For information about placing your employment listing on this page, contact Joe Braden at info@PharmaComplianceForum.org.
Cost is complimentary for PCF Members and $600 for 90 days for non members.
EMPLOYMENT OPPORTUNITIES
COMPLIANCE MANAGER - Meda
Description of Role
Meda is a dynamic pharmaceutical development and sales company with a growing portfolio of prescription and over-the-counter products. We are the U.S. arm of Meda AB, a Sweden based company that is one of the world's top 50 pharmaceutical groups.
We are seeking a self-directed individual to manage programs which ensure that our promotional messages are accurate and consistently delivered, that our interactions with healthcare professionals are properly focused on our products' appropriate role in treatment, and that we are meeting state and federal reporting requirements. This role involves running and refining the existing programs, and assisting the Compliance Officer in creating new programs in the areas of clinical development, government program compliance, and a range of other legal and ethical requirements for U.S. pharmaceutical operations.
This position may be based in Somerset, New Jersey and will require approximately 20% travel, including trips to the other sites and across the country, to conduct audits and attend meetings with field sales representatives and managers, and to conferences.
Specific Responsibilities
- Write and edit policies and procedures, including standard operating procedures and other guidance. Creative, organized, clear and grammatically correct written communication is essential. We are building the best guidance system, not just cutting and pasting.
- Develop and deliver effective training. Training media will include written materials, computer delivered instruction and live presentations. This position will involve speaking effectively to groups of up to 20 people, and assisting the Compliance Officer in developing presentations for hundreds. The candidate will be expected to have sound opinions about what makes training effective, tests valid and documentation comprehensive.
- Administer monitoring and auditing of policies and procedures.
- Structure and implement documentation systems to assure comprehensiveness, maximize efficiency and provide a solid basis to demonstrate that Meda's business conduct is ethical and legal.
- Work effectively with a wide range of people and departments to promote a camaraderie that upholds ethical and legal standards, while raising morale and supporting the company's overall objectives.
Qualifications
- Knowledge of how pharmaceutical marketing and sales operations function, and how compliance programs are effectively administered with them.
- Knowledge of applicable laws and regulations, and knowledge of industry guidelines and best practices in compliance programs, including anti-kickback statutes and other marketing restrictions, and some cGXP awareness.
- Specific accomplishments in writing guidance documents, in developing training programs and in administering monitoring and audit programs.
- Demonstrated competence in developing and delivering paper-based, computer-based and in-person training.
- At least three years of experience directly with the items listed in Specific Responsibilities above, or at least five years of other relevant experience.
Apply directly to the position online through the following link: https://home.eease.adp.com/recruit/?id=1213391
Posted 2/7/2012
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ASSOCIATE DIRECTOR, COMMERCIAL COMPLIANCE - Boehringer Ingelheim
Boehringer Ingelheim is currently seeking a talented and innovative Associate Director, Commercial Compliance to join our Compliance department located at our Ridgefield, CT facility.
As the Associate Director, Commercial Compliance you will assist in the development, implementation, and continuous improvement of an effective compliance program for all Commercial business activities. To support the risk assessment and analysis process to continuously evaluate risk areas and priorities to guide new Compliance efforts. To act as a business partner to the Prescription Medicine Department to provide assistance and advice on daily operations and ensure appropriate compliance controls, training, monitoring and auditing for identified business activities. To work closely with other teams within the Ethics and Compliance Department to ensure consistent application and implementation of identified compliance controls, training, monitoring, and auditing, as well as investigations of non-compliant activity and corrective action.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities:
- Participates in strategic planning for applicable departmental activities with the goal of providing compliance expertise and advice to ensure planning is efficient and considers compliance issues upfront. Also provides day-to-day support, advice and problem-solving expertise to applicable businesses to ensure business operations are conducted in a fully compliant manner. Develops resources for applicable business areas, as needed, to help meet their respective compliance business needs.
- Provides compliance expertise to applicable department leaders to develop policies, processes and procedures that support the business activities to ensure execution in a fully compliant manner.
- Assesses training needs for business groups, provides input into training plans, and collaborates with appropriate individuals to develop training content, acting as subject matter expert for business area. Facilitates and delivers training as appropriate.
- Develops and executes monitoring of key business activities for proactive compliance management. Directs regular reports as needed on monitoring activities to appropriate Compliance and business leadership. Analyzes monitoring results to identify trends and recommend improvements in Compliance or business operations.
- Provides input into annual auditing plan for business activities, driven by a risk-based analysis and prioritization and in collaboration with applicable department leaders. Collaborates with personnel responsible for auditing plans to execute the auditing plan, including developing and executing action plans for identified CAPAs (Corrective and Preventative Actions) and monitoring established controls after implementation. Analyzes auditing results to recommend improvements in Compliance or business operations.
- Supports other activities of Commercial Compliance Department, including risk assessment and strategic planning, training and communication, health care provider interaction initiatives (i.e., implementation of fair market value, Sunshine Act requirements), and development of ethical business culture.
- Acts as liaison with BI GmbH business and compliance colleagues to influence the conduct of global activities that implicate US laws and regulations.
- Monitors external environment and recommends improvements to the company's compliance program based on identified industry best practices.
