The Pharmaceutical Compliance Forum

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EMPLOYMENT OPPORTUNITIES

 

SENIOR MANAGER, COMPLIANCE OPERATIONS - Jazz Pharmaceuticals
Job Location: US-PA-Philadelphia
Job ID: 2018-3959

Overview
Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.

Our therapeutic areas of focus include sleep and hematology/oncology - areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.

We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals.

Position Profile
Brief Description:
The Senior Manager, Compliance Operations is a critical member of the Compliance Operations team. This position is responsible for leading the implementation of various special projects as directed by the Deputy Chief Compliance Officer and Chief Compliance Officer. Such projects include implementing special audit protocols, overseeing development of significant new policies and processes and development of new training programs, some or all of which are driven by changes in the external risk environment or new regulatory requirements. The successful candidate will develop and implement the overall project plans for these projects and assign tasks and monitor progress against those tasks as well as prepare reports summarizing status and progress of such projects.

Essential Functions
The Senior Manager, Compliance Operations serves as a day-to-day project manager for implementation and oversight of special projects which may be driven by changes in external risk environment or new regulatory requirements, including:

  • Ensuring appropriate policies and procedures are implemented;
  • Ensuring that training and education occurs consistent with the special project plan;
  • Assisting the Deputy Chief Compliance Officer and the Chief Compliance Officer in developing and implementing a risk assessment and mitigation program;
  • Assisting the Deputy Chief Compliance Officer in reviewing and enhancing the Company's process to conduct appropriate screening and background checks for employees, contract workers and vendors, where appropriate; and
  • Assisting the Deputy Chief Compliance Officer and the Chief Compliance Officer in the preparation of reports summarizing any of the special projects overseen by the Senior Manager, Compliance Operations.

Required Knowledge, Skills, and Abilities

  • Significant knowledge and understanding of compliance matters, particularly with regard to interaction with healthcare professionals, fraud and abuse, anti-kickback and other compliance matters.
  • Ability to develop and effectively implement a project plan across the company and ensure adherence to budgets, schedules, work plans and performance requirements.
  • Ability to oversee and manage cross-functional issues and projects with team members at all levels of the organization.
  • Ability to resolve a wide range of issues in creative ways.
  • Ability to assign tasks, set deadlines and monitor and summarize progress of completion of those tasks.
  • Ability to change the thinking of or gain acceptance from others in sensitive situations, without damage to the relationship.
  • Ability to prioritize conflicting demands and priorities and manage heavy workload.
  • Ability to manage external consultants and vendors engaged to assist in conducting special projects.
  • Team player with strong interpersonal skills.
  • Strong oral and written communication skills.
  • Ability to work collaboratively and independently as the circumstances require.
  • Self-motivated and detail-oriented.
  • Position may be based in Philadelphia, PA or Palo Alto, CA.
  • Solid organizational skills including attention to detail and multitasking skills.

Required/Preferred Education and Licenses

  • Bachelor's degree required.
  • Minimum of 3 years' industry-related experience in healthcare corporate compliance with demonstrated ability to manage complex projects and teams.
  • Experience working under a corporate integrity agreement preferred.

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

 Apply here
Posted 11/30/2018

DIRECTOR/COMPLIANCE COUNSEL - Heron Therapeutics
Location: San Diego, CA

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

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.

Send resume to: jobs@herontx.com.
Posted 11/29/2018

MANAGER, COMPLIANCE - Horizon Pharma
Lake Forest, IL

Working at Horizon Pharma is more than a job - it's personal. We define success by a different set of numbers: the number of lives touched, the number of lives changed, the number of lives saved. We're a team of agile, out-of-the-box thinkers who are inspired to do more because we know we're a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help patients live up to theirs.

Seeking an experienced compliance professional responsible for supporting Horizon's compliance department.The Manager, Compliance possess working knowledge of the current healthcare compliance environment and pharmaceutical industry.This role will be responsible for global transparency reporting obligations for the organization as well as compliance data analytics. In addition, the role will assist with compliance program operations and provide policy guidance to the business.

Job Description

  • Manage the company's aggregate spend system and ensure applicable data are being captured and accurately reported for international, federal and state government transparency reporting purposes.
  • Conduct aggregate spend system training for employees and vendors.
  • Perform data analytics, data correction, and associated remedial action.
  • Leverage aggregate spend data and additional company data sources to create compliance data monitoring dashboards and executive reports.
  • Assist in development of policies and work instructions to reflect the processes associated with aggregate spend reporting and data analytics.
  • Conduct field ride alongs and speaker program observations to monitor key compliance risk areas. Draft observation reports and identify corrective actions
  • Provide advice and support to Sales, Marketing, Commercial Operations and other key business stakeholders.
  • Assist in developing compliance training, compliance policy development, investigations, and auditing, as needed.
  • Other duties as assigned.

