The Pharmaceutical Compliance Forum

Employment

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EMPLOYMENT OPPORTUNITIES

 

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

 

MANAGER, CORPORATE COMPLIANCE - Mallinckrodt Pharmaceuticals. Bedminster, NJ.


SUMMARY OF POSITION:
The Corporate Compliance Manager will report to the Direct of Compliance Program Management and will provide subject matter expertise and support for Mallinckrodt's Compliance Program including development ofsystems, policies, process and training. The Compliance Manager will be asked to work with various cross-functional organizations including commercial, legal, regulatory, and medical to identify areas that will benefit from a system, corporate policy or set of procedures to guide company activities related to commercial and medical.

ESSENTIAL FUNCTIONS:
Primary responsibilities will include, but are not limited to:

  • Draft and implement process and systems to support compliance policies;
  • Develop and implement Healthcare Provider (HCP) engagement tool to manage annual budgeting plans, needs assessments and Fair Market Value (FMV) process;
  • Manage FMV process;
  • Collect quarterly/annual budget plans for activities involving US HCPs;
  • Ensure appropriate FMV, debarment checks and manage compliance reconciliation of HCP activities;
  • Implement Compliance Training Plan including development of curriculum;
  • Collaborate with company LMS Training team to implement web based compliance training, develop training assignment criteria, and escalation protocols and develop reporting or dashboards to measure compliance with training;
  • Develop and execute Compliance Communication Plans
  • Support day-to-day compliance department needs

MINIMUM REQUIREMENTS:

  • BS, BA from accredited university;
  • Minimum of 5 years of professional experience with a minimum of 5 years in Healthcare Compliance experience or Compliance operations;
  • Strong analytical and reporting skills;
  • Strong working knowledge (intermediate to advanced skills) in Microsoft Office Applications;
  • Proficiency in database management (SharePoint);
  • Strong project and time management skills with the ability to handle multiple tasks, set priorities, meet deadlines, and develop process efficiencies where required;
  • Able to prioritize and act with a sense of urgency when required;
  • Able to work independently and know when to appropriately escalate an issue for resolution;
  • Capacity of problem solving - anticipating, initiating and resolving issues
  • Demonstrated ability to communicate effectively with individuals up, down, and across the organization.

  Apply here
Posted 11/14/2017