- Performs all Company business in accordance with all regulations (e.g. EEO, FDA, OSHA, PDMA, EPA, PhRMA, etc.) and Company policies and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrates high ethical and professional standards with all business contacts in order to maintain BIPI's excellent reputation within the medical and pharmaceutical community.
Required Education & Experience:
- Bachelor's degree (BA, BS) required; degree in business or scientific function preferred
- Minimum 5 years experience in the pharmaceutical/biotech industry, to include experience with the commercial business, process management, and/or related function; previous regulatory or pharmaceutical compliance experience preferred
Desired Experience, Skills and Abilities:
- Experience in Oncology or Managed Markets is highly desirable.
- Demonstrated ability to read, analyze, and interpret business and regulatory information and legal advice. Problem-solving expertise required.
- Ability to operate independently with minimal supervision.
- Demonstrated in depth knowledge of Sales, Marketing or Managed Markets systems, processes and policies relative to compliance requirements.
- Demonstrated project management skills in complex situations with internal (all BIPI) and external customers.
- Demonstrated ability to communicate effectively with individuals up, down, and across the organization
- Demonstrated leadership skills, including ability to lead change efforts through effective communication and persuasion.
- History of successful performance
- Demonstrated acceptable level of performance for all applicable competencies as defined in the On Track To Success Competency Model.
- Proficiency in MSOffice, Outlook and database applications.
- Ability to travel (may include overnight travel).
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment background investigations and drug screenings. Boehringer Ingelheim is an equal opportunity employer. M/F/D/V
Qualified applicants can email Ryan Mehan- ryan.mehan@rightthinginc.com
Posted 1/9/2012
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SENIOR PHARMACEUTICAL COMPLIANCE SPECIALIST - Allergan
Allergan is a global, technology-driven multi-specialty health care company pursuing therapeutic advances to help patients live life to their fullest potential. In making this commitment, we work to develop an unparalleled level of insight into patients' wants and needs - and into the priorities and concerns of the medical specialists who treat them. To this end, we employ more than 50 percent of our work force in either research and development (R&D) or sales, ensuring our efforts are focused on innovation and our customers.
This position is responsible for assisting the Director/Sr. Director, Compliance in providing guidance and support regarding Commercial and Medical Affairs activities associated with Allergan's US Healthcare Law Compliance Program. Job responsibilities include developing a process for collecting and maintaining documentation for certain business activities, including sponsorships, advisory boards, charitable contributions and medical education grants as well as participating in the review and approval of such activities. In addition, this position will assist the Director/Sr. Director, Compliance in reviewing and updating as appropriate any applicable policies and procedures, developing and conducting necessary training, and filing all applicable state marketing law reports, as necessary.
Job Summary:
- Develops and maintains a process for collecting and keeping documentation regarding certain business activities, including sponsorships, advisory boards, other HCP/HCI consulting arrangements, charitable contributions and medical education grants.
- Participates in the review and approval of such activities, among other compliance-related approvals, as necessary.
- Assists Compliance Director/Sr Director with necessary advisement and guidance regarding Allergan's Healthcare Law Compliance Program.
- Provides timely, competent and efficient advice and support for questions and concerns regarding the compliance program, including addressing employee complaints and concerns.
- Liaise with sales, business operations, marketing, and medical affairs departments in all compliance-related activities.
- Provide training assistance to teams, as needed. As necessary, monitors state law initiatives for pending changes.
- Prepare internal state monitoring reports for compliance to Allergan's Healthcare Law Compliance Polices.
- Prepare compliance reports for review by senior management and oversight committees.
- Assists in ad hoc projects related to general corporate compliance concerns and issues, including developing compliance requirements policies, documents, deliverables and training
Education and Experience
- BA/BS
- 4 to 5 years legal healthcare/pharmaceutical and device legal experience.
- Awareness of federal fraud and abuse laws and guidances, including the ACCME guidelines, the Office of Inspector General reports, and the Food, Drug and Cosmetic Act and an understanding of the roles and authority of government agencies and industry cooperative groups including FDA, OIG, PhRMA and AdvaMed.
Essential Skills and Abilities
- Exceptional communication skills, including presentation capabilities, interpersonal skills and conflict resolution.
Please click on the link below to apply for this position:
http://allergan.taleo.net/careersection/usa_external/jobdetail.ftl?lang=en&job=111251&src=PA-111251
Posted 12/16/2011
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ASSOCIATE DIRECTOR, COPORATE COMPLIANCE - MedImmune
"My company shares my
passion for helping to improve
human health around the world."
"This is My MedImmune."
Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc.
Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities…that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world.
Title: Associate Director, Corporate Compliance
Location: Gaithersburg, MD
Req: 6179
As member of the Corporate Compliance Department, the Associate Director will be responsible to partner with stakeholders in MedImmune's Commercial Organization in order enhance the Company's healthcare compliance initiatives aimed to mitigate risks in the areas of Anti-bribery and Anti-corruption, pre-approval and off-label promotion, and privacy.
Position:
Specific responsibilities include:
- Partner with stakeholders within the Commercial Organization to build and sustain accountability for compliance risks
- Develop policies, procedures and business self-monitoring programs to address compliance risks as appropriate
- Partner with embedded training departments to maintain a high level of awareness and conduct training on compliance risks, as well as the policies and procedures developed to mitigate these risks
- Partner with Independent Compliance Monitoring and Investigation leads
- Incorporate learnings from reports of non-compliance into ongoing enhancement of compliance program
- Provide project management support to specific compliance initiatives (including developing cross functional support, developing budgets, project timelines, etc.)
- Partner with AstraZeneca Compliance counterparts to ensure alignment and leverage resources where possible
- Assist Director with reports/briefings to the MedI GC, Board and AZ Global Compliance Committee
- In addition to solid skills, must be a creative thinker with good judgment and a strong desire to help grow the company's capabilities and work in a fast-paced and fluid environment
- Other duties as assigned by the Director from time to time
The position will coordinate Commercial Compliance activities across the US and will also work closely with MedImmune's R&D and other compliance functions to ensure overall continuity of the Corporate wide compliance program.
- 5-10 years experience in the Pharmaceutical or Biotech Industry
- Familiarity with regulatory and fraud & abuse risks relative to US Sales & Marketing of pharmaceuticals strongly preferred
- 3-5 years in a healthcare compliance role
Education:
Bachelor's Degree, Advanced Degree Preferred
- Demonstrated knowledge and understanding of effective compliance programs and experience in developing and implementing program elements
- Ability to partner with and forge strong working relationships with employees in different disciplines and at all levels of the organization.
- Ability to to build rapport and facilitate buy in through collaboration with others, across multiple parts of the organization
- Demonstrated analytical skills and an innovative and creative approach to complex problem solving, with effective strategy development and delivery skills
- Training/ teaching skills
- Strong organization and time management skills
- Knowledge of legal/regulatory processes
- Leadership, interpersonal, communications, assertiveness and negotiation skills
- Proactive, continuously seeking further advancement of the program and being willing to challenge the status quo
- Ability to manage a diverse group of responsibilities
- Ability to manage change within the business
- Ability to work effectively where situations or details may be ambiguous
- Clarity on direction, understands and manages risks
- Builds relationships, striving to improve cross-functional working and eliminating non-value adding activities
- Works effectively in am eAbility to travel when required
Comfortable working independently and willing to work in a proactive manner
- Position requires ability to manage several projects, long and short term simultaneously
- Ability to be flexible and revise priorities as required by the business needs
- Ability to coordinate and collaborate with people across the company and with colleagues at Parent Company
To apply online please click here:
http://www.candidatecare.com/srccsh/RTI.home?r=2000010777210&d=medimmune.candidatecare.com
MedImmune is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.
MedImmune does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on MedImmune's approved agency list. Unsolicited resumes or candidate information submitted to MedImmune by search/recruiting agencies not already on MedImmune's approved agency list shall become the property of MedImmune and if the candidate is subsequently hired by MedImmune, MedImmune shall not owe any fee to the submitting agency.
Posted 12/16/2011
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COMPLIANCE AND REPORTING ANALYST - Noven Pharmaceuticals, Miami, FL
Overall Responsibilities:
Lead responsibility for Noven transparency program and analytical support for other compliance projects and programs.
Job Description
Support Noven to prepare physician payment transparency reports required by the Federal Physician Payment Sunshine Provisions of the Patient Protection and Affordable Care Act and prepare filing reports for states with reporting requirements. Support the Compliance Department with Compliance initiatives pertaining to aggregate spend, transparency, and interactions with Healthcare Professionals/Organizations, record retention and privacy. This position also supports the Compliance department with analytical and monitoring and auditing functions for all departmental responsibilities. The position interacts regularly with Information Technology and other business areas and departments including but not limited to:
Finance, Marketing, Sales, Regulatory Affairs, Clinical Affairs, Business Development.
The position will also interact with external customers including Healthcare professionals, and third party/external vendors.
Transparency Reporting Responsibilities
- Assist on business and technical projects associated with Noven aggregate spend program
- Assist with the gathering of information/data and preparations of physician payment transparency reports as specified in the Physician Payment Sunshine provisions.
- Assist with the gathering of information/data and preparations of physician payment transparency reports for states with existing and future reporting requirements.
- Interface with Noven colleagues in other departments as appropriate to gather data and required information for reporting and tracking healthcare professional payments and transparency requirements.
- Manage data feeds coming in from Noven systems and external vendors which include mitigating errors and exceptions, uploading customer master to source feeds on a predetermined time frame.
- Manage the Aggregating system to generate all relevant Federal/State reports, and responses to ad-hoc analysis needs
- Coordinate with IT and vendor to develop new system enhancements and/or state law, federal law, or internal reports.
- Review state and federal reports at least quarterly for validation of data uploads
- Monitor data within aggregating system for spending alerts, fee caps, and other data analysis as required with appropriate follow up
- Respond to inquiries and resolve issues related to data submitted by vendors which required analysis or resubmissions.
- Respond to inquiries from HCPs, external parties, field sales employees, and internal Noven personnel to answer questions associated with HCP reported information from transparency and state reports.
- Review expense reports flagged for review from the Concur expense reporting system and follow up with the appropriate personnel to resolve discrepancies.
- Analyze and recommend ad hoc compliance reports related to aggregate spend data.
- Work with compliance personnel responsible for monitoring, auditing, and investigations to ensure that any allegation or identified violation of company policy related to aggregate spend is properly investigated, remediation taken, and monitor controls established to prevent future instances.
