The Pharmaceutical Compliance Forum

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EMPLOYMENT OPPORTUNITIES

 

DIRECTOR/COMPLIANCE COUNSEL - Heron Pharmaceuticals


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
  • Location: San Diego, CA

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.

 Apply here
Posted 7/13/2018

COMPLIANCE SPECIALIST - Endo
Function: Compliance
Location(s): Malvern, PA
Department: Corporate Compliance & Business Practices
Reports to (title): Compliance Officer, Compliance Operations


Job Summary - a concise overview of the job
Works in Compliance Operations to execute ongoing compliance monitoring initiatives across the company. Monitors promotional and non-promotional activities, including conducting live monitoring and transactional reviews. Makes recommendations and contributes to the development of compliance plan architecture, tools, and programs based on findings and ongoing assessment of risk.

Will focus on identifying, developing, and executing monitoring test plans for emerging risk areas as well as seeking ways to improve and automate existing manual monitoring efforts.

All incumbents are responsible for following applicable Division & Company policies and procedures.
SCOPE OF AUTHORITY - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

COMPLIANCE OPERATIONS

KEY ACCOUNTABILITIES - key outcomes/deliverables, the major responsibilities, and % of time

Accountability     Responsibilities     % of Time
Monitoring

  • Assess and independently monitor the compliance of promotional and non-promotional business activities, including conducting live monitoring and leading transactional reviews.
  • Assess system generated reports to independently monitor the compliance of the business with policies for identifying and reporting contractors and third-parties who are Covered Persons under Endo's CIA to ensure they are properly screened and trained.
  • Support investigation activities.
    ______________________________________________________________________________________________
          35%
Records Reviews

  • Assist in the record review processes for transactional monitoring, including collaborating cross-functionally to identify and gather relevant supporting records, conducting records review to assess compliance with policies/procedures and escalating concerns as appropriate.
  • Collaborate cross-functionally to identify and gather relevant supporting documentation required for the purpose of internal and external reviews.
  • Serve as Compliance knowledge expert on Endo's CIA Covered Persons Process; provide training to Business Partners on identifying Covered Persons and understanding requirements developed by the company to meet the requirements of the CIA.
    ______________________________________________________________________________________________
          35%
Data Analytics, Reporting and Collaboration

  • Collaborate with Compliance organization and relevant business stakeholders to identify areas of risk, monitoring opportunities and areas of improvement for Compliance and/or operational activities such as enhancements to policies/procedures, processes, training or technology.
  • Accurately and completely document monitoring results and findings, gather supporting information and prepare dashboards of key trends and findings from these activities for communication to Business Unit Compliance Officers and/or relevant management.
  • Provide ad hoc support to Associate Director, Communications and Compliance Training and Manager, Aggregate Spend
  • Create Compliance Scorecards for all Business Units in collaboration with Business Office Compliance Officers.
  • Co-manage CIA Annual Report to the OIG as well as creation of supporting documentation.
  • Help to support Independent Review Organization (IRO) review mandated by CIA.
  • Active, productive and collaborative member of Compliance Department who works well across functions, lines of business and geographies.
    ______________________________________________________________________________________________
          $30%
QUALIFICATIONS
Education & Experience


Minimal acceptable level of education, work experience and certifications required for the job

  • BA degree is required.
  • A minimum of 5 years of compliance, audit, finance, accounting, legal or other business function experience required; preferably pharmaceutical/device/healthcare.
  • Experience with use of analytical tools for data analysis.
    ______________________________________________________________________________________________
Knowledge


Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

  • Working knowledge of various laws, regulations, and industry guidance that affect Endo's compliance program, including federal and state government price reporting laws, fraud and abuse and anti-kickback statutes, PDMA, OIG and PhRMA guidelines, state and federal aggregate spend reporting laws and corporate integrity agreements.
    ______________________________________________________________________________________________
Skills & Abilities


Often referred to as "competencies", leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific
e.g. coaching, negotiation, calibration, technical writing etc.