Qualifications and Skills Required:

  • Experience in the healthcare industry and experience with transparency reporting
  • Strong MS Excel skills required
  • Organized, analytical, and attention to detail required
  • Ownership driven with a sense of urgency
  • Ability to communicate and work effectively within a team, cross-functionally, and with leadership
  • Must also be comfortable as a self- starter, creative thinker, and independent worker
  • Ability to multi-task and be flexible in a changing and fast paced environment
  • Comfortable speaking in public.

Horizon Pharma plc does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.

 Apply here
Posted 11/28/2018

MANAGER - GOVERNMENT ACCOUNTABILITY - Novo Nordisk


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

The Position
This position is responsible for supporting the daily operational activities related to the Ethics & Compliance (E&C) Department's Government Accountability Program ("Program"). This position will be directly engaged with reviewing compliance with Federal PDMA obligations, local/state sample obligations, Drug/Sharp takeback compliance, and associated reporting. The position will also support other Programs as required. Additionally, this position will serve as the point of contact for E&C Department systems to interface with other Line of Business ("LoB") systems, ensuring compliance objectives are met and coordination between them to ensure the Program's effectiveness.

Relationships
Reports to the Director - Government Accountability. Regularly interacts with all other functional E&C areas and LoB (e.g. Legal, Information Technology, Commercial Effectiveness, Clinical Operations, and Marketing Effectiveness). The position will also interact with external customers including Health Care Professionals (HCP), third party/external vendors, and external consultants. This position may interact with government officials. This position may manage employees in Novo Nordisk Inc (NNI's) Global Servicing Center in Bangalore.

Essential Functions

  • Supports the Director - Government Accountability in facilitating and raising awareness of the Program while fostering accountability for E&C program throughout the organization
  • Maintains understanding of laws and regulations, enforcement actions and evolving practices relevant to pharmaceutical ethics & compliance and proposes updates to the Program, as appropriate
  • Manages the review and timely reporting of all government requirements while understanding NNI, local and global impacts
  • Responsible for creating and executing an Organizational Change Management (OCM) Plan for the Government Accountability programs
  • Informs management of ethics & compliance issues in a timely manner while encouraging the flow of information between colleagues and LoB
  • Actively works to identify, analyze, and mitigate potential business ethics and other risks to the organization
  • Supports the Director with Business Assurance (BA) and Business Ethics & Compliance Office (BECO) collaborations regarding government requirements and integration of systems/data
  • Supports NN affiliates (e.g., NNCI) with implementing and maintaining a government accountability program
  • Recommends enhancements to systems, processes and technologies for government reporting
  • Manages creation and continued maintenance of government accountability protocols and assumption documents to support accurate filings and internal documentation
  • Conducts training to employees and third party vendors to timely communicate new government requirements or updated NN interpretations
  • Supports the government accountability budget (e.g. forecasting expenditures, reporting variances, and ensuring responsible spending) as requested
  • Maintains understanding of applicable laws and regulations, enforcement actions and evolving practices/trends relevant to pharmaceutical compliance
  • Responsible for development of annual plan to strengthen NNI's confidence when attesting to government reports (e.g., sample transparency, compliance program attestations). Support remediation and mitigation activities as they relate to Government Accountability Ensure that controls are in place for reporting completeness, consistency, accuracy, and integrity to strengthen and support the sub-certification/attestation process
  • Responsible for ensuring that E&C senior management is informed of compliance issues in a timely manner
  • Additional responsibilities with Government Accountability or departmental operational impact as assigned

Physical Requirements
0-10% overnight travel required.

Qualifications

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

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

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

 Apply here
Posted 11/26/2018

ETHICS AND COMPLIANCE MANAGER NA - Ipsen

Company Profile
Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company, focused on innovation and specialty care. At Ipsen, we've created a workplace that recognizes and promotes an entrepreneurial spirit in our employees, and are building a strong legacy of helping patients with difficult-to-treat diseases across oncology, neurosciences and rare diseases. We know we can only be better and smarter if we work diligently together as ONE Ipsen, across all functions and geographies. We strive to break down silos and empower teams to deliver effective therapeutic solutions through highly differentiated medicines for patients with unmet needs.