Compliance Monitoring & Auditing Responsibilities
- Conduct audits on expense reports submitted by field sales personnel to ensure compliance with Noven's Ethics and Compliance policies
- Review Speaker Program process and documentation to ensure compliance with Noven's Ethics and Compliance policies
- Conduct field ride alongs to audit sales representatives' interactions with HCPs
- Review and monitor Field Coaching Reports (FCRs), Adverse Events, and Medical Inquiries
- Assist with auditing of Privacy and Records compliance
- Support the Compliance department with other projects and programs including cross-training on Sample Accountability
Job Requirements
Key Skills and Competencies
- Experience developing business requirements and working with IT to translate these requirements into technical solutions
- Demonstrate solid knowledge of technology solutions and systems
- Ability to manage multiple projects that require collaboration across several functional areas.
- Good communication and organizational skills required
- Strong detail orientation and focus on quality work product due to the complex and sensitive need for data integrity
- Demonstrate flexibility and willingness to approach and take on new tasks
- Pharmaceutical experience a plus
- Knowledge and experience with pharmaceutical aggregate spend solutions, master data management, and data associated with promotional and clinical data a plus
- Understanding of Physician Sunshine Payment Provisions of Patient Protection and Affordable Care Act and pharmaceutical industry transparency requirements a plus
Education and Experience
BA/BS degree required.
Computer proficiency in MS Office Suite software required.
To apply, please follow this link: https://noven.hua.hrsmart.com/ats/js_job_details.php?reqid=364
Or, Contact: rkelly@noven.com
Posted 12/13/2011
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DIRECTOR, COMPLIANCE OPERATIONS - Endo Pharmaceuticals
Endo Pharmaceuticals is a U.S.-based, specialty healthcare solutions company, focused on high-value branded products and specialty generics. Endo is redefining its position in the healthcare marketplace by anticipating and embracing the evolution of health decisions based on the need for high-quality and cost-effective care. We aim to be the premier partner to healthcare professionals and payment providers, delivering an innovative suite of complementary diagnostics, drugs, devices and clinical data to meet the needs of patients in areas such as pain, urology, oncology and endocrinology. For more information about Endo Pharmaceuticals, and its wholly owned subsidiaries American Medical Systems, HealthTronics Inc., and Qualitest Pharmaceuticals, please visit www.endo.com.
To support our business strategies, we are currently seeking a Director, Compliance Operations to join our Corporate Compliance and Business Practices team at our Chadds Ford, PA Corporate Headquarters.
The Director will have direct responsibility for developing, implementing and overseeing compliance operations to ensure an effective enterprise wide compliance program. Serves as an integral member of the Corporate Compliance Leadership Team and will be expected to influence the strategic direction of Endo's Corporate Compliance Program.
Key Responsibilities:
- Developing and implementing in collaboration with other Department members annual and long term strategic compliance plans that reflect the elements of an effective compliance program across Endo's business segments and research and development functions.
- Overseeing compliance projects and programs related to aggregate spend, including but not limited to, tracking and reporting of required spend, prescription drug samples, clinical investigations and HCP spend.
- Overseeing and leading the development of enterprise wide metrics and key performance indicators that reflect the effectiveness of the corporate and business segment compliance programs.
- Developing reports and reporting capabilities for executive management and the Board on findings and established action plans to address critical findings.
- Overseeing comprehensive auditing and monitoring program for compliance risk areas and activities across enterprise and business segments.
- Coordinating corrective actions across the enterprise, business segments and business compliance programs.
- Coordinate with other Department members on the establishment of corporate privacy program to ensure adherence to privacy laws and to enhance trust with employees, physicians, patients and consumers.
- Coordinate with other Department members in the development of incident response plans in the event of an unauthorized disclosure of personal data.
- Enhancing Endo's investigative and disciplinary process across business segments.
- Leading and overseeing enterprise training initiatives and programs.
- Coordinating with Human Resources (Learning & Development), Corporate Communications, Information Management and business unit compliance teams to develop and deploy training and communications strategies and oversee execution of training and communications strategies.
- Collaborating with other corporate functions, including Legal, Finance, Human Resources and Information Management, to develop and maintain systems to support compliance operations and reporting.
- Managing governance of enterprise-wide compliance policies and tools.
To qualify for this role you will possess
- Bachelor's degree
- Law degree or similar advanced degree preferred.
- At least 8 years of compliance program experience as either a member of a corporate compliance team, consultant, or outside counsel. Proven record of accomplishment in the areas of compliance policies, training, auditing, monitoring and investigations
- Working knowledge of various laws, regulations, and industry guidance that affect the corporate-wide compliance program, including federal and state government price reporting laws, fraud and abuse and anti-kickback statutes, HIPAA and other privacy laws, OIG and PhRMA and AdvaMed guidelines, state marketing compliance laws, and anti-bribery laws.
- Effective public speaking skills and an ability to communicate in both verbal and written form with employees throughout the company.
- Must possess excellent organizational and planning skills and the capacity to simultaneously handle a variety of complex confidential issues.
To apply please follow this link:
http://tbe.taleo.net/NA6/ats/careers/requisition.jsp?org=ENDO&cws=1&rid=3635
Please note, we can only accept resumes via the career portal of our website.