  • Strong attention to detail and business acumen.
  • Experience managing projects with the ability to manage multiple projects/assignments concurrently and demonstrated project management skills with strong interpersonal skills.
    ______________________________________________________________________________________________
Physical Requirements


Physical & mental requirements
e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

  • Ability to travel up to 20% of time.
    ______________________________________________________________________________________________

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 6/14/2018

ASSOCIATE DIRECTOR, OFFICE OF BUSINESS INTEGRITY AND ETHICS - Vertex
Office of Business Integrity and Ethics
Boston, MA
Full-Time


Job Description
As part of the transformation and growth of its world-class compliance program, Vertex Pharmaceuticals is seeking an experienced candidate to join its Office of Business Integrity and Ethics (OBIE) team. OBIE serves as the primary contact for Vertex employees, shareholders, business partners, patients and the general public on issues relating to the implementation of and compliance with Vertex's Code of Conduct globally. The Office is accountable for supervising, coordinating and continuously improving Vertex's Compliance Program ("Program"). This includes defining compliance standards via policies and procedures, compliance training and communications, auditing and monitoring, facilitating internal reporting, compliance-related investigations, and keeping the Executive Committee and the Audit Committee of the Board of Directors informed on compliance matters.

Reporting directly to the Head of Global Assurance, the Associate Director will assist in further enhancing our anti-corruption/anti-bribery compliance program, including but not limited to: third party risk management, training, risk assessments, monitoring and auditing. The Associate Director must have deep knowledge of the Foreign Corrupt Practices Act, the UK Bribery Act and individual country anti-bribery/anti-corruption laws and extensive experience working with or for biotechnology/pharmaceutical companies on these issues. Additionally, the Associate Director will work collaboratively and strategically with colleagues in OBIE, Legal and the business to drive a culture of ethics and integrity across Vertex's global organization. Be a key member of this dynamic team.

In particular, the Associate Director will be responsible for the timely execution of OBIE's global audit plan, which includes audits of affiliates, third parties, and business functions. The Associate Director will manage audit engagements with external consultants, as well as lead audits on his/her own. When leading audits on his/her own, the Associate Director will be responsible for preparing audit notifications, scoping audits, drafting quality and timely audit reports, sharing audit results with business partners, recommending corrective actions, and ensuring completion of same. The Associate Director will be responsible for identifying and tracking themes and trends across various audits. The Associate Director will also assist in driving OBIE's third party risk management initiatives, including anti-corruption/anti-bribery and data privacy related due diligence on third parties, third party training, and third party related assurance activities.

Responsibilities:

  • Maintain and execute an annual, global compliance auditing plan.
  • Design and implement enhancements to anti-corruption and anti-bribery-focused monitoring and auditing.
  • Manage annual risk assessments.
  • Develop and maintain strong relationships with Internal Audit, Corporate Legal, as well as colleagues in other functional areas both in and outside of the U.S.
  • Assist with third party risk management initiatives with a particular focus on corruption/bribery and data privacy risk.
  • Maintain high level of knowledge of current and emerging laws and regulations and recent enforcement actions and inform and educate business units with tailored communications.

Minimum Qualifications:

  • Bachelor's degree.
  • A minimum of 7 years working for or in the biotechnology/pharmaceutical industry.
  • Knowledge of laws and regulations relating to prescription pharmaceuticals, specifically FCPA, UK Bribery Act and country-specific anti-bribery/anti-corruption laws.
  • Strong oral and written communication and influencing skills.
  • Strong analytical, organizational, problem solving skills.
  • Excellent project management skills with the ability to manage multiple priorities simultaneously.
  • Ability to communicate with all levels of management and employees, both in writing and verbally.
  • Self-starter with demonstrated leadership skills and ability to meet goals given limited supervision; able to exercise sound judgment in resolving matters of moderate complexity or escalating matters appropriately.
  • Demonstrated superior ability to identify areas for improvement in controls, systems and processes and implement effective solutions.
  • Ability to work with large amounts of data to analyze information while still seeing the "big picture".
  • Confidence and professionalism to handle difficult conversations and discretion on sensitive matters.
  • Demonstrated strong commitment to compliance, ethics and accountability.
  • Proficiency in MS Office (especially PPT and Excel).
  • Flexibility to work in a fast paced and dynamic work environment.
  • Strong work ethic and positive attitude.
  • Displays confidence and professionalism.
  • Ability to travel approximately 30% of time.

Preferred Qualifications:

  • Juris Doctorate and a minimum of 5 years working at a large, global law firm; or accounting/forensics background and a minimum of 5 years working at a large, global accounting firm.
  • Fluency in additional language(s).
  • Experience working across multiple countries.

