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EMPLOYMENT OPPORTUNITIES

 

ASSOCIATE MANAGER, ETHICS & COMPLIANCE OPERATIONS - Novo Nordisk
Location: Plainsboro, NJ US


About the Department
At Novo Nordisk, we're committed to building the best Ethics & Compliance team in the pharmaceutical industry. Operating at the highest ethical standards and ensuring adherence to corporate and legal regulations, this team is constantly called upon to design and implement creative solutions to complex issues. From training on new procedures, to auditing against local and corporate policies, to reporting compliance-related issues, Ethics & Compliance keeps us accountable every step of the way as we develop life-changing therapies and bring them to market. At Novo Nordisk, you will be part of a company respected equally for its financial results and its business ethics. Are you ready to make a difference?

The Position
This position manages the execution and supports the development of the Ethics & Compliance (E&C) Department Operations plan and manages strategic department areas within the Operations function (e.g. third party representatives, special projects, etc.). This position also supports and performs special projects aligned with the overall execution of the E&C strategy across functions/organizational lines as requested by E&C management.

Relationships
Reports to the Director, Government Reporting and Operations. Works closely with Ethics & Compliance Leadership (ECLT). Closely collaborates with NNIs in-house legal counsel, leaders across lines of business, and is a member of cross-functional teams throughout Novo Nordisk Inc (NNI). Supports affiliates (e.g. NNCI, NNRC) and Global Service Center in Bangalore. External relationships include vendors, outside counsel, industry peers, and government agencies.

Essential Functions

  • Supports the Director, E&C Strategy & Operations in facilitating and raising awareness of the Ethics & Compliance program while fostering accountability for ethics and compliance throughout the organization
  • Maintains understanding of laws and regulations, enforcement actions and evolving practices relevant to pharmaceutical ethics & compliance and proposes updates to Ethics & Compliance program as appropriate
  • Establishes and maintains the NNI Third Party Representative process (e.g., LDDR responsibilities) in collaboration with the global teams. Also manages the Ineligible Persons review, including updating and maintenance of processes and procedures for identifying Novo Nordisk employees, consultants, and vendors (i.e., Covered Persons, Ineligible Persons) while understanding local and global impact
  • Actively works to identify, analyze, and mitigate potential business ethics risks to the organization
  • Informs management of ethics & compliance issues in a timely manner, while encouraging the flow of information between colleagues and lines of business
  • Monitors and updates Third Party Representative Policy and associated policies
  • Plans and executes special projects in support of department initiatives
  • Provides direction to the GBS Bangalore Compliance team as appropriate
  • Provides support to the US affiliates and NNCI
  • Assigned special projects as part of the E&C operations function
  • Additional responsibilities with department or operational impact as assigned

Physical Requirements
0-10% overnight travel required.

Qualifications

  • A Bachelor's degree from an accredited institution required, additional education/certification within the compliance and healthcare related fields is preferred
  • A minimum of 6 years combined pharmaceutical, legal, regulatory, and compliance experience required OR a minimum of 4 years' experience required if accompanied by an advanced degree or certification (e.g. MBA, JD, PMP)
  • Experience working under a Corporate Integrity Agreement (CIA) is preferred
  • Demonstrated knowledge and understanding of the Anti-Kickback Statute, the False Claims Act, Food & Drug Administration (FDA) rules and regulations regarding the promotion of pharmaceuticals, government corporate integrity agreements and/or other prosecution agreements with other pharmaceutical companies, PhRMA and federal and state aggregate spend reporting requirements required the current activities and developments involving pharmaceutical sales and marketing
  • Ability to drive multiple projects to completion meeting internal and external deliverables with high degree of accuracy
  • Project management experience preferred
  • Uncompromising ethics and high standard of personal integrity
  • The ability to work proactively and independently with minimal supervision
  • Excellent communication and organization skills
  • The ability to think objectively and use sound reasoning principles
  • Builds and maintains strategic relations with internal and external stakeholders

Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

 Apply here
Posted 1/18/2021

ASSOCIATE DIRECTOR, RISK, ANALYTICS AND OPERATIONAL EXCELLENCE - AbbVie
Location: Lake County, IL US