Endo Pharmaceuticals Inc. recognizes the advantages of a diverse workforce achieved through a commitment to equal employment opportunities
Posted 12/7/2011
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COMPLIANCE ANALYST - PROMOTIONS - Forest Laboratories
Click here for complete information and to apply:
http://frx.com/careers/job_description.aspx?number=108064
Posted 11/28/2011
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ASSOCIATE DIRECTOR - COMPLIANCE - UCB
November 16, 2011
At UCB we are looking for enthusiastic and talented professionals who thrive on challenge and change. We are small enough for each member of our team to feel that their contribution counts and large enough to ensure that our combined efforts have an impact where it really matters while maintaining a work life balance for yourself.
UCB is currently looking for a dedicated Associate Director for U.S. Compliance with focus on standard cross functional project management and a variety of business operations areas revolving around our recently entered into Corporate Integrity Agreement (CIA). Position has responsibility for all CIA related project methodology, execution, and compliance operations support and collaboration both with other UCB stakeholders and third parties, including Health Care Professionals, (HCP), and Healthcare Institutions (HCI), vendors, etc. You will have the opportunity to work with and have visibility to all areas of UCB as well as presenting and interacting with all levels of the organization, including senior executives.
The Associate Director - Compliance you will:
- Covered Persons' Policy & Processes
- Engagement of HCPs Process & Systems
- Promotional Materials Review Processes
- Aggregate Spend & Transparency
- CIA Training
- Auditing & Monitoring of Certain Sales & Promotional Activities
- Manage & Resolve Complex Issues
UCB is building the next generation biopharma leader and you can be a part of this exciting challenge!
Required Education, Skills & Experience:
- Bachelors Degree
- Demonstrated experience managing multiple cross-functional teams and projects with a track record of successfully meeting deadlines, deliverables and budget parameters
- Ability to actively listen and process information to identify opportunities
- Ability to drive decision-making within a cross cultural, team structure
- Business acumen with a solid understanding of compliance and ethics within a highly regulated industry
- Proven leadership skills and strategic problem-solving ability.
- Proven ability to communicate and collaborate effectively with senior management
Preferred Education, Skills & Experience:
- Experience in the Pharma or Biotech industry
- Familiarity and project exposure to end-to-end initiatives with Corporate Integrity Agreement components
To apply, please follow this link:
https://ucb.taleo.net/careersection/10000/jobdetail.ftl Associate Director, Compliance-ATL00001423 or email your resume to careers@ucb.com
UCB recognizes the advantages of a diverse workforce achieved through a commitment to equal employment.
Posted 11/22/2011
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CORPORATE COMPLIANCE & BUSINESS PRACTICES MANAGER - AGGREGATE SPEND AND COMPLIANCE OPERATIONS - Endo Pharmaceuticals
Position ID: P0001707
Endo Pharmaceuticals is a U.S.-based, specialty healthcare solutions company, focused on high-value branded products and specialty generics. Endo is redefining its position in the healthcare marketplace by anticipating and embracing the evolution of health decisions based on the need for high-quality and cost-effective care. We aim to be the premier partner to healthcare professionals and payment providers, delivering an innovative suite of complementary diagnostics, drugs, devices and clinical data to meet the needs of patients in areas such as pain, urology, oncology and endocrinology. For more information about Endo Pharmaceuticals, and its wholly owned subsidiaries American Medical Systems, HealthTronics Inc., and Qualitest, please visit www.endo.com.
To support our critical business strategies, we are currently seeking a Manager Corporate Compliance and Business Practices - Aggregate Spend and Compliance Operations to join our Corporate Compliance and Business Practices team at our Chadds Ford, PA Headquarters.
Reporting to the Director, Compliance Operations and Privacy, Manager Corporate Compliance and Business Practices - Aggregate Spend and Compliance Operations will support Endo's aggregate spend strategy, oversee the implementation and effective operation of Endo's aggregate spend initiatives and programs and coordinate efforts to comply with the Federal Physician Payment Sunshine Act and existing and future state laws related to transparency and disclosure. The position will also be responsible for initiatives to further enhancement Endo's corporate compliance program in areas such as training, monitoring, auditing, reporting and investigations.
Your key responsibilites will be:
Support the Director, Compliance Operations and Privacy in achieving departmental goals, objectives, and responsibilities:
- Lead, manage and coordinate compliance projects and programs related to aggregate spend, including but not limited to, tracking and reporting of required spend and coordinate the reporting on prescription drug samples, pricing and clinical research. Develop, manage and enhance collaborative relationships across Compliance and Business Practices, Information Management and various Endo business partners. Develop and manage the process for ensuring that business requirements of spend reporting systems are up-to-date based on current state and federal reporting requirements.
- Develop, manage and enhance monitoring of aggregate spend tracking and reporting for proactive compliance management.
- Remain current with laws and regulations related to aggregate spend and identify areas of risk associated with these laws, develop risk mitigation recommendations and collaborate to ensure appropriate implementation of necessary measures.
- Develop, manage and oversee implementation of policies, procedures and processes related to aggregate spend and state reporting.
- Develop and implement effective training and communication initiatives related to aggregate spend and state reporting for senior management, employees, customers and third party vendors.
- Respond to inquiries and manage appropriate proactive communication for HCPs, external parties and internal Endo personnel.
- Develop metrics and key performance indicators that measure effectiveness of the compliance program. Design and support the delivery of reports on findings and facilitate the development of action plans to critical findings.
- Coordinate with Compliance colleagues and support reporting on comprehensive auditing and monitoring program for compliance risk areas and activities.
- Support other critical compliance activities as identified by the Director, Compliance Operations and Privacy.
To qualify for this role, you will possess:
- BS/BA plus Law degree or equivalent advanced degree.
- 5-7 years of experience in pharmaceutical and/or medical device compliance programs.
- Experience with federal and state marketing laws highly preferred.
- Experience with cross-functional teams and demonstrated ability to partner effectively with others to address complex compliance issues.
- Experience developing business requirements and working with business processes to meet these requirements including experience working with IM to translate requirements into technical solutions.
- Working knowledge of various laws, regulations, and industry guidance that affect the corporate-wide compliance program, including federal and state government price reporting laws, fraud and abuse and anti-kickback statutes, OIG and AdvaMed and PhRMA guidelines, state marketing compliance laws, and the PDMA.
- Effective public speaking skills and an ability to communicate in both verbal and written form with employees throughout the company.
- Must possess excellent organizational and planning skills and the capacity to simultaneously handle a variety of complex confidential issues.
- Ability to travel 10-20%
To apply, please follow this link:
http://tbe.taleo.net/NA6/ats/careers/requisition.jsp?org=ENDO&cws=1&rid=2550
Please note: we can only accept resumes via the Careers page of our website.
Endo Pharmaceuticals Inc. recognizes the advantages of a diverse workforce achieved through a commitment to equal employment opportunities
Posted 11/22/2011
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MANAGER, CORPORATE COMPLIANCE - QUALITEST - Endo Pharmaceuticals
Q1-13
Endo Pharmaceuticals is a U.S.-based, specialty healthcare solutions company, focused on high-value branded products and specialty generics. Endo is redefining its position in the healthcare marketplace by anticipating and embracing the evolution of health decisions based on the need for high-quality and cost-effective care. We aim to be the premier partner to healthcare professionals and payment providers, delivering an innovative suite of complementary diagnostics, drugs, devices and clinical data to meet the needs of patients in areas such as pain, urology, oncology and endocrinology. For more information about Endo Pharmaceuticals, and its wholly owned subsidiaries American Medical Systems, HealthTronics Inc., and Qualitest, please visit www.endo.com
To support our critical business strategies, we are currently seeking a Manager Corporate Compliance and Business Practices to join our Corporate Compliance and Business Practices team. This role will be located at our Qualitest facilities in Huntsville, Alabama.
Reporting to the Director, Corporate Compliance, the Manager, Corporate Compliance & Business Practices, has direct responsibility for the operational excellence and enhancement of the Corporate Compliance Program within the Qualitest generic pharmaceuticals business unit. The Manager Compliance will influence and operationalize the company's Corporate Compliance Program within the Qualitest generic pharmaceuticals business unit.
As the Manager, Corporate Compliance and Business Practices, your responsibilities will include supporting and assisting the Corporate Compliance & Business Practices Department in carrying out these roles and responsibilities specifically:
- Develop and implement the annual and long-term strategic compliance plans that reflect the seven elements of an effective compliance program.
- Ensure that all Corporate Compliance Program policies, procedures, training, auditing and monitoring are in place for the generic pharmaceuticals business and investigate allegations of non-compliance related to the business.
- Develop collaborative relationships with key stakeholders. Advise clients as it relates to compliance with applicable policies and procedures.
- 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; False Claims Act and Anti-Kickback statute; OIG, PhRMA and AdvaMed guidelines; state and federal marketing compliance laws; Foreign Corrupt Practices Act and other anti-bribery laws; and privacy laws.
To qualify for this role, you will possess:
- BA/BS required, J.D. degree or equivalent preferred
- 5 - 7 years relevant experience
- Effective public speaking skills and an ability to communicate in both verbal and written form with employees at all levels, including members of Senior Management team.
- Excellent organizational and planning skills and the capacity to simultaneously handle a variety of complex confidential issues, as well as an ability to work independently with limited direct supervision.
- Proven ability to lead change and create infrastructure.
- Experience in pharmaceutical or other regulated manufacturing environment.
- Thorough understanding of generic pharmaceutical business and related compliance issues, including but not limited to federal and state government price reporting laws; False Claims Act and Anti-Kickback statute; OIG guidelines; state and federal marketing compliance laws; Foreign Corrupt Practices Act and other anti-bribery laws; and privacy laws.
- Ability to travel 25%
To apply, please follow this link:
http://tbe.taleo.net/NA6/ats/careers/requisition.jsp?org=ENDO&cws=1&rid=3593
Please note: we can only accept resumes via the career portal of our website.
Endo Pharmaceuticals Inc. recognizes the advantages of a diverse workforce achieved through a commitment to equal employment.
Posted 11/11/2011
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COMPLIANCE MANAGER - RESEARCH & DEVELOPMENT - Forest Laboratories
Click here for complete information and to apply:
http://frx.com/careers/job_description.aspx?number=107944
Posted 11/10/2011
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COMPLIANCE MANAGER - PROMOTIONAL - SALES & MARKETING ACTIVITY - Forest Laboratories
Click here for complete information and to apply:
http://frx.com/careers/job_description.aspx?number=107223
Posted 11/8/2011
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SENIOR MANAGER - COMPLIANCE - Forest Laboratories
Click here for complete information and to apply:
http://frx.com/careers/job_description.aspx?number=107214
Posted 11/8/2011
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SYSTEMS & REPORTING SPECIALIST- Forest Laboratories
Click here for complete information and to apply
http://frx.com/careers/job_description.aspx?number=107827
Posted 11/8/2011
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ASSOCIATE MANAGER, COMPLIANCE - MONITORING - Novo Nordisk
PURPOSE:
Monitor and audit company and individual adherence to Novo Nordisk Policies, Guidelines, Corporate Integrity Agreement, and other defined Federal and state laws and requirements. This role will have responsibilities for: (i) conducting monitoring activities and audits of various company records, (ii) assisting with investigations related to audit findings and allegations of non-compliance with Company policy, (iii) developing and executing on a detailed project plan for quarterly and annual monitoring and auditing activities, (iv) presenting findings to the Chief Compliance Officer and Senior Management, and (iv) preparing regular audit reports and presentations in a form that is standard with the Novo Nordisk Compliance reporting and Corporate Integrity Agreement requirements.
RELATIONSHIPS:
This position reports to the Sr. Manager, Compliance and may take direction from the Chief Compliance Officer. Individual will interact daily with other Compliance staff and external consultants who support Novo Nordisk Compliance auditing and monitoring activities and work closely with counterparts in other Novo Nordisk business areas including Legal, Human Resources, and Sales, Marketing. Establish and maintain external relationships with outside counsel and industry peers.
ESSENTIAL FUNCTIONS:
- Develop and maintain knowledge and understanding of: Novo Nordisk Diabetes and Biopharmaceutical products, industry regulations and guidelines (e.g. Federal Anti-Kickback Statute, False Claims Act), Novo Nordisk policies, procedures, guidelines, and Corporate Integrity Agreement
- Indirectly monitor sales representatives' interactions with Healthcare Professionals and Healthcare Institutions and identify potential compliance violations
- Execute and manage against an audit/monitoring plan to comply with the Novo Nordisk Field Force Monitoring Program (FFMP) and Non-Promotional Monitoring Program (NPMP) in alignment with the Company Corporate Integrity Agreement
- Conduct detailed records review of field sales employees' records and systems relating to interactions with healthcare professionals and institutions. Specifically, perform comprehensive reviews of sample distribution records, time and expense reports, inquiries relating to medical information, call notes, and other relevant records and documentation
- Work with external consultants to review and address the results of live speaker program audits. Prepare reports and present results to the Chief Compliance Officer, managers in the relevant lines of business, and Senior Management
- Work with available documentation associated with consulting arrangements, and medical education grants to ensure compliance with Novo Nordisk Inc policies and procedures
- Review and follow-up on suspected areas of non-compliance of Novo Nordisk Policies and Procedures or of legal or compliance requirements as required
- Work with the Novo Nordisk Compliance Investigations personnel to assist in the investigation of incidents of non-compliance and allegations of violation of Novo Nordisk policies
- Prepare annual Corporate Integrity Agreement audit report regarding activities associated with the Field Force Monitoring Program and Non-Promotional Monitoring Program
- Establish and implement new systems and processes to monitor activities and further the Novo Nordisk Compliance department monitoring and auditing program
- Utilize Novo Nordisk information systems to prepare and execute monitoring operations.
PHYSICAL REQUIREMENTS:
Approximately 10% overnight travel
DEVELOPMENT OF PEOPLE:
Not Applicable
KEY SUCCESS FACTORS:
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
- A Bachelor's degree or equivalent, relevant experience required
- A minimum of 6+ years overall experience with a minimum of 5+ years of pharmaceutical or life sciences experience is required; compliance auditing and/or monitoring experience in the Pharmaceutical or life sciences industry is preferred
- Must possess an in-depth knowledge and understanding of pharmaceutical industry regulations and guidelines (e.g. FDA, PhRMA Code, Federal Anti-Kickback, False Claims, etc.)
- Must possess an in-depth knowledge and understanding of pharmaceutical sales, marketing, and/or product related practices
- Excellent written and verbal communication skills and organization skills are required
- Experience working with or under a Corporate Integrity Agreement preferred
- Strong written and verbal communication skills
- The ability to partner and collaborate effectively with stakeholders
- The ability to think objectively and use sound reasoning principles
To apply, contact AINC@novonordisk.com
Posted 11/8/2011
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MANAGER, COMPLIANCE - Novo Nordisk
PURPOSE:
This position is responsible for managing various aspects of implementing the Company's comprehensive compliance program and its Corporate Integrity Agreement including the development of policies and procedures, preparing presentations and reports, and maintaining registries of information required to meeting government reporting requirements.
RELATIONSHIPS:
Reports to the Associate Director, Compliance Novo Nordisk Inc. Interacts with all Novo Nordisk affiliates, departments and staff within the US and globally. External relationships include interactions with healthcare professionals and vendors that perform services for Novo Nordisk Inc., as well as outside counsel and industry peers.
ESSENTIAL FUNCTIONS:
- Serves as a primary liaison and point of contact for the NNI Line of Business, vendors and other internal and external stakeholders regarding certain Compliance Department programs
- Develops, updates and maintains processes and procedures for identifying Novo Nordisk employees, consultants and vendors required to comply with government mandated training requirements and retaining required documentation around such identified parties
- Utilize Legal Department interpretations to make determinations regarding inclusion of individuals in such registries
- May supervise at least one individual who will be responsible for ensuring that registry information is up-to-date and is maintained in accordance with company procedures
- Coordinates and collaborates with the Compliance Training Group to ensure that individuals who must complete government mandated training completed required training within deadlines
- Leads the development of websites and other tools needed to identify individuals
- Using tools such as Excel and other spread sheet or database applications compare sets of information to the registries and prepare reports for all parts of the company
- Supports the Chief Compliance Officer in setting and accomplishing functional objectives of the Compliance Department, particularly in the area of developing, implementing and improving the company's ability to accurately determine who is a member of each registry
- Maintains effective lines of communication between the Compliance Department and departments within the company
- Assists in the development of reports to the Compliance Committee, the Committee of the NNI Board of Directors and the federal government. Produces written materials and presentations as necessary summarizing the registries and associated issues
PHYSICAL REQUIREMENTS:
Travel required, approximately 15% estimated
DEVELOPMENT OF PEOPLE:
- Ensure that reporting personnel have 3P forms with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process
- Ensure that the IDP forms include completed Learning and Aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility
- Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way of Management
KEY SUCCESS FACTORS:
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
- A Bachelors Degree or equivalent, relevant experience required
- A minimum of 8 years overall experience, with 4+ years of legal, regulatory or compliance experience in the pharmaceutical industry
- Demonstrated mastery of Excel and other spread sheet or database tools
- Demonstrated strong interpersonal skills (must have working relationships with employees at all levels of the organization and employees must feel comfortable communicating with this position)
- Demonstrated track record of success in impacting and influencing senior management
- Effective time management skills. Ability to handle multiple projects simultaneously
- Strong communications skills - (1) able to effectively communicate information to employees across all levels of the company; (2) ability to persuasively explain and support positions to senior management
- Uncompromising ethics and high standard of personal integrity
Department North America - Compliance (3)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 10 - 20%
To apply, contact AINC@novonordisk.com
Posted 11/8/2011
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SENIOR MANAGER, COMPLIANCE - Novo Nordisk
Manage, develop and participate in the planning and implementation of the monitoring and auditing functions for the Compliance Department at Novo Nordisk Inc, to ensure compliance with policies, guidelines and the laws and regulations that impact marketing, sales and research at Novo Nordisk Inc. Ensure that monitoring operations of various company records, reports, and areas of Sales, Marketing and Medical are designed, developed and operational; and ensure audit plans for specified operations within these areas are developed and executed on a regular schedule, and the results of any monitoring or auditing are made available to the line of business and others with responsibility for maintaining compliance within the Company. Follow-up and assist with any necessary activity to ensure compliance with Company policy and the laws and regulations that impact the area under review.
RELATIONSHIPS:
This position:
- Is responsible for managing the activities of at least one employee
- Reports to the Chief Compliance Officer or his/her designee
- Interacts daily with other Compliance staff
- Works collaboratively with counterparts in other Novo Nordisk business areas and departments, especially Legal, Human Resources and IT
- Establishes and maintains external relationships with industry peers
ESSENTIAL FUNCTIONS:
- Identify areas of risk at Novo Nordisk Inc. and manage and assists in the development of monitoring or auditing plans that will mitigate risks and help build upon our Company's culture of compliance and "Doing the Right Thing" in furtherance of the Novo Nordisk Way
- Manage, design and implement monitoring operations to detect potential violations of Company policy and the laws and regulations that impact the pharmaceutical industry
- Develop audit plans to study various functions within Sales, Marketing and Medical and personally carry out the audits or manage internal or external auditors and ensure completion of the tasks required by the audit plans
- Report the results of the monitoring operations and any audits to senior management and line of business for the area under review
- Work with the audited or monitored areas and follow-up on any areas that require corrective action
- Interface and collaborate effectively with Legal, Human Resources, Finance, NNAS Group Internal Audit and other relevant departments as required
- Prepare reports of monitoring operations and any audit findings
- Provide assistance to Novo Nordisk colleagues in other departments as appropriate
PHYSICAL REQUIREMENTS:
Approximately 15% overnight travel
DEVELOPMENT OF PEOPLE:
- Ensure that reporting personnel have 3P forms with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process
- Ensure that the IDP forms include completed Learning and Aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility
- Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way
KEY SUCCESS FACTORS:
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
- A Bachelor's degree required
- A minimum of 8 years overall experience, with 4+ years experience in the development of monitoring operations, and planning and conducting audits within the pharmaceutical industry required
- Some supervisory experience preferred
- Excellent communication skills (written and verbal) and organization skills are required
- The ability to partner and collaborate effectively with stakeholders
- The ability to think objectively and use sound reasoning principles
Department North America - Compliance (1b)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 10 - 20%
To apply, contact AINC@novonordisk.com
Posted 11/8/2011
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