Company Information
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases.

Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and offices around the world. For several consecutive years, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the Company, please visit www.vrtx.com.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.

 Apply here
Posted 5/16/2018

SENIOR MANAGER, COMPLIANCE MONITORING - Endo
Location(s): Malvern, PA
Department: Corporate Compliance & Business Practices
Reports to (title): Compliance Officer, Operations


Job Summary - a concise overview of the job
Works within Compliance Operations to implement and manage ongoing compliance monitoring initiatives across the company. Coordinates efforts to monitor promotional and non-promotional activities, including conducting live monitoring and transactional reviews. Executes business process assessments around Compliance related functions. Serves as a subject matter expert and provides analyses of key activities, processes and policies/procedures to maintain and improve Endo's controls.

This role will oversee two direct reports as well as vendor(s) supporting monitoring efforts. The role will also be responsible for overseeing and completing monitoring activities required by the Company's Corporate Integrity Agreement while providing thought leadership to shape the vision of the Company's future monitoring and data analytics program.

All incumbents are responsible for following applicable Division & Company policies and procedures.
SCOPE OF AUTHORITY - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

KEY ACCOUNTABILITIES - key outcomes/deliverables, the major responsibilities, and % of time

Accountability     Responsibilities     % of Time
Live Monitoring

  • Assess and monitor promotional and non-promotional business activities, including conducting live monitoring and leading transactional reviews.
  • Oversee work of vendor assisting in this space.
    ______________________________________________________________________________________________
          20%
Records Reviews

  • Manage the record review processes for transactional monitoring, including collaborating cross-functionally to identify and gather relevant supporting records, conducting records reviews to assess compliance with policies/procedures and escalating potential concerns.
    ______________________________________________________________________________________________
          35%
Business Process Assessments

  • Conduct business process assessments on a regular schedule and prepare the results of any monitoring or auditing activities for presentation to Business Unit Compliance Officers and Executive Management with accountability for compliance in the Company.
    ______________________________________________________________________________________________
          $20%
Data Analytics, Reporting and Collaboration

  • Accurately and completely document monitoring and auditing results and findings, gather supporting information and prepare dashboards of key trends and findings for communication to Compliance Officers and/or relevant management.
  • Serve as a compliance subject matter expert on external regulations and internal processes, policies and procedures relevant to identified areas of monitoring and auditing.
  • Collaborate with others in the Compliance organization and relevant business stakeholders to identify areas of risk, monitoring opportunities and areas of improvement for Compliance and/or operational activities such as enhancements to policies/procedures, processes, training or technology.
  • Active, productive and collaborative member of Compliance Department who works well across functions, lines of business and geographies.
    ______________________________________________________________________________________________
          $25%
QUALIFICATIONS
Education & Experience


Minimal acceptable level of education, work experience and certifications required for the job
  • BA required, advanced degree or applicable certifications preferred.
  • A minimum of 7 years of finance, accounting, legal or other business function experience required; preferably pharmaceutical/device/healthcare.
  • Auditing or monitoring experience preferred.
  • Data analytics experience preferred.
    ______________________________________________________________________________________________
Knowledge


Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

  • Knowledge of various laws, regulations, and industry guidance that affect Endo's compliance program, including federal and state government price reporting laws, fraud and abuse and anti-kickback statutes, PDMA, OIG and AdvaMed and PhRMA guidelines, state and federal aggregate spend reporting laws and corporate integrity agreements.
    ______________________________________________________________________________________________
Skills & Abilities


Often referred to as "competencies", leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific
e.g. coaching, negotiation, calibration, technical writing etc.

  • Experience with use of analytical tools for data analysis.
  • Experience with monitoring and auditing promotional and non-promotional activities.
  • Demonstrated ability to build and manage effective relationships with strong inter-personal skills and business acumen.
  • Effective time management skills and ability to handle multiple projects simultaneously.
  • Strong managerial and leadership skills.
    ______________________________________________________________________________________________
Physical Requirements


Physical & mental requirements
e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

  • Ability to travel up to 30% of time.
    ______________________________________________________________________________________________

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 5/4/2018

DIRECTOR, GLOBAL COMPLIANCE POLICY, TRAINING, & PROCESS IMPROVEMENT - Smith & Nephew
Fort Worth, TX


ABOUT US
Smith & Nephew is a diversified advanced medical technology business that supports healthcare professionals in more than 100 countries to improve the quality of life for their patients.

