The Pharmaceutical Compliance Forum

Employment

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EMPLOYMENT OPPORTUNITIES

 

SENIOR COMPLIANCE OPERATIONS MANAGER - Exelixis
Location: Alameda, CA
Salary Grade: 10
Division: General & Administration
Department: 10015 Compliance
FLSA Status: Exempt
Reports To: VP, Head of Compliance
Effective Date: August 2019

SUMMARY: The Senior Compliance Operations Manager will assist in maintaining and enhancing Exelixis' Compliance Program. More specifically, the individual will be responsible for developing, implementing, and supporting healthcare compliance practices, systems, and processes, with an emphasis on business integrity, operational excellence, and practicality. The Company's healthcare compliance audit and monitoring program will be a primary focus for this role, including maintaining the systems needed to enable the company to track and evaluate compliance of its ongoing activities. To that end, this position will be responsible for performing audits of and monitoring of Company interactions with members of the healthcare community and facilitating internal reporting. In addition, this individual will be responsible for evaluation of materials submitted for review and approval, including serving as the owner for COMPASS, the Company's HCP engagement system. Of similar priority will be support of governance committee meetings. The essential business partners for this role are corresponding positions in Sales, Marketing, Market Access, Commercial Operations, Medical Affairs, and HR.


ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Responsible for the successful implementation and execution of the audit and monitoring program, including development of tools, performance standards, and completion of corrective action. In this role, the individual will need to be a strategic partner to the Commercial and Medical Affairs organizations to ensure that the program evolves as the company grows.
  • 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.
  • 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, reviews and approves advisory board meetings, speaker programs, and otherCommercial and Medical Affairs 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.
  • Supports investigations of potential violations of law or company policy and/or ethical standards related to healthcare ethics and compliance matters, provides competent reports on the results of the investigations, and assists with the determination of corrective actions and the implementation of follow up actions.
  • Conducts root cause analyses to understand factors contributing to potential policy violations, develops recommendations, and assists with the design of controls and standards for identified gaps from audit and monitoring activities.
  • Develops and facilitates implementation of corrective action protocols for detected deviations from policy or applicable requirements.
  • Leverages investigative analytics to share actionable insights with key stakeholders. This includes creating trending analysis and the management and utilization of the investigative case matter management system to drive program improvements and organizational understanding of compliance risks.
  • Prepares timely, accurate, and complete reports with corrective action recommendations, including text summaries and graphical presentations of key data, and follow-through with key stakeholders for implementation.
  • Assists in the audit and monitoring of company activities, including field ride-alongs, speaker programs, and advisory boards.
  • 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.
  • Performs other duties as assigned/requested.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • None

EDUCATION/EXPERIENCE/SKILLS:
   Education/Certifications:

  • BS/BA degree in related discipline and 8 years relevant industry experience, or;
  • MS/MA degree in related discipline and 6 years of relevant industry experience; or,
  • Equivalent combination of education and/or experience.
  • CPA, CIA, CFE, CCEP certifications a plus.
   Experience:

  • Prior healthcare compliance related investigations experience with demonstrated independent oversight and significant caseload management required. Must have actual experience in conducting and leading investigations from commencement through to conclusion.
  • 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.
  • Experience with Polaris software and/or Tableau is a plus.
   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, Excel, PowerPoint, etc.), Visio, Internet)
  • Ability to travel domestically 35%

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 7/19/2019

SENIOR COMPLIANCE COUNSEL, NEUROLOGY AND IMMUNOLOGY - EMD Serono
Location: Rockland, MA

A career with EMD Serono is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.

Your role:
Reporting to the SVP of Compliance for North America, the Senior Compliance Counsel will be empowered to lead the efforts to build the compliance program with focus on governance, risk assessment, policies and procedures, training, monitoring, investigations, and management. This counsel will lead compliance for EMD Serono's Neurology and Immunology franchises in the US.

  • Design and implement the compliance program and strategy for EMD Serono Canada ensuring alignment with a US compliance programs.
  • Develop relationships with key stakeholders throughout the company and promote compliance program.
  • Design, develop, and advance compliance training programs and processes that align to the expected organizational standards and ensure compliance awareness is maintained.
  • Act as a channel of communication to receive and direct global and local compliance information appropriately.
  • Identify business strategies and tactics that present compliance risk and provide input into compliance risk assessment and mitigation remediation strategies.
  • Support compliance investigations through collection of information and facilitation of interviews between investigations team and business stakeholders and support implementation of corrective action measures.
  • Identify promotional practice and related risk areas by assessing the execution of existing compliance programs
  • Communicate with Business Partners on field-level activities to keep abreast of emerging issues at the regional level
  • Identify gaps in sales and marketing team training programs through monitoring activities
  • Stay up to date of changes to laws and regulations with healthcare compliance related to promotional activities

Who you are:

  • Juris Doctorate
  • Minimum of 7 years of work experience in a Legal or Compliance function with a multi-national organization with specialization in Pharmaceutical compliance, law and regulations.
  • Senior level collaborator with ability to influence and gain buy in at the leadership level.
  • Established reputation for excellence in traits such as credibility, integrity, confidentiality, and trust.
  • Collaboratively work across department and geographies and encourage teamwork that respects backgrounds and culture diversity.
  • Innovative approach, creative thinker.
  • Embracing new opportunities that will shape the future.
  • Driving innovative changes t-open to new ideas and working in a decisive.
  • Participate in a feedback culture and take responsibility.

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Find more information at https://jobs.vibrantm.com.
 Apply here
Posted 7/13/2019

COMPLIANCE COUNSEL, NORTH AMERICA (US AND CAN) - EMD Serono
Location: Rockland, MA

A career with EMD Serono is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.

Your role:
Reporting to the SVP of Compliance for North America, the Compliance Counsel, North America will be empowered to lead the efforts to build the compliance program with focus on governance, risk assessment, policies and procedures, training, monitoring, investigations, and management. This counsel will lead compliance for EMD Serono, Canada and support the Chief Compliance Officer in supporting Fertility and Endocrinology for US.

  • Design and implement the compliance program and strategy for EMD Serono Canada ensuring alignment with the US compliance programs.
  • Develop relationships with key stakeholders throughout the company and promote compliance program.
  • Design, develop, and advance compliance training programs and processes that align to the expected organizational standards and ensure compliance awareness is maintained.
  • Act as a channel of communication to receive and direct global and local compliance information appropriately.
  • Identify business strategies and tactics that present compliance risk and provide input into compliance risk assessment and mitigation remediation strategies.
  • Support compliance investigations through collection of information and facilitation of interviews between investigations team and business stakeholders and support implementation of corrective action measures.
  • Identify promotional practice and related risk areas by assessing the execution of existing compliance programs
  • Communicate with Business Partners on field-level activities to keep abreast of emerging issues at the regional level
  • Identify gaps in sales and marketing team training programs through monitoring activities
  • Stay up to date of changes to laws and regulations with healthcare compliance related to promotional activities

Who you are:

  • Juris Doctorate
  • Minimum of 5 years of work experience in a Legal or Compliance function with a multi-national organization with specialization in Pharmaceutical compliance, law and regulations.
  • Senior level collaborator with ability to influence and gain buy in at the leadership level.
  • Established reputation for excellence in traits such as credibility, integrity, confidentiality, and trust.
  • Collaboratively work across department and geographies and encourage teamwork that respects backgrounds and culture diversity.
  • Innovative approach, creative thinker.
  • Embracing new opportunities that will shape the future.
  • Driving innovative changes t-open to new ideas and working in a decisive.
  • Participate in a feedback culture and take responsibility.

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Find more information at https://jobs.vibrantm.com.
 Apply here
Posted 7/13/2019

SENIOR COMPLIANCE COUNSEL, ONCOLOGY - EMD Serono
Location: Rockland, MA

A career with EMD Serono is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.

Your role:
Reporting to the SVP of Compliance for North America, the Senior Compliance Counsel will be empowered to lead the efforts to build the compliance program with focus on governance, risk assessment, policies and procedures, training, monitoring, investigations, and management. This counsel will lead compliance for EMD Serono's Oncology franchise in the US.