I. POSITION SUMMARY:

Job Description:

The role will report directly to the Office of Ethics & Compliance (OEC) Director of Risk, Analytics and Operational Excellence. Broadly, the Associate Director will be responsible for advancing AbbVie's Global OEC risk, analytics, and operational excellence program which includes: Enhancing and evolving the OEC risk assessment strategy; Designing and executing on a sustainable operations model that drives towards an analytics-enabled, progressive risk management and operational excellence approach; Developing a framework to implement and manage the analytics program consistently across the global organization; Executing on the Operational Excellence framework to support strategic, continuous process improvement across the OEC; Serving as a liaison and expert to key stakeholders across the globe to implement our risk, analytics and operational excellence framework; Performing trending and data analytics in support of an iterative risk, analytics and operational excellence process; and Identifying valuable compliance insights, trends and information to inform OEC and business decisions.

II. PRIMARY JOB RESPONSIBILITIES:

  • Developing and executing on a progressive strategy for and conducting internal risk assessments procedures including interviews of key stakeholders, application of industry trends, data analysis and collaboration with other OEC and functional divisions to understand overall business risks and challenges within the business and other OEC groups.
  • Identifying and assessing existing and emerging business practices for potential areas of compliance vulnerability and risk; developing a global methodology for continuous and proactive compliance risk assessment.
  • Working with relevant stakeholders to identify operational excellence imperatives and priorities, mitigate identified risks and meet government, industry and company OEC requirements.
  • Manage operational excellence projects to embed OEC process and controls while determining ownership of mitigation activities - identifying overlapping responsibilities, supporting the integration of risk assessment results into tailored monitoring plans and applying an iterative analytics-enabled strategy to proactively manage risks.
  • Identifying, delivering and presenting risk assessment results, analytics and trends to leadership with proactive recommendations prioritizing and addressing the issues through various mitigation channels.
  • Implementing, managing and evolving the OEC Analytics Platform - collaborating with internal and external stakeholders to deliver and operate analytics globally.
  • Proactively making recommendations on developing and assessing corporate OEC programs, training, adherence and effectiveness based on risk and analytics observations.
  • Provide ongoing, real time OEC advisory support for the business and support functions across the organization.
  • Supporting innovation and driving efficiencies and consistency in our approach to OEC risk, analytics and operational excellence while supporting other global OEC initiatives and Operational activities (e.g., compliance monitoring).

III. ADDITIONAL JOB RESPONSIBILITIES:

  • Interface with Business Compliance, Business (Sales, Marketing, R&D, Medical) personnel, Support Functions (Legal, HR, Finance, IT) and Senior and Executive Management
  • Manage and oversee multiple complex projects
  • Manage team of direct and indirect reports by carrying out supervisory responsibilities
  • Proactively produce reports, presentation, materials, guidelines and documents
  • Deliver updates to Leadership, as required

IV. POSITION QUALIFICATIONS:

Education:

Bachelor's Degree required, advanced degree a plus.

Experience:
8 - 10 years Compliance or transferable pharmaceutical and life sciences industry experience

Knowledge, Skills, and Abilities

  • Excellent interpersonal, verbal and written communication skills, including adjusting content and style for various audiences.
  • Ability to successfully influence multiple stakeholders and lead cross-functional teams, driving results.
  • Strong organizational, analytical, project management and team building skills.
  • Ability to prioritize, schedule and manage multiple, complex projects.
  • Ability to develop, set and adjust strategic goals in the face of continuously evolving risk landscape.
  • Change agile - Ability to be flexible and adjust strategy based on the evolving business.
  • Inquisitive and open minded - Ability to learn, understand and guide without bias in order to bring the best solution or alternatives that supports an efficient and effective Compliance program
  • Working knowledge of MS Word, Visio, Power Point, Excel, Access, and Outlook.
  • Deep experience with analytics tools (e.g., Tableau, PowerBI, Qlik), systems and structures that facilitate an efficient and effective compliance program.
  • In-depth understanding of business objectives and strategies and how those translate to OEC priorities in order to advise and partner with the business
  • Good understanding Pharmaceutical and Medical Device commercial operations and the laws, regulations and guidance applicable to the industry (e.g., Food, Drug and Cosmetic Act and of the roles and authority of government agencies and industry partners, PhRMA, FDA, OIG, PDMA, Affordable Care Act, PDMA, ACCME, etc.).