We have leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma:

  • Orthopedics Reconstruction - joint replacement systems for knees, hips and shoulders
  • Advanced Wound Management - wound care treatment and prevention products used to treat hard-to-heal wounds
  • Sports Medicine - minimally invasive surgery of the joint
  • Trauma & Extremities - products that help repair broken bones

We have over 15,000 employees around the world. Annual sales in 2016 were more than $4.6 billion. We are a constituent of the UK's FTSE100.

SUMMARY
The Director, Global Compliance Policy, Training, and Process Improvement manages a dispersed team who help support the following activities designed to support the company's anti-bribery and anti-corruption program:

  • Develop and maintain compliance controls (policies).
  • Train targeted audiences on those controls and assess training effectiveness; use communications and other tools to share information about compliance and reinforce key messages.
  • Helps identify and manage actions to address to the root cause of failures; use process improvement skills to help develop and improve compliance processes and systems.
  • Ensure compliance systems support the program, as needed.
  • Collaborate with global stakeholders and sit on the Office of Ethics and Compliance Leadership Team.
This role regularly interacts with the Chief Compliance Officer, Compliance Officers, Senior Business Leaders, and General Managers to ensure the Global Compliance Program is implemented.

ESSENTIAL FUNCTIONS

  • Training: Manage team involved in the development and delivery of educational resources and training projects in support of a global anti-bribery/corruption and U.S. healthcare law compliance program, including setting strategy, performing needs assessments, designing/developing training, developing curricula, assigning training, following up on late training, and assessing effectiveness.
  • Policy / Communication: Lead teams in formulating the company Code of Conduct, policies, standards and guidelines to ensure they comply with relevant external legal, regulatory and Works Council requirements. Direct departmental communications, including policy changes, newsletters, compliance alerts, reporting line awareness, etc.; write compliance sections for the company's Annual Report and Sustainability Report.
  • Systems / Metrics, Process Improvement: Work with team members and IT to support compliance systems, such as SharePoint, TeamMate and a Healthcare Professional Engagement database. Oversee the development of metrics and reports to the Board and the Executives, to measure operational performance and performance against key indicators, and assist with process improvements.

REQUIREMENTS
  Travel: Up to 25% of the time.

  Education: Bachelor Degree and Master's degree preferred.

  Professional Experience:

  • 10 to 12 years or more experience related to implementing any of the following: legal, regulatory or compliance programs within a business.
  • Ideally, the qualified candidate will have professional experience that reflects progressive responsibility.
  Competencies:
  • Strong communication skills, written and verbal
  • Excellent process development skills ideally with operational excellence / process improvement experience.
  • Understanding of adult learning principles, instructional design, and training effectiveness assessment methods.
  • Detail-oriented.
  • Comfortable with systems and data.

Smith and Nephew is an Equal Opportunity / Affirmative Action Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by applicable law.

 Apply here
Posted 5/2/2018

SENIOR ANALYST, COMPLIANCE MONITOR - Regeneron
Tarrytown, NY, US
Requisition Number: 13092BR
Employment Type: Regular Employee


Position Summary:
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:
This newly created position will provide support for a broad range of compliance issues, with a focus on compliance monitoring and reviewing and approving external funding requests. The position requires an understanding of healthcare laws, including the Food, Drug and Cosmetic Act, fraud and abuse laws, as well as the compliance enforcement environment. The ideal candidate will have strong communications skills, be proactive, be able to work independently and collaboratively in a team environment, and manage multiple projects and clients. The position will directly interact with clients and departments across Regeneron and the candidate must have proven experience in working collaboratively.