  • Design and implement the compliance program and strategy for EMD Serono Canada ensuring alignment with the US compliance programs.
  • Develop relationships with key stakeholders throughout the company and promote compliance program.
  • Design, develop, and advance compliance training programs and processes that align to the expected organizational standards and ensure compliance awareness is maintained.
  • Act as a channel of communication to receive and direct global and local compliance information appropriately.
  • Identify business strategies and tactics that present compliance risk and provide input into compliance risk assessment and mitigation remediation strategies.
  • Support compliance investigations through collection of information and facilitation of interviews between investigations team and business stakeholders and support implementation of corrective action measures.
  • Identify promotional practice and related risk areas by assessing the execution of existing compliance programs
  • Communicate with Business Partners on field-level activities to keep abreast of emerging issues at the regional level
  • Identify gaps in sales and marketing team training programs through monitoring activities
  • Stay up to date of changes to laws and regulations with healthcare compliance related to promotional activities

Who you are:

  • Juris Doctorate
  • Minimum of 7 years of work experience in a Legal or Compliance function with a multi-national organization with specialization in Pharmaceutical compliance, law and regulations.
  • Senior level collaborator with ability to influence and gain buy in at the leadership level.
  • Established reputation for excellence in traits such as credibility, integrity, confidentiality, and trust.
  • Collaboratively work across department and geographies and encourage teamwork that respects backgrounds and culture diversity.
  • Innovative approach, creative thinker.
  • Embracing new opportunities that will shape the future.
  • Driving innovative changes t-open to new ideas and working in a decisive.
  • Participate in a feedback culture and take responsibility.

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Find more information at https://jobs.vibrantm.com.
 Apply here
Posted 7/13/2019

COMPLIANCE LEAD, BUSINESS INTEGRITY AND ETHICS --- OR --- LEAD, ETHICS & COMPLIANCE AUDITING AND MONITORING - EMD Serono
Location: Rockland, MA

Your role:
The Integrity and Ethics Operations Lead is responsible for executing against the EMD Serono Compliance Department's annual Monitoring & Auditing (M&A) strategic plan. The lead will conduct monitoring activities and audits of various company records, manage the development and implementation of remediation & mitigation processes, assist with investigations related to findings and allegations of non-compliance with Company policy, prepare regular reports and presentations in a form that is consistent with internal and external reporting requirements.

  • Monitor field Commercial, Medical Affairs and Managed Markets transactions, activities, and processes and perform transactional monitoring to assess compliance with Company policies and procedures.
  • 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 for employees, senior management.
  • Develop and demonstrate knowledge and competency to serve as a compliance and ethics subject matter expert.
  • Support the Chief Compliance Officer and other leaders in Compliance with E&C Monitoring & Auditing in facilitating and raising awareness of the Ethics & Compliance program while fostering accountability for compliance throughout the organization.
  • Maintain understanding of laws and regulations, enforcement actions and evolving practices relevant to pharmaceutical compliance and proposes updates to ethics & compliance program, as appropriate.
  • Identify, analyze, and mitigate potential business and ethics risks to the organization.
  • Support the development and manage the implementation of a robust ethics and compliance monitoring and auditing plan.
  • Develop and maintain knowledge and understanding of EMD Serono's disease states and products and industry regulations and guidelines - laws and regulations regarding pharmaceutical advertising and promotion, Federal Anti-Kickback Statute, False Claims Act, as well as EMD Serono policies and procedures, and government reporting requirements as needed.
  • Develop and manage protocols, guidelines and associated internal communication and documentation related to E&C testing and monitoring.
  • Develop and manage the remediation and mitigation process on for the M&A team
  • Review records and systems relating to interactions with healthcare professionals and institutions, conduct field monitoring visits and monitor various company-sponsored activities to ensure adherence with relevant laws, regulations, industry codes, and company policies.
  • Support E&C audits for North America with the potential to gain exposure to global activities in support of annual auditing plan and/or ad hoc audits as requested.
  • Review and follow-up on suspected areas of non-compliance and collaborate with EMD Serono Ethics & Compliance teams as needed.
  • Prepare reports and presentations summarizing monitoring and auditing findings and remediation for management and external government agencies as requested.

Who you are:

  • Extensive working knowledge of US and international fraud and abuse laws and regulations - such as the False Claims Act, the Anti-Kickback Statute, the Foreign Corrupt Practices Act, and the UK Bribery Act - and should have experience working with or for biotechnology/pharmaceutical companies on these issues.
  • Ability to work collaboratively and strategically with colleagues in legal and the business to drive a culture of ethics and integrity across the global organization.
  • Bachelor's degree from an accredited institution required
  • A minimum of 5 years combined pharmaceutical, legal, regulatory, and compliance experience required.
  • Demonstrated knowledge and understanding of the Anti-Kickback Statute and False Claims Act, Food & Drug Administration (FDA) rules and regulations regarding the promotion of pharmaceuticals, corporate integrity agreements, PhRMA code, and other relevant reporting requirements.
  • Compliance monitoring and auditing experience in the Pharmaceutical or life sciences industry is strongly preferred.
  • Experience working under a government agreement (e.g. Corporate Integrity Agreement, Consent Decree, etc.) is required
  • Demonstrates strong interpersonal skills and ability to influence at all levels of the organization.
  • Ability to manage multiple projects concurrently and collaborate across several functional areas, meeting internal and external deliverables with high degree of accuracy.
  • Highest level of ethics and personal integrity

Curious? Find more information at https://jobs.vibrantm.com.
 Apply here
Posted 7/13/2019

SENIOR MANAGED CARE AND CUSTOMER OPERATIONS COMPLIANCE MANAGER - Genentech, Inc.
Location: South San Francisco, CA

The Sr. MCCO Compliance Manager will support development and oversight of MCCO's compliance efforts. Your primary responsibility is to ensure effective and consistent compliance with relevant laws/regulations and organizational policies and procedures among MCCO personnel.


In this position, you will be primarily accountable for consistently, effectively:

  • Staying abreast of relevant laws, regulations and internal policies and procedures that govern Managed Care & Customer Operations (MCCO) strategies and operations
  • Expertly driving development, implementation and ongoing monitoring of MCCO compliance policies, procedures, practices, objectives and metrics
  • Expertly driving development of communication, education and other tools/resources to enable MCCO to meet or exceed its compliance objectives and metrics
  • Expertly communicating with and educating others across MCCO regarding MCCO compliance objectives, programs, policies, procedures, processes, practices, standards, systems, tools and other resources
  • Modeling compliance for others
  • Supporting or otherwise leading the ongoing development, fine-tuning and enhancements of MCCO compliance processes, systems and other tools. Includes supporting or leading Standard Operating Procedures (SOPs) development or updates and associated communication and education of others
  • Representing MCCO Compliance to other Genentech and Roche compliance, legal and business functions
  • Participating in or otherwise leading various cross-functional or other project teams
  • Establishing and cultivating cross-functional relationships. Working collaboratively with all internal/external partners and stakeholders
  • Ensuring assigned goals and objectives are met or exceeded and that assigned projects and other work are completed on time, to high standards and within budget

In this position, you will:

Strategy/Planning:

  • Act as a point-of-contact to Managed Care & Customer Operations (MCCO) personnel (from the functional leadership team level, e.g., Managed Care Marketing or Account & Channel Management leadership teams to individual contributor level) for questions pertaining to healthcare and related compliance
  • Stay abreast of relevant laws, regulations and internal policies and procedures that govern MCCO strategies and operations
  • Develop and maintain an in-depth understanding of MCCO's business, organization structure, reporting relationships, core business practices, policies and procedures, as these relate to healthcare compliance and ethics
  • Proactively identify trends, dynamics or other factors influencing MCCO's overall healthcare and related compliance to provide input into future MCCO Compliance plans and objectives
  • Evaluate existing and evolving healthcare compliance, ethics and related legislation and regulations and other marketplace/industry dynamics to determine requirements for Genentech policies and policy guidelines
  • Contribute to annual and longer-range MCCO Risk Assessment and Work Plan development and implementation
  • Guide development of policies and Standard Operating Procedures (SOPs) across MCCO
  • Work with teams to identify and recommend new or updated business processes, training and communication, operations, reporting and the like to support policies and policy guidelines implementation
  • Work with teams to author new or amended policies and policy guidelines and distribute for internal partner and stakeholder input
  • Support the design and delivery of internal training and communications on new or amended healthcare, ethics and related compliance policies and policy guidelines
  • Lead or otherwise support development of communication, education and other tools/resources to enable MCCO to meet or exceed its compliance objectives and metrics
  • Ensure the appropriate resources, practices, processes, systems reports and metrics are in place to support timely, effective and efficient pull-through of policies

Participating in or otherwise leading various cross-functional or other special projects Operations:

  • Represent MCCO Compliance to Genentech or Roche compliance or legal functions, and MCCO business functions, as a member of the MCCO extended leadership team
  • Communicate and educate others across MCCO regarding MCCO compliance objectives, programs, policies, procedures, processes, practices, standards, systems, tools and other resources
  • Coordinate all MCCO compliance training and activities across MCCO
  • Provide ongoing compliance guidance as needed or otherwise appropriate
  • Support other MCCO colleagues with MCCO systems/database management, such as corrective action plan data management and follow-up. Includes policy and other critical information/resource updates
  • Assure technologies and processes adhere to compliance policies
  • Assist with other MCCO Compliance duties and/or projects

The successful candidate will demonstrate the following competencies critical to this role:

  • Technical and business expertise - Applies emerging knowledge and trends; builds strong relationships; contributes to expertise within and beyond assigned area
  • Communication - Listens well; expresses ideas fluently and logically; is open to input and can be depended on for truthfulness
  • Teamwork and collaboration - Creates an atmosphere of openness and trust; collaborates; offers support and encouragement
  • Achieving results - Is goal-directed and persistent; is accountable for meeting commitments' recognizes the contributions of peers

Qualifications:

  • Bachelors Degree (life sciences, law, public policy, marketing, business, education, finance/accounting or related discipline preferred)
  • Healthcare Compliance Certification (before or w/in 12 months of appointment)
  • 8 or more years' work experience
  • 4 or more years' work experience in legal, compliance, policy, auditing or training (previous pharmaceutical, biotechnology or related industry experience is preferred)
  • In-depth knowledge of, the legal and regulatory environment, as it relates to healthcare compliance in the pharmaceutical/biotechnology or related industry (includes anti-kickback statutes, government fraud and abuse, off-label promotion, PhRMA Code, etc.)
  • Significant project management, program administration, analytics and reporting experience

Skills/Abilities:

  • Proven track record for consistently meeting or exceeding objectives and goals
  • Strong verbal and written business communication skills: highly adept at synthesizing and summarizing complex and/or voluminous content into clear, concise and actionable communications
  • Good influencing skills: can influence without authority
  • Good business presentation skills: is comfortable and effective when presenting to others
  • Strong business acumen: understands how the business "works" and demonstrates consistently effective "navigation" across the organization
  • Works well within teams
  • Strong process-orientation: has proven effectiveness in identifying, developing and implementing scalable/sustainable process and other continuous improvements to achieve organizational efficiencies and increase effectiveness
  • Proven track record of effective decision-making: makes good business decisions and consistently exercises sound judgment
  • Business travel, by air or car, is required for regular internal and external business meetings
 Apply here
Posted 6/20/2019

SENIOR AUDIT & ANALYTICS MANAGER, CONTRACT SERVICES- E5 - Genentech, Inc.
Location: South San Francisco, CA

Senior Audit & Analytics Managers play a leadership role in assuring Contract Operations full and consistent compliance with business, legal and regulatory requirements that govern contract services and customer partners for all commercial and relevant government programs and contracts. Audit & Analytics Managers perform internal audits and manage external contracted customer and 340B entity audits. In addition, Audit & Analytics Managers gather, analyze, synthesize and provide partners and stakeholders with compliance and audit related-data to support ongoing business operations and decisions, which includes identifying and interpreting trends that emerge from internal and external audits and communicating these findings and implications to partners/stakeholders. Given the nature of their work, Audit & Analytics Managers act as subject matter experts (SMEs) on SPCM Contract Operations processes, collaborating with Contract Operations partners and stakeholders in various meetings, initiatives and projects. The audit responsibilities of this position are critical to ensuring the integrity, accuracy and compliance of Contract Operations processes and activities and external contracted customer compliance. Senior Audit & Analytics Managers are expected to play a leadership role in guiding overall compliance operations and practices across Contract Operations. As such, Senior Audit & Analytics Managers may have one or more direct reports and they also share some of the other departmental management activities with their manager, e.g., reviewing the work of others, representing Contract Operations compliance to cross-functional teams, partners and stakeholders, preparing and delivering senior management presentations on strategic or complex issues, and leading strategic projects.


  • Acts as a lead SME for Contract Operations and customer audit compliance and SOPs
  • Proactively seeks out complex information on changes in laws, regulations and other external factors and dynamics. Works with manager and other internal partners/stakeholders to interpret the information and assess its effect on current Contract Operations systems, processes and practices. Develops appropriate responses, including recommending changes to general and/or auditing and analytics practices to assure Contract Operations' ongoing compliance and accuracy
  • Plays a lead role in development, implementation and ongoing maintenance of Contract Operations SOPs
  • Develops, recommends, implements and educates others on performance metrics for Contract Operations general and audit-specific practices
  • Oversees and ensures timely and targeted development and delivery of Contract Operations Compliance & Analytics training; including conducting training for other staff members and, as appropriate, others outside of the department
  • Leads other project initiatives
  • Serves as the primary point-of-contact for SPCM Contract Operations' compliance and auditing. Includes all compliance-related initiatives and representing Contract Operations' and customer compliance and audit activities to internal and external partners and stakeholders
  • Serves as an expert on all applicable laws, regulations, corporate and business unit standards and requirements and helps drive cross-functional operations to assure compliance, accuracy and achievement of all other key performance metrics for Contract Operations
  • Works with other audit managers and internal process SMEs to ensure proper process controls are in place
  • Oversees or otherwise supports internal and external audits by organizing, compiling and storing necessary data and creating reports and presentation materials
  • Oversees and conducts timely and targeted internal auditing and validation to ensure compliance, as per Contract Operations SOPs and other business, legal and regulatory requirements
  • Partners with 340B field account management teams to provide auditing, analysis, reporting and communication support for 340B Program Integrity
  • Provides expert post-auditing guidance and advice to cross-functional partners and stakeholders and, where applicable, plays a lead role working with SMEs to identify root cause and develop process-driven solutions and corrective action plans
  • Where applicable, closely monitors corrective action plan implementation to assure timely, thorough and compliant follow-through
  • Oversees or otherwise performs analyses and provides reporting to identify trends and interpret data related to Contract Operations and customer compliance and auditing activities
  • Plays the lead role in presenting audit and corresponding analytical findings, insights and recommendations to stakeholders
  • Monitors operations and results in accordance with Contract Operations' performance metrics. Provides and maintains scorecards and scorecard reporting
  • Where applicable, hires, develops and oversees the work of direct reports
  • Complies with all laws, regulations and policies that govern the conduct of GNE activities

Qualifications:

  • Bachelors Degree (general business, finance, or public policy disciplines are preferred)
  • MBA or other related graduate-level degree is a plus
  • A minimum of 8 years' work experience in managed care and/or government programs or related analytics
  • 4 or more years' managed care and/or government contract operations or other related program administration experience in the pharmaceutical/biotechnology or related industry
  • Previous experience effectively leading cross-functional strategy and policy development teams
  • Expert knowledge/understanding of drug contracting, managed care customers, and the distribution channels
  • Thorough knowledge of current policies and guidelines that affect contracts, pricing, rebates, etc. in the managed care environment
  • Thorough knowledge of systems and reporting mechanisms that support contract operations particular to the pharmaceutical/biotechnology or related industry
  • Must demonstrate a high level of proficiency with Microsoft, Excel, PowerPoint and Word
  • Strong working knowledge of relevant pricing and contracting strategy development methodologies and modeling (quantitative and qualitative)
  • Outstanding skills/proven track record in writing departmental SOPs and training others in their use of SOPs
  • Previous experience in other functions within the pharmaceutical, biotechnology or related industry is preferred, e.g., product marketing, managed care marketing, field sales, field account management, market planning, strategic planning, market research, market or sales analytics, customer finance, legal, customer service & operations, etc.
  • Proven track record for consistently meeting or exceeding qualitative, as well as any quantitative, targets and goals
  • Business travel, by air or car, is required for regular internal and external business meetings
 Apply here
Posted 6/20/2019