 Apply here
Posted 12/22/2020

COMPLIANCE OPERATIONS MANAGER - Exelixis
Location: Alameda, CA US
Salary Grade: 9
Division: General & Administrative
Department: Healthcare Compliance
FLSA Status: Exempt
Reports To: Associate Dir, Healthcare Compliance
Effective Date: January 2021


SUMMARY: The Compliance Operations Manager will support the development, implementation, and continuous improvement of healthcare compliance practices, systems, and processes, with an emphasis on business integrity, operational excellence, and practicality. One primary responsibility will be assisting in the management of the process for tracking and reporting HCP spend, including assessing global transparency reporting requirements. This position will also evaluate materials submitted for review and approval, perform audits, and conduct training related to interactions with the healthcare community. Of similar priority will be supporting the Company's healthcare compliance monitoring program. The essential business partners for this function are corresponding positions in Commercial, Development, Medical Affairs, IT, Legal, and Finance.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Works on a range of departmental and/or strategic problems where analysis of situations or data requires critical thinking, an in-depth evaluation, and company knowledge of various factors. May also be required to manage external consultant engagements, when needed, including overall budgets, schedules, and performance standards.
  • Supports processes related to fulfillment of the company's HCP spend tracking and reporting obligations under the ACA's Sunshine Act provisions and related state laws regulating HCP spend by drug manufacturers or requiring state tracking and reporting.
  • Applies technical expertise in the arena of data analytics and supports goals with an understanding of priority and impact to the HCP spend tracking and reporting program, compliance department and organization.
  • Collaborates with Legal colleagues on global transparency reporting requirements to determine applicability to Exelixis business activities and supports building of infrastructure to enable compliance with those requirements as the company continues to grow and advance its pipeline.
  • Participates in industry workgroups, remaining current on new and proposed reporting laws and regulations and supports operationalization of new or enhanced processes to enable compliance.
  • Supports execution of the audit and monitoring program, including development and application of tools, performance standards, and completion of corrective action.
  • Leverages data analytic skills proactively to address potential healthcare compliance issues and thereby prevent or minimize compliance risk to the company. Works with internal stakeholders to achieve business goals within a compliance framework.
  • Regularly reviews reports of new compliance developments from governmental agencies such as the OIG and state agencies, including fraud alerts, special advisories or proposed rules and, in conjunction with the legal department, to ensure appropriate interpretation and training regarding such developments.

SUPERVISORY RESPONSIBILITIES:

  • None

EDUCATION/EXPERIENCE/SKILLS:
Education:

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

Experience:

  • Healthcare compliance auditing and monitoring experience required. Finance audit experience is a plus.
  • Experience with global transparency reporting requirements required.
  • 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 SteepRock HCP engagement system, Veeva, and 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 25%

JOB COMPLEXITY:

  • Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
  • Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation of criteria for obtaining results.
  • Uses professional concepts and company policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
  • Networks with key contacts outside own area of expertise.

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 12/19/2020

SR. TO EXEC. DIRECTOR, COMPLIANCE LEAD, DERMATOLOGY FRANCHISE - Incyte
Location: Wilmington, DE US


Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.

The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.

Job Summary(Primary function)
This position will include management and oversight of Incyte's newly formed US Dermatology Franchise and is intended to have a Compliance Program consistent with Incyte's US Compliance Policies, Procedures and Compliance framework. The position will require having significant interaction with Incyte's Dermatology Sales and Marketing, Legal, Regulatory, Public Affairs, Patient Advocacy, Medical Affairs, Product Strategy and other company departments. This position will work to continuously enhance Incyte's Compliance program based on the legal enforcement environment in the US through application of best practices in the life sciences Compliance space. This position reports to the Chief Compliance Officer.

Essential Functions of the Job (Key responsibilities)

  • Work with the Chief Compliance Officer (CCO) to define and provide strategic direction for the U.S. Compliance function across all compliance program elements leveraging knowledge of industry best practices in compliance and 'best fit' mentality.
  • Work with the CCO and US business stakeholders to prepare an annual compliance work plan based upon a comprehensive, annual compliance risk assessment.
  • Proactively plan for emerging trends in U.S. compliance, anticipate the impact on processes, and work with business stakeholders to determine how to address them using the most up to date information around emerging state and federal laws, U.S. government enforcement actions, evaluation of Corporate Integrity Agreements, etc.
  • Partner with the U.S. Dermatology Business to maintain an infrastructure that supports a company culture of compliance and recognizes that compliance is a collective responsibility of the all company employees.
    • Lead efforts to understand current and future compliance needs of business partners.
    • Conduct routine meetings with key business leaders in the Commercial and Medical space.
    • Develop tools, processes and reports to support the business's ownership of Compliance.
    • Manage and lead the quarterly U.S. Compliance Committee.
  • Maintain a current working knowledge of various laws, regulations, and industry guidance that affect the corporate-wide compliance program, including federal and state government price reporting laws, state and federal privacy laws including GDPR, OIG and DOJ guidelines, PhRMA code and state marketing compliance laws.
  • Provide guidance to the U.S. Dermatology Business and integrate compliance controls into the scope of existing business practices where applicable.
  • Lead the U.S. or Dermatology Franchise Compliance Committee, as applicable, and provide regular updates and reports to the CCO, the Global Compliance Committee, and senior and executive management on the operation and progress of US compliance efforts and initiatives, audit findings, investigation outcomes, project status updates, as well as potential risks and proposed solutions.
  • Support the Global Investigations function in conducting compliance investigations involving potential violations of compliance policies, laws or regulations and oversee corrective action.
  • Work with Internal Audit to provide input on annual audit plans relates to activities for the Dermatology Franchise and work with the business to timely complete corrective action plans.
  • Work with Global Compliance Risk Assessment to complete implementation of Incyte's Risk Assessment process and assist Dermatology business partners with ongoing updates of the Risk Assessment.
  • Partner with Legal and the internal Compliance Policy/Training function to identify training needs, develop an annual training plan, create relevant training content and conduct effective training.
  • Partner with Legal and internal Compliance Policy/Training to identify Policy/guideline needs, develop/enhance policies and guidance documents and ensure optimal accessibility for the U.S. Business using the most up to date technology.
  • Partner with Global Monitoring to create a monitoring plan and execute against that plan.
  • Support creation of a high-performing team environment that fosters growth and development through on-going coaching and mentoring.

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

  • Bachelor's degree required and Law degree or other advanced degree preferred.
  • 12 or more years of pharmaceutical company compliance experience, preferably with a company working in dermatology or a related field.
  • Proven record of accomplishment in the areas of US compliance best practices.
  • Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry.
  • Effective public speaking skills and an ability to communicate in both verbal and written form with multiple stakeholders within and outside the company.
  • Ability to lead and work effectively with cross functional teams and projects.
  • Strategic leadership capability, strong organizational awareness, sound judgment, strong business acumen and ability to make decisions with the input of appropriate input from multiple stakeholders.
  • Strong problem solving and risk analysis skills.
  • Ability to effectively prioritize and work in a fast-paced environment and to handle multiple complex and confidential tasks.
  • Ability to travel as necessary

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

 Apply here
Posted 12/8/2020

DIRECTOR, MONITORING, AUDITING & RISK MANAGEMENT - Insmed
Location: Bridgewater NJ, US


COMPANY DESCRIPTION
About Insmed:
Insmed is a growing global biopharmaceutical company powered by our purpose to deliver life-altering therapies to small patient populations experiencing big health problems. Our most valuable resource is our employees, and a patients-first mentality guides everything we do. Today, we are building a world-class team of talented individuals who are willing to challenge the status quo, solve problems, and work collaboratively and with a sense of urgency.

Come join us if you are ready to roll up your sleeves and be recognized for your efforts while working alongside team members who share your passion for serving patients and their families.

OVERVIEW
About the Role:

Reporting directly to the VP of Corporate & Healthcare Compliance, this role will serve as the lead for the Healthcare Compliance Auditing, Monitoring and Risk Management team. The incumbent will guide and direct healthcare compliance auditing and monitoring life cycle, from conducting risk assessment through creation of the annual monitoring and auditing plan through conduct of those activities and creating and assessing results and metrics. This role will be based at our Bridgewater, New Jersey headquarters location, and remote candidates may be considered.

Responsibilities
Additional representative responsibilities will include, but not necessarily be limited to, the following:

  • Manage global program for compliance risk assessment and management (including development of best practices and guidelines)
  • Support and coordinate compliance risk assessment efforts globally, in partnership with regional Compliance Officers
  • Conduct healthcare compliance monitoring include live activities in the US (e.g. field rides, speaker programs, congresses) and records review globally (e.g. travel & expense, healthcare professional engagements)
  • Conduct healthcare compliance audits in the US (e.g. patient services, speaker's bureau) and pertaining to global functions (e.g. grants, medical information, publications)
  • Track remediation for all activities
  • Capture and report metrics in a meaningful and engaging manner that helps the Global Compliance Leadership Team and other senior leaders understand Insmed's global compliance risk profile
  • Lead Enterprise Risk Management activities (assessment, plan, oversight) in conjunction with Insmed's Operating Committee
  • Create and facilitate presentation to mid-level and senior-level management (e.g. Healthcare Compliance Committee, US Leadership team, etc.)
  • Manage individual contributor direct report by providing coaching, development and guidance

QUALIFICATIONS
About You:

  • Bachelor's degree required; advanced degree preferred
  • Compliance certification and auditing certification are a plus
  • At least 10 years' experience in corporate compliance for a pharmaceutical or biotech company
  • Knowledge of US and global compliance regulations, laws and standards
  • Experience working globally (EMEA, Japan/APAC)
  • Experience in conducting healthcare compliance risk assessments
  • Experience in managing enterprise risk management
  • Experience in conducting healthcare compliance monitoring (live field rides, live speaker programs, records reviews)
  • Experience in conducting healthcare compliance audits
  • Experience in continuous improvement for compliance programs
  • Involvement in creating and presenting presentations for mid-level and senior-level management
  • Involvement in leading and guiding compliance risk assessment, auditing and monitoring strategy
  • Must have excellent communication skills (verbal and written).
  • Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
  • Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).

ADDITIONAL INFORMATION
Travel Requirements:

  • Domestic and/or International travel required (5-10%)

Insmed is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability or any other characteristics protected by applicable federal, state or local law.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Please note that we review every submission and we will keep all submissions on file for six months. Insmed is an Equal Opportunity Employer.

 Apply here
Posted 12/8/2020

MANAGER - ETHICS & COMPLIANCE OPERATIONS - Novo Nordisk
Location: Plainsboro, NJ, US


About the Department
At Novo Nordisk, we're committed to building the best Ethics, Compliance and Privacy (ECP) team in the pharmaceutical industry. Operating at the highest ethical standards and ensuring adherence to corporate and legal regulations, this team is constantly called upon to design and implement creative solutions to complex issues. From training on new procedures, to auditing against local and corporate policies, to reporting compliance-related issues, ECP keeps us accountable every step of the way as we develop life-changing therapies and bring them to market. At Novo Nordisk, you will be part of a company respected equally for its financial results and its business ethics. Are you ready to make a difference?

The Position
This position manages and supports the development of the Ethics, Compliance & Privacy (ECP) Department operational plan. The position manages key activities that support the entire department, including driving the Issue Management function, supporting operational technology projects, and other projects and responsibilities aligned to the operational plan and department strategy. This position also leads projects aligned with the overall execution of the ECP strategy across functions and organizational lines as requested by department leadership.

Relationships
Relationships Reports to the Director, Ethics, Compliance & Privacy (ECP) Strategy & Operations. Works closely with Ethics & Compliance Leadership (ECLT). Closely collaborates with NNI's in-house legal counsel and leaders across lines of business. Supports affiliates (e.g. NNCI, NNRC, USPS), global teams (e.g. BECO), and Global Business Support in Bangalore. External relationships include vendors, outside counsel, industry peers, and government agencies.

Essential Functions

  • Supports the Director, Ethics, Compliance & Privacy Strategy & Operations in facilitating and raising awareness of the Ethics & Compliance program, fostering a culture of ethics & compliance throughout Novo Nordisk Inc (NNI)
  • Develops and leads the processes and systems related to issue management, including triage, tracking, mitigation, and close-out; as well as associated process development, improvement, automation, and technology projects
  • Leads special projects and project teams as part of the E&C operations function, aligned to departmental strategy, initiatives, and/or risk response
  • Identifies, leads, and executes Operational projects, including leading project teams consisting of Operations and cross-functional employees
  • Maintains understanding of laws and regulations, enforcement actions and evolving practices relevant to pharmaceutical ethics & compliance and proposes updates to Ethics & Compliance program as appropriate
  • Actively works to identify, analyze, and mitigate potential business ethics risks to the organization
  • Informs management of ethics & compliance issues in a timely manner, while encouraging the flow of information between colleagues and lines of business
  • Provides support to North American affiliates
  • Additional responsibilities with department or operational impact as assigned

Physical Requirements

  • 0-10% overnight travel required.

Qualifications

  • A Bachelor's degree from an accredited institution required, additional education/certification within the compliance and healthcare related fields is preferred
  • A minimum of 8 years combined pharmaceutical, legal, regulatory, and compliance experience required OR a minimum of 6 years' experience required if accompanied by an advanced degree or certification (e.g. MBA, JD, PMP)
  • Experience working under a government agreement (e.g., CIA, DPA, Consent Decree) preferred
  • Demonstrated knowledge and understanding of the Anti-Kickback Statute, the False Claims Act, Food & Drug Administration (FDA) rules and regulations regarding the promotion of pharmaceuticals, government corporate integrity agreements and/or other prosecution agreements with other pharmaceutical companies, PhRMA and federal and state aggregate spend reporting requirements required
  • Ability to drive multiple projects to completion meeting internal and external deliverables with high degree of accuracy
  • Uncompromising ethics and high standard of personal integrity
  • Ability to work proactively and independently with minimal supervision
  • Excellent communication and organization skills
  • Ability to think objectively and use sound reasoning principles
  • Builds and maintains strategic relations with internal and external stakeholders
  • Project management and cross-functional project leadership experience preferred
  • Experience with metrics and/or dashboard development and associated systems (e.g., Tableau, Qlik) is a plus
  • Experience establishing and enhancing cross-functional processes
  • Advanced proficiency in Microsoft Office suite required

Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

 Apply here
Posted 12/1/2020

SENIOR MANAGER - GOVERNMENT ACCOUNTABILITY - Novo Nordisk
Location: Plainsboro, NJ, US


About the Department
At Novo Nordisk, we're committed to building the best Ethics & Compliance team in the pharmaceutical industry. Operating at the highest ethical standards and ensuring adherence to corporate and legal regulations, this team is constantly called upon to design and implement creative solutions to complex issues. From training on new procedures, to auditing against local and corporate policies, to reporting compliance-related issues, Ethics & Compliance keeps us accountable every step of the way as we develop life-changing therapies and bring them to market. At Novo Nordisk, you will be part of a company respected equally for its financial results and its business ethics. Are you ready to make a difference?

The Position
The position is responsible for managing daily operational activities related to the Ethics & Compliance (E&C) Departments government reporting obligations including but not limited to Transparency Reporting (e.g. local, state, federal requirements for transfers of value, price reporting, disclosure requirements, sharp/drug takebacks), Novo Nordisk Inc (NNI) government agreements (e.g. Corporate Integrity Agreement (CIA)) regulatory requirements (e.g. PDMA reporting) and the systems that support these processes (e.g. TRAC).

Relationships
Relationships This position reports to the Director E&C Government Accountability, and Frequently interacts with other E&C functional areas (e.g. BPs, Education). Regularly interacts, and provides direction to, information technology, Commercial Effectiveness, Clinical Operations and Marketing Effectiveness. Collaborates with Legal for assumptions and opinions. Manages external customers including Health Care Professionals (HCP), third party/external vendors, and external consultants. Interacts with government officials. Provides direction to NNIs Global Servicing Center in Bangalore. Supports North America and serves on global projects. Serves on technical and other subcommittees (e.g. Change Advisory Board (CAB)).

Essential Functions

  • Supports the Director - E&C Government Accountability in facilitating and raising awareness while fostering accountability for Ethics & Compliance program throughout the organization
  • Maintains understanding of laws and regulations, enforcement actions and evolving practices relevant to pharmaceutical ethics & compliance and proposes updates to Ethics & Compliance program, as appropriate
  • Informs management of ethics & compliance issues in a timely manner while encouraging the flow of information between colleagues and lines of business. Actively works to identify, analyze, and mitigate potential business ethics and other risks to the organization
  • Manages the review and timely reporting of all government requirements while understanding local and global impact
  • Supports the Director in the development of the annual plan to meet NNIs government obligations including but not limited to local, state and federal transparency requirements, sharp/drug takeback requirements, price reporting disclosures, PDMA requirements and any NNI specific government agreements
  • Manages creation and continued maintenance of government reporting protocols and assumption documents to support accurate filings and internal documentation
  • Responsible for supporting government attestations and the transactional and systems work that supports these attestations (e.g. data review)
  • Forwards risks and issues to appropriate E&C and line of Business (LoB) teams in a timely manner
  • Creates comprehensive mitigation and remediation plans in conjunction with E&C risk team to ensure correct strategies are in place to continually improve processes and data integrity
  • Supports NN affiliates (e.g., NNCI) with implementing and maintaining a government accountability program
  • Responsible for creating and executing an Organizational Change Management (OCM) Plan for Government Accountability Programs, as needed
  • Conducts training to employees and third-party vendors to timely communicate new government reporting requirements or updated NNI interpretations
  • Supports the government accountability budget (e.g. forecasting expenditures, reporting variances, and ensuring responsible spending)
  • Responsible for ensuring that Compliance senior management is informed of compliance issues in a timely manner and encourages the flow of information between Compliance colleagues and lines of business
  • Additional responsibilities with government reporting or departmental operational impact as assigned
  • Supports Director with NN A/S collaborations regarding government reporting requirements and integration of systems/data
  • Point of contact for systems updates, upgrades and recommendations from LoB
  • Recommends enhancements to systems, processes and technologies for government reporting
  • Represents E&C on Change Advisory Boards and/or other systems boards as requested

Physical Requirements

  • 0-10% overnight travel required.

Qualifications

  • A Bachelor's degree from an accredited institution required
  • A minimum of 8 years combined pharmaceutical, legal, regulatory, and compliance experience required OR a minimum of 6 years' experience required if accompanied by an advanced degree or certificate (MBA, JD, PMP, etc.)
  • Demonstrates functional knowledge and understanding of the Anti-kickback Statute, the False Claims Act, Food & Drug Administration (FDA) rules and regulations regarding the promotion of pharmaceuticals, government corporate integrity agreements, PhRMA and federal and state aggregate spend reporting requirements
  • Experience working under a government agreement is required (e.g. CIA, DPA, Consent Decree)
  • Demonstrates strong interpersonal skills and ability to influence at all levels of the organization
  • Excellent communication and organization skills
  • Excellent project management skills to oversee and drive project execution
  • Ability to manage multiple projects concurrently and collaborate across several functional areas
  • The ability to think objectively and use sound reasoning principles
  • Knowledge and experience with pharmaceutical aggregate spend solutions and data associated with promotional and clinical data, preferred
  • Ability to manage multiple projects to completion meeting internal and external deliverables with high degree of accuracy
  • Excellent communication skills (written and verbal), strong report writing skills and organization skills are required
  • Supervisory experience preferred

Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

 Apply here
Posted 12/1/2020