Responsibilities:

  • Oversee the review and approval of external funding requests, including educational grants, exhibits and displays, sponsorships, and charitable donations. Will serve as voting member on relevant committees for review of these funding requests and will be instrumental in advising and updating relevant policies, procedures and job aids to ensure process efficiencies.
  • In connection with Compliance Monitoring, (1) conduct monitoring visits with field-based employees, and attend various company-sponsored activities to monitor compliance with laws, regulations, industry codes, and Company policies, (2) assist with implementation of compliance monitoring plan which includes reviewing records and systems relating to interactions with healthcare professionals and institutions and (3) develop and maintain protocols, guidelines and associated internal communication related to Compliance testing and monitoring, as needed.
  • Review and follow-up on suspected areas of non-compliance in collaboration with Company business leads and investigations team, as needed. Collaborate with members of the Compliance Department and business leads to help develop and implement remediation plans.
  • Assist with preparation of quarterly and ad hoc reports and, presentations summarizing auditing and monitoring activities.
  • Organize training for compliance monitors and learn (1) Company products and indications, (2) industry regulations and guidelines (e.g., laws and regulations regarding pharmaceutical advertising and promotion, Federal Anti-Kickback Statute, False Claims Act, PDMA), Company policies and procedures, and government reporting requirements, as needed.

Requirements:

  • Bachelor's degree from an accredited institution, with an advanced degree preferred.
  • 7 years of compliance professional and/or relevant paralegal experience, with at least 5 years working in a pharmaceutical or biotechnology company
  • Compliance auditing and/or monitoring experience in the pharmaceutical or life sciences industry is preferred.
  • Exceptional oral and written communication skills, presentation capabilities, interpersonal skills and strong problem solving/conflict resolution skills.
  • Ability to maintain an independent and objective perspective while developing and maintaining a strong partnership with client organizations.
  • Ability to communicate and negotiate effectively at all levels throughout the company.
  • History of self-motivation, working independently on projects, meeting aggressive deadlines, and ability to multi-task and manage competing priorities.
  • Uncompromising ethics and high standard of personal integrity
  • Demonstrated knowledge and understanding of the Anti-Kickback Statute and False Claims Act, FDA rules and regulations regarding the promotion of pharmaceuticals, corporate integrity agreements, PhRMA code, and other relevant reporting/legal requirements.
  • Proficiency in Microsoft Office Suite.
  • Significant travel is required.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

 Apply here
Posted 4/26/2018

ASSOCIATE MANAGER, COMPLIANCE DATA ANALYST - Regeneron
Tarrytown, NY, US
Requisition Number: 13090BR
Employment Type: Regular Employee


Position Summary:
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:
The Compliance Data Analyst will be a member of the Compliance Monitoring Team that reviews various activities for consistency with the Company's policies and procedures and applicable laws and regulations. The position requires an understanding of healthcare laws, including the Food, Drug and Cosmetic Act, fraud and abuse laws, as well as the compliance enforcement environment. The ideal candidate will have strong communications skills, be proactive, be able to work independently and collaboratively in a team environment, and manage multiple projects and clients. The position will directly interact with clients and departments across Regeneron.

Responsibilities:
The Data Analyst will assist with implementation of the compliance monitoring plan by reviewing complex data, records and systems relating to interactions with healthcare professionals and institutions. The ideal candidate will have a strong understanding of databases and data analyses procedures, be tech-savvy and possess excellent troubleshooting skills. The Data Analyst's responsibilities may also include interacting with development and end-users to obtain the necessary data from different systems to address compliance monitoring needs. The analyst will work under general supervision and assist in the analysis and development of data requirements for the Compliance Department. He/She must be able to work independently and efficiently organize, store and analyze data with attention to security and confidentiality. Other responsibilities include:

  • Develop and coordinate an organization-wide privacy risk management and compliance framework and governance structure by undertaking a comprehensive review of the Company's data and privacy process and procedures for each applicable business function to ensure that they are consistent with relevant laws and regulations and the Company's privacy and data security goals and policies
  • Develop, manage and assist in the implementation and maintenance of the Company's information privacy policies and procedures to ensure that business activities are consistent with them
  • Provide leadership in the design and evaluation of privacy and security related projects so that new business activities are developed with privacy by design principles in mind
  • Establish a mechanism to track access and retention of protected health information maintained by the Company
  • Periodically revise the privacy program to reflect changes in laws, regulatory or Company policy and accreditation standards, and monitor advancements in information privacy technologies to ensure organizational adaptation and compliance, as needed
  • Develop privacy training materials and other communications to train employees and third parties, as appropriate, on company privacy policies, data handling practices and procedures and legal obligations
  • Collaborate with internal audit to establish an internal and external privacy audit program

Requirements:

  • BS/BA required. Advanced degree in quantitative subject (e.g. Statistics, Econometrics, Mathematics) preferred
  • A minimum of 5 years analytical experience in pharmaceutical or biotechnology industries related to the commercial products and/or compliance setting
  • Commercial business intelligence tool report creation experience required (any, but e.g.: QlikView, Tableau, Oracle BI, Microstrategy, Cognos, Spotfire)
  • SAS code-writing skills (BASE, STAT, Tableau, SQL, Macros) preferred, SQL query-writing preferred.
  • Experience working with data in MS Office (Excel/Access) and/or BI tools
  • In-depth knowledge and data mining experience
  • Commercial business intelligence tool report creation experience required (any, but e.g.: QlikView, Tableau, Oracle BI, Microstrategy, Cognos, Spotfire)
  • Experience in primary market research preferred
  • Advanced proficiency in Word, Excel, and PowerPoint required
  • Experience managing large scale projects with Six Sigma Lean/PMP certification preferred
  • Presentation skills to take sophisticated analysis and apply a business context for non-analytical audience required
  • Develop and maintain documentation and training materials regarding the reports and the data contained, serve as a training resource to new and existing users in both formal and informal settings
  • Perform ad hoc analyses to understand impacts of data issues, troubleshoot inquiries, enhance quality controls, answer questions and present findings to stakeholders
  • Develop and maintain quality assurance procedures for the field reports and any deliverables
  • As business needs evolve, capture requirements across all key stakeholders and manage changes to reports, metrics, business rules and processes
  • History of self-motivation, working independently on projects, meeting aggressive deadlines, and ability to multi-task and manage competing priorities
  • Uncompromising ethics and high standard of personal integrity
  • Demonstrated knowledge and understanding of the Anti-Kickback Statute and False Claims Act, FDA rules and regulations regarding the promotion of pharmaceuticals, corporate integrity agreements, PhRMA code, and other relevant reporting/legal requirements

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

 Apply here
Posted 4/26/2018

ASSOCIATE DIRECTOR, CORPORATE COUNSEL - REGULATORY AND COMMERCIAL - Regeneron
Tarrytown, NY, US
Requisition Number: 13089BR
Employment Type: Regular Employee


Position Summary:
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:
We are seeking a Corporate Counsel to join the Regulatory and Commercial Law Group. The position will provide will provide proactive and collaborative legal support in connection with one or more of Regeneron's products and legal advice to a wide range of internal clients, including sales, commercial, medical affairs, regulatory, and compliance. The level of counseling requires a deep understanding of healthcare laws, including the Food, Drug and Cosmetic Act, and laws related to discovery, development and sales and marketing of biotechnology products (including healthcare fraud and abuse laws). The ideal candidate will have relevant in-house experience counseling on an approved product and providing practical and strategic legal advice on a broad range of issues.

Responsibilities:

  • Provides product support counseling for one or more Regeneron products/product candidates from development through commercialization and lifecycle planning.
    • Counsels on launch preparation activities for product candidates
    • Advises on brand-related strategic planning and business operating plans
    • Reviews and approves promotional materials and strategies
    • Advises on FDA regulatory submissions and label negotiations
    • Reviews and approves medical materials and publications
    • Provides day-to-day counseling on advertising and promotion, drug safety, scientific exchange, strategic commercial activities, interactions with healthcare professionals, and external funding activities.
    • Trains and educates clients on enforcement trends and discrete legal issues.
    • Has proven ability to influence clients by identifying and communicating relevant legal risks and understanding the impact that decisions may have on business activities.
  • Provides counsel and support to Compliance, including supporting policy development and providing training to commercial, medical, sales and other departments
  • Assists with a broad range of other healthcare regulatory matters including monitoring the enforcement environment, client training, compliance monitoring and investigations, market access, patient advocacy, contracts, patient assistance programs, and policy development.

Requirements:
      Qualifications

  • JD with 5+ years relevant legal experience
  • Licensed to practice law in New York or be eligible for licensure as a registered in-house counsel.
  • Prior in-house healthcare/pharmaceutical and/or biotech experience strongly preferred.
  • Significant knowledge of life sciences regulatory enforcement trends, the FDCA, the false claims act, and fraud and abuse laws
  • Excellent interpersonal and conflict resolution skills and ability to work in highly collaborative, team-oriented environment.

  • Essential Skills and Abilities
  • Exceptional oral and written communication skills, including drafting skills, and presentation capabilities.
  • Ability to maintain an independent and objective perspective while developing and maintaining a strong partnership with the client organizations.
  • History of self-motivation, working independently on projects, meeting aggressive deadlines, and juggling multiple matters.
  • Market access counseling experience a plus.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

 Apply here
Posted 4/26/2018

SENIOR MANAGER, COMPLIANCE - Regeneron
Tarrytown, NY, US
Requisition Number: 13093BR
Employment Type: Regular Employee


Position Summary:
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:
We are currently seeking a Senior Manager, Compliance Reporting to join our Global Transparency Reporting team in our Tarrytown, New York facility. This position will report to the Director, Compliance Reporting in the Regeneron Law Department and will be responsible for data collection and aggregation related to all aspects of Regeneron's US Transparency Program.

Responsibilities:
In this position, you will be responsible for:

  • Working directly with internal and external parties to ensure procedures are in place to obtain data for reporting. This includes establishing new procedures where required.
  • Tracking reports received from third parties and performing high-level reviews and analysis of reports to determine completeness of data. Evaluate when additional data is needed and obtains additional information from third-parties when appropriate.
  • Upload completed reports into the Company's Aggregate Spend system and perform detailed reconciliations to determine proper aggregation within the system.
  • Performing analysis surrounding Healthcare Professionals (HCPs), including verification of licenses when necessary. Reviewing HCPs not passing validation with CMS and make the determination as to potential residency status.
  • Preparing submission reports from the Company's Aggregate spend system and determining completeness of such reports.
  • Attend industry related trainings and bring back knowledge obtained to share with the team.

You will work closely with compliance team members and others across the organization to collect reports on and track expenditures to HCPs and institutions to satisfy applicable US State and Federal aggregate spend and related transparency regulations.

Requirements:
Qualified candidates will have at least a Bachelor's degree in Business or related field and a minimum 7 year experience working in an accounting, finance or compliance function in the pharmaceutical/life sciences industry. A broad knowledge working with Excel, PowerPoint, SharePoint, and, multiple operating systems and browsers is required. Prior knowledge of Aggregate Spend reporting is highly desired.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

 Apply here
Posted 4/26/2018

ASSOCIATE DIRECTOR, GLOBAL DATA PRIVACY COUNSEL - Regeneron
Tarrytown, NY, US
Requisition Number: 8397BR
Employment Type: Regular Employee


Position Summary:
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

The Associate Director, Data Privacy will support our growing organization ensuring full compliance with all applicable privacy laws and regulations globally. In particular the individual will be responsible for developing and enhancing the Company's global privacy program. The position will interact with departments across Regeneron.

Responsibilities:

  • Build & Improve the Company's Privacy Program
  • Develop and coordinate an organization-wide privacy risk management and compliance framework and governance structure by undertaking a comprehensive review of the Company's data and privacy process and procedures for each applicable business function to ensure that they are consistent with relevant laws and regulations and the Company's privacy and data security goals and policies
  • Develop, manage and assist in the implementation and maintenance of the Company's information privacy policies and procedures to ensure that business activities are consistent with them
  • Provide leadership in the design and evaluation of privacy and security related projects so that new business activities are developed with privacy by design principles in mind
  • Establish a mechanism to track access and retention of protected health information maintained by the Company
  • Periodically revise the privacy program to reflect changes in laws, regulatory or Company policy and accreditation standards, and monitor advancements in information privacy technologies to ensure organizational adaptation and compliance, as needed
  • Develop privacy training materials and other communications to train employees and third parties, as appropriate, on company privacy policies, data handling practices and procedures and legal obligations
  • Collaborate with internal audit to establish an internal and external privacy audit program

Intra-organizational Collaboration:

  • Work with business teams and senior management to ensure awareness of "best practices" on privacy and data security issues
  • Collaborate on cyber privacy and security policies and procedures
  • Interface with Senior Management to develop strategic plans for the collection, use and sharing of information in a manner that maximizes its value while complying with applicable privacy regulations
  • Assist business units with development of tools and methodologies to ensure ongoing compliance
  • Provide strategic guidance to corporate officers regarding information resources and technology
  • Assist the Chief Information Officer with the development and implementation of an information infrastructure
  • Serve as the information privacy liaison for users of technology systems
  • Act as a liaison to the information technology department
  • Collaborate with the legal department on privacy issues relating to business partner contracts and product-related activities
  • Collaborate with the Compliance Investigations Team to develop a process for receiving, documenting, tracking, investigating and taking action on all privacy related complaints

Data Governance:

  • Assure that the use of technologies maintain, and do not erode, privacy protections on use, collection and disclosure of personal information
  • Monitor systems development and operations for security and privacy compliance
  • Conduct privacy impact assessments of proposed rules on the privacy of personal information, including the type of personal information collected and the number of people affected
  • Conduct periodic information privacy impact assessments and ongoing compliance monitoring activities in coordination with the organization's other compliance and operational assessment functions including the Compliance Monitoring Team
  • Review all system-related information security plans to ensure alignment between security and privacy practices

#LI-LC1:

  • At least 5 years of experience in the privacy profession, with at least five years working in or with pharmaceutical companies on healthcare privacy related activities
  • In-depth knowledge of US and EU privacy laws related to the pharmaceutical and clinical research industry
  • Experience with building and implementing a global privacy program
  • Pharmaceutical and/or biotech experience required
  • High level of influencing skills and the ability to drive change as it relates to implementing remedial actions

The ideal candidate will thrive in a highly collaborative, team oriented environment. He/She must have excellent interpersonal and conflict resolution skills.

 Apply here
Posted 4/26/2018

ASSOCIATE DIRECTOR, COMPLIANCE MONITORING - Regeneron
Tarrytown, NY, US
Requisition Number: 13091BR
Employment Type: Regular Employee


Position Summary:
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:
This position will provide support for a broad range of compliance issues, with a focus on compliance monitoring. The position requires an understanding of healthcare laws, including the Food, Drug and Cosmetic Act, fraud and abuse laws, as well as the compliance enforcement environment. The ideal candidate will have strong communications skills, be proactive, be able to work independently and collaboratively in a team environment, and manage multiple projects and clients. The position will directly interact with clients and departments across Regeneron and the candidate must have proven experience in working collaboratively.

Responsibilities:

  • Assist with the execution of the Company's compliance monitoring plan, including reviewing records, data and systems relating to interactions with healthcare professionals and institutions
  • Develop and maintain protocols, guidelines and associated internal communication related to Compliance testing and monitoring
  • Assist with drafting compliance monitoring activity reports describing the results of the monitoring activities, identifying trends and/or gaps
  • Filtering and "cleaning" data, and reviewing computer reports, printouts, and performance indicators to locate and correct code problems
  • Documenting structure of company business data, which serves as a guide in execution of tasks
  • Interpreting business data being monitored and analyzing results using statistical techniques and creating comprehensive data reports
  • Review and follow-up on suspected areas of non-compliance in collaboration with Company business leads and investigations team, as needed. Collaborate with members of the Compliance Department and business leads to help develop and implement remediation plans
  • Assist with preparation of presentations summarizing auditing and monitoring activities
  • Learn (1) Company products and indications, (2) Company policies and procedures, and (3) government reporting requirements, and applicable industry regulations/laws to identify and monitor potential compliance risks

Requirements:

  • Bachelor's degree from an accredited institution, with an advanced degree preferred
  • 7 years of compliance professional and/or relevant compliance monitoring experience, with at least 5 years working in a pharmaceutical or biotechnology company
  • Exceptional oral and written communication skills, presentation capabilities, interpersonal skills and strong problem solving/conflict resolution skills
  • Ability to maintain an independent and objective perspective while developing and maintaining a strong partnership with client organizations
  • Ability to communicate and negotiate effectively at all levels throughout the Company
  • History of self-motivation, working independently on projects, meeting aggressive deadlines, and ability to multi-task and manage competing priorities
  • Uncompromising ethics and high standard of personal integrity
  • Demonstrated knowledge and understanding of the Anti-Kickback Statute and False Claims Act, FDA rules and regulations regarding the promotion of pharmaceuticals, corporate integrity agreements, PhRMA code, and other relevant reporting/legal requirements
  • Proficiency in Microsoft Office Suite, Visio and Access
  • Advanced proficiency in Word, Excel, and PowerPoint required
  • 15% travel is required

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

 Apply here
Posted 4/26/2018