minimum Requirements:
   Education
(minimum/desirable):

  • Bachelor's Degree or equivalent 4 Year University Degree required
  • Advanced degree e.g., Masters in Juris Prudence, JD, or other high-level education relevant to the practice of law and/or healthcare compliance expertise preferred
  • Completion of relevant certification program preferred (e.g., Seton Hall Healthcare Compliance Certification, ECI LPEC Certification)

Experience:

  • >10 years' experience in the pharmaceutical industry
  • In depth understanding of the operations of a pharmaceutical company including manufacturing, marketing, sales, and distribution.
  • Strong knowledge of relevant regulatory/compliance requirements (e.g., Federal HealthCare Program and FDA laws, regulations, codes, guidances (e.g., OIG program guidance), Federal Sentencing Guidelines, NPC CIA
  • Strong Knowledge of Managed Health Care Environment, Contracting, and/or Patient Services including relevant regulations.
  • Understanding of Specialty Pharmacies and related service providers

Skills/Competencies:

  • Excellent interpersonal skills and ability to develop trusting relationships with stakeholders
  • Strong partnering skills to identify and leverage knowledge from across the organization
  • Excellent analytical/reasoning, problem solving, organizational and multi-tasking skills
  • Strong policy, process and project management skills
  • Excellent presentation skills and executive presence.
  • Experience developing content and delivering quality education programs
  • Demonstrated ability to establish strong external networks accessed and relationships built with experts in the field, industry peers and regulatory authorities to remain current on compliance and other industry related trends
  • Demonstrated ability to prepare and deliver analytical, written and oral communications appropriate for multiple audiences and levels within the organization
  • Demonstrated track record of partnering with business to establish a common vision to enhancing business performance
  • 20-30% travel required

  Apply here
Posted 1/8/2018

 

GLOBAL PRIVACY OFFICER - Incyte Corporation
LOCATION: Wilmington, Delaware


Role Description
The Global Privacy Officer will lead Incyte's Privacy program, working with legal counsel, business units, and IT to ensure that Incyte is in compliance with all global, federal and state privacy and data protection laws and regulations. The Privacy Officer will drive the development and implementation of all privacy processes and procedures in an effective and efficient manner and will provide guidance regarding privacy implications of various business opportunities.

The Global Privacy Officer reports to the Chief Compliance Officer.

Responsibilities:

  • Develop and execute against annual Privacy Compliance Plan
  • Work with senior management and IT to ensure the organization adopts consistent and harmonized approaches to processing personal information and patient data
  • Ensure any transfers of personal information and patient data comply with all applicable laws
  • Create and maintain internal corporate policies that are consistent with applicable privacy and data protection laws
  • Investigate and address all inquiries and complaints regarding Incyte's privacy policies in collaboration with IT, Legal and other internal and external groups as necessary, and consistent with Incyte's Compliance Investigation process and procedures
  • Remain current on and keep management up-to-date regarding any changes to applicable privacy and data protection laws, trends, and best practices
  • Train employees on company privacy policies, data handling practices and procedures, and legal obligations
  • In coordination with the data breach response team, lead Incyte's response to data breach events
  • Assist in assessing contracts in which the organization has disclosed or outsourced the processing of personal information to third-party vendors and assist with vetting those vendors where necessary
  • Record processing activities in collaboration with IT and business units
  • Manage the Privacy Impact Assessment process
  • Manage Incyte's records retention program
  • Develop and manage an audit program to monitor compliance with privacy program processes and procedures
  • Work with IT and management to ensure appropriate technical solutions are in place to protect personal information
  • Prepare and present reports on privacy risks, metrics, and compliance activities to key stakeholders and senior management
  • Cooperate with and handle communications with data protection regulators and data subjects

Skills & Experience:

  • Law degree and/or Master's degree in public health or healthcare compliance
    • Education or certification in Privacy and/or Data Protection preferred
  • Experience in privacy, compliance and/or managing a privacy program within the pharmaceutical/medical device industries
  • Understanding of relevant legal, regulatory, compliance, and business environment relevant to the pharmaceutical industry
  • Technically-minded with the ability to analyze data protection and processing issues within the context of IT systems, web based technologies, and functions
  • Detail-oriented
  • Ability to work independently and make strategic decisions as they relate to privacy and Incyte's business operations
  • Ability to manage multiple priorities with strong organizational, management and decision-making skills
  • Excellent communication, presentation, and writing skills including the ability to communicate effectively through presentations and individual discussions with all levels of the organization
  • Ability to influence key decision makers
  • Able to proactively identify issues and develop business-friendly solutions
  • Results-oriented, team player, and able to work well with all levels of the organization
  • Fluent in English with ability to speak other languages preferred

  Apply here
Posted 12/4/2017