The Pharmaceutical Compliance Forum

Employment

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EMPLOYMENT OPPORTUNITIES

 

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


 

DIRECTOR/COMPLIANCE COUNSEL - Heron Therapeutics

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

ESSENTIAL DUTIES & RESPONSIBILITIES:

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

REQUIREMENTS:

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

EOE

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

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


 

MANAGER/SENIOR MANAGER COMPLIANCE GENERALIST - United Therapeutics Corporation

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

Key Accountabilities / Responsibilities:

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

Minimum Requirements:

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

Preferred Knowledge, Skills, and Abilities:

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

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

  Apply here
Posted 9/22/2017


 

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


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

Key Accountabilities / Responsibilities:

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

Minimum Requirements:

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

Preferred Knowledge, Skills, and Abilities:

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

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

  Apply here
Posted 9/22/2017