We take pride in our culture, which is rooted in collaboration, to deliver results for our core customer - the patient. This level of involvement by cross-functional teams promotes a strong sense of unity, and pulls together all colleagues locally and across our key geographies, which span 115 countries across North America, Europe and Asia. As a growing organization, Ipsen North America is comprised of our Cambridge, MA, Basking Ridge, NJ and Toronto, Canada locations, with employees supporting functions including Commercial Operations, R&D, Business Development and Technical Operations.

Our employees are the driving force behind our mission at Ipsen, and to sustain their passion and focus every day, we offer a wealth of fulfilling challenges and growth opportunities through unique leadership and training programs. At Ipsen, you will work alongside industry leaders and contribute within a fast-moving and truly game-changing global organization, recognized for its talent and patient solutions. At Ipsen, we're making hope a reality for the patients we serve.

Position Summary
This position is responsible for managing compliance processes, including the preparation, communication, implementation and monitoring of adherence to, policies and standards to promote compliance with legal and regulatory requirements. Provides compliance advice and support to the company, its subsidiaries and affiliates. Performs a variety of investigations, and follows-up on others, through resolution. Leads and/or participates in other compliance projects, as needed. The individual should enjoy working collaboratively with other functional areas and also be comfortable with a significant degree of autonomy. This is a great opportunity to be an integral part of a dynamic Ethics and Compliance group.

Essential Functions
  Responsibilities
  Responsibilities will include, but are not limited to, the following:

  • Oversee implementation of compliance recommendations, including those that result from due diligence findings
  • Lead risk assessments, work with internal audit to review program compliance, and utilize analytics to monitor it, identify areas of risk and prioritize risk mitigation
  • Proficiency on federal, state and global legal/regulatory requirements and timely responds to field inquiries
  • Work closely with the Transparency team to advise on compliance implications under the Sunshine Act
  • Lead on implementation of compliance recommendations and documentation/records for commercial programs and initiatives
  • Review and prepare documentation related to Anti-kickback and Sunshine controls - contracts and forms review
  • Maintain library of anti-kickback and Sunshine compliance forms and provide them to operations for consistency
  • Prepare dispute resolution procedures and advise on process
  • Publish periodic FAQs and commercial guidance, as appropriate
  • Lead training initiatives, and develop the respective materials within areas of responsibility
  • Create guidelines and tools, and advise different cross-functional teams to ensure compliance
  • Assist with other compliance work as needed (may involve international matters)
  • 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, fraud and abuse and anti-kickback statutes, OIG guidelines, industry codes in relevant markets including PhRMA, US state marketing compliance laws, FCPA, UK Bribery Act, and other anti-bribery laws.

Qualifications
  Education and experience

  • Bachelor's degree in related discipline.
  • 5 + years of increasing responsibility and complexity in terms of any applicable professional experience
  • 2-4 years of compliance experience
  • Law degree a plus
  • Graduate degree a plus
  • Pharmaceutical industry experience required

Core Competencies (Specific knowledge, skills and abilities that enable an individual to effectively perform the job)

  • Strong management skills and ability to attract, retain, motivate and develop junior team members for high performance
  • Excellent verbal and written communication skills and ability to resolve disputes effectively
  • Strong presentation and public speaking skills
  • Ability to manage projects, risks, cost, time and project teams
  • Work effectively with team members to achieve company goals in effective ways
  • Strong planning and organizational skills and techniques
  • Communicate effectively with management
  • Good negotiating skills
  • Build strong relationships, understand organizational complexities and manage conflict
  • Broad professional and managerial skills with an understanding of industry practices and company policies and procedures

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

Ipsen Biopharmaceuticals, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law.

Ipsen Biopharmaceuticals, Inc. conducts background screening, reference checks, and drug testing as part of its pre-employment screening process. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned.

All Employees are expected to adhere to all company policies and act as a role model for company values.

Note: This description is not intended to be construed as an exhaustive list of duties, responsibilities or requirement for the position. This position may change at any time and the employee may be requested to perform different or additional duties as assigned.

 Apply here
Posted 11/19/2018

CORPORATE COMPLIANCE DIRECTOR - Indivior
Location: Slough


Indivior is a global specialty pharmaceutical company with a 20-year legacy of leadership in patient advocacy, health policy and evidence-based best practice models that have revolutionized modern addiction treatment. The name is the blend of the words individual and endeavor, and the tagline "Focus on you" makes the company's commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction - a chronic relapsing disease.

Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. The company has a strong pipeline of products and candidates designed to both expand on its heritage in global opioid dependence and address other chronic diseases of addiction - including opiate overdose, alcohol use disorders and cocaine intoxication - as well as related mental health disorders such as schizophrenia.

POSITION SUMMARY:
The Director, EMEA Corporate Compliance will be responsible for managing, enhancing and implementing Indivior's EMEA corporate compliance program and establishing clear policies and offering pragmatic guidance to the EMEA Area Business to help ensure compliance with applicable EU and local country laws, regulations and industry codes.

ESSENTIAL FUNCTIONS:

  • Leading the development, maintenance and evolution of policies, procedures and controls to help ensure compliance with Anti-Bribery and Anti-Corruption regulations and practices.
  • Developing, maintaining and disseminating EMEA Area Business corporate compliance policies, procedures and guidance materials, consistent with the Company's corporate compliance policies and guidelines, the Code of Business Conduct and underlying policies, other standard operating procedures, and pharmaceutical industry guidelines and best practices. This role will ensure alignment to local country requirements where appropriate ("Company Policies").
  • Participating or overseeing third-party due diligence assessments and monitoring processes for commercial distributors and other business partners.
  • Development and implementation of educational training programs on such EMEA and local country policies in appropriate language, along with monitoring completion of educational training programs.
  • Monitoring the EMEA Area Business functional leaders' compliance with Company Policies.
  • Facilitating and coordinating the development, maintenance and dissemination of other educational training content developed by members of the Corporate Compliance & Legal Departments.
  • Monitoring and assessing business practices and activities for compliance with Company Policies and assisting with the development and implementation of process and control enhancements.
  • Staying abreast of changes in pharmaceutical industry compliance standards for purpose of assessing and adopting changes to existing EMEA Area Business corporate compliance policies and SOPs.
  • Overseeing and providing Compliance certification of the Company's analysis and submission of payment reporting obligations and adherence to ABPI and EFPIA transparency requirements across EMEA business.
  • Chairing, participating and managing the EMEA Area Business's Compliance Committee and any local compliance committees.
  • Reporting of compliance matters to the Compliance Committee and Senior Management.
  • Carrying out other tasks and activities related to the development, execution and maintenance of the EMEA Area Business's compliance program.
  • Ensuring compliance across a wide geographic region with country variances
  • Providing pragmatic approach to deliver solutions in a commercial environment within a compliance framework
  • Implementing and driving compliance from regional to country level understanding within global framework of Indivior Code of Conduct.

MINIMUM QUALIFICATIONS:

  • BA (Hons) or BSc(Hons) 2.1 or above, educated
  • Law Degree not required, but is preferred
  • Minimum 7-10 years of experience in either the pharmaceutical or medical device industry including a minimum of 5 years in a senior or regional healthcare compliance role, with some personnel management responsibility
  • Detailed understanding of government regulations governing healthcare compliance programs.
  • Specific programmatic experience developing or executing Antibribery and Anti-Corruption compliance program
  • Ability to work closely and collaboratively with other business functions and Departments.
  • Strong project management skill set and a consistent driver of the change management process.
  • Experience in leading, planning, and conducting reporting on monitoring activities.

COMPETENCIES/CONDUCT:
In addition to the minimum qualifications, the employee will demonstrate:

  • Flexibility in thinking and pragmatic problem-solving skills
  • Excellent interpersonal, communication and presentation skills.
  • Strong influencing skills and ability to exercise sound business judgment
  • Ability to work independently and manage a diverse and demanding workload.
  • Willingness to work in a dynamic, fast-paced environment.
  • High standards of professional integrity and independence.
  • Able to effectively influence senior management and functions to drive change and improvement
  • Displays a high sense of urgency
  • Flexible to travel if required
  • Tenacity and robustness
  • The business language in Indivior is English, fluency in local languages advantageous

GUIDING PRINCIPLES:
Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.

The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.

EQUAL EMPLOYMENT OPPORTUNITY
EOE/Minorities/Females/Vet/Disabled

 Apply here
Posted 10/30/2018

DIRECTOR, COMPLIANCE OPERATIONS - Insmed
Department Name: Global Compliance
Manager Name & Title: Tiffany Cumming-Damiani, Executive Director, Corporate Compliance, Policies and Training
Effective Date: May 31, 2018 (updated Oct 5 2018)


Supervision of Others: (internal/external):

  • This position reports directly to the Executive Director, Corporate Compliance, Policies and Training
  • This is a non-supervisory position at this time and may change as the Global Compliance function grows.

General Purpose of Role:
With the Executive Director, Corporate Compliance, Policies and Training, implement and manage compliance operations functionality for Insmed's Global Compliance group and to provide guidance to Insmed's US and global (EU, Japan) operations. This role will be based at our Bridgewater, New Jersey headquarters location.

Responsibilities: Following is a list of essential duties, functions and responsibilities.

  • Implement and manage day-to-to operations for the hiring of healthcare professionals including process development, software implementation, fair market value and lifecycle management
  • Implement and manage US transparency program with scalability to global, including oversight of outsourced reporting vendor
  • Support policy and process development, updates and translations as assigned along with any training or communications
  • Partner with the US, EU and Japan businesses to provide guidance and support as needed
  • Provide guidance and support to US business
  • Identify continuous improvement activities to continue to enhance and grow the compliance function
  • Lead remediation efforts as needed, resulting from compliance monitoring and auditing

Position Requirements:

Knowledge & Experience

  • Knowledge of US and global compliance regulations, laws and standards
  • Experience working globally (EU, Japan)
  • Experience in engaging healthcare professionals processes
  • In depth knowledge of US transparency laws and reporting processes
  • Experience in developing and implement compliance processes and software (e.g. hiring healthcare professionals' software, third party due diligence software)
  • Experience in continuous improvement for compliance programs

Qualifications

  • Bachelor's degree required; advance degree preferred.
  • Compliance certification is a plus
  • At least 10 years' experience in corporate compliance for a pharmaceutical or biotech company

Skills

  • Must have excellent communication skills (verbal and written).
  • Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
  • Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).

Other (if applicable):

  • Domestic and international travel may be required occasionally (5-10%)
  • Must successfully exhibit Insmed's five (5) core corporate competencies of: Excellence, Accountability, Driven, Collaborative and Solutions; along with any other position specific competencies.
  • Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.

 Apply here
Posted 10/30/2018

ASSOCIATE DIRECTOR - ETHICS & COMPLIANCE OPERATIONS - Novo Nordisk

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

The Position
This position leads and manages the development and implementation of the U.S. healthcare ethics and compliance program function for compliance and department operations including department strategy, business planning, affiliate support and other key department processes. This position performs special projects, assists in development and execution of Ethics & Compliance (E&C) plan across functions/organizational lines, and provides additional leadership in Ethics and Compliance Department as requested.

Relationships
Reports to the Senior Director, Ethics & Compliance Operations, Monitoring & Auditing (M&A), and Government Accountability. Manages two or more Novo Nordisk Inc (NNI) E&C professionals and dedicated compliance professionals in Global Service Center (GSC), Bangalore. Internal relationships include in-house legal counsel, global compliance colleagues, senior leaders throughout lines of business. Supports North American affiliates (e.g. NNCI, NNRCSI). External relationships include vendors and consultants as well as developing and maintaining relationships with the broader E&C network within the industry.

Essential Functions

  • Supports the Senior Director in facilitating and raising awareness of the E&C program while fostering accountability for compliance throughout the organization
  • Fosters a continuous improvement mindset and proposes enhancements to the E&C program, informed by industry trends and best practices
  • Champions a proactive approach to E&C that is focused on partnership, prevent and risk mitigation
  • Participates in industry associations and engagements to raise the profile of the E&C Program
  • Operationalizes and implements holistic processes for business planning that ensures coordination of 1/3/5 year E&C and NNI milestones
  • Provides strategic E&C and operational support and guidance for North America affiliates related to ethics and compliance broadly, including relevant reporting requirements
  • Runs projects of varying size both within E&C and across NNI
  • Development and implementation of efficient systems, processes, and technologies to meet operational requirements (e.g., Exclusions processes, contracts, TPRs,)
  • Operationalizes key initiatives with the global Business E&C Office by supporting the strategic annual operations plan while understanding global and local impact
  • Creates annual plan for and manages GSC Bangalore office
  • Responsible for proactively identifying additional off shore/near shore work opportunities or enhancements
  • Provides direction for department operations functions, including planning key meetings, department wide development opportunities, and other functions
  • Works collaboratively with the Strategy & Education groups to support the development, implementation and maintenance of platforms and tools for employees and third parties to access company standards related to E&C
  • Ensures that the Circle of Excellence (COE) works cross-functionally to collaborate with business leaders to ensure that Standard Operating procedures (SOPs) are developed and implemented, as appropriate, to help enable the implementation of NNI's E&C policies
  • Continuously supports the enhancement of E&C communications, education and training
  • Creates content for key E&C Department meetings (e.g. off-sites, lunch & learns)
  • Manages E&C department related HR processes (e.g. JD updates, career frameworks)
  • Responsible for E&C department educational activities
  • Management of department budget and contracting processes, including forecasting expenditures and establishing practices that promote and support responsible spending, tracking and rationale regarding allocation
  • Manages the annual certification processes
  • Administrative support for the entire E&C Department
  • Provides additional support to the Government Accountability and E&C M&A functions as requested

Physical Requirements

  • 10-15% overnight travel required.

Development of People

  • Supervisory

Qualifications

  • A Bachelor's degree from an accredited institution is required. Additional education/certification within the compliance and health-care related fields is preferred
  • A minimum of 10+ years combined pharmaceutical, legal, regulatory, and compliance experience required OR 8+ years' experience if accompanied by an advanced degree or certification (e.g. MBA, JD, PMP)
  • Uncompromising ethics and high standard of personal integrity
  • Experience working under a government agreement (e.g. CIA, DPA, Consent Decree) is required
  • Demonstrates strong interpersonal skills and exceptional ability to influence at all levels of the organization
  • 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 and other prosecution agreements with other pharmaceutical companies, PhRMA code and other relevant federal and state aggregate spend reporting requirements, and the current activities and developments involving pharmaceutical sales and marketing required
  • Demonstrated knowledge and clear understanding of the required elements of effective ethics and compliance programs as outlined in the Health & Human Services (HHS) Office of Inspector General (OIG) Compliance Program Guidance and the US Federal Sentencing Guidelines
  • Demonstrated ability to build and maintain effective strategic relationships and networks with internal and external stakeholders
  • Demonstrated ability to manage and lead change in a large, matrix organization
  • Effective time management skills
  • Communicates effectively with different audiences and in different contexts
  • Ability to drive multiple projects to completion meeting internal and external deliverables with high degree of accuracy
  • Prior experience managing professionals required
  • The ability to think objectively and use sound reasoning principles
  • Demonstrated strong interpersonal skills and ability to influence at all levels of the organization
  • Proficiency in MS Office Suite

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

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
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Posted 10/27/2018

ASSOCIATE DIRECTOR - ETHICS & COMPLIANCE RISK & MITIGATION - Novo Nordisk

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

The Position
This position supports the Director, E&C Strategy, Risk & Education with regard to the planning, design, and enablement of the NNI Ethics & Health Care Compliance Program strategy, as well as all aspects of the ethics and compliance risk management process. This position executes and supports the implementation of the Novo Nordisk Inc. ("NNI") Risk Assessment and Mitigation Program and is responsible for the management, tracking, and reporting of Ethics & Compliance ("E&C") risk assessments and the associated mitigation/remediation activities. This position also performs special projects within the department as requested.

Relationships
Directly supports the Director - Planning, Designing, and Enablement with regard to the execution of the Ethics & Compliance program. Closely collaborates with NNI's in-house legal counsel, other leaders across lines of business, and is a member of cross-functional teams throughout NNI. External relationships include vendors, outside counsel, industry peers, and government agencies.

Essential Functions

  • Raises awareness of the program and fosters accountability for ethics and compliance throughout the organization
  • Fosters a continuous improvement mindset and proposes enhancements to the Program informed by industry trends and best practices
  • Champions a proactive approach to ethics and compliance that is focused on partnership, prevention and risk mitigation
  • Participates in industry associations and engagements to raise the profile of the E&C Program and the company
  • Supports the Director in working with the CECO to ensure implementation of any external government reporting requirements
  • Supports Director in designing collaboratively NNI's ethics and compliance risk assessment process, framework, and methodology
  • Supports Director in leading collaboratively the implementation of ethics and compliance risk assessments
  • Supports Director in developing and driving a consistent definition of "ethics and compliance risk" across the organization
  • Supports Director in working collaboratively with ethics and compliance risk assessment cross-functional team members to identify, prioritize, and assign accountability for managing ethics and compliance risks throughout NNI's operations
  • Supports Director in working collaboratively with NNI's cross-functional ethics and compliance risk management stakeholders to develop risk mitigation plans and strives to hold risk owners accountable for action plan delivery and implementation
  • Supports Director in identifying and reporting high-level trends and insights to E&C peers and the broader organization; develops reports for executive leadership and multiple oversight committees
  • Supports Director in working closely with data gathering functions in other departments and identifies opportunities to leverage existing data sets for improved ethics and compliance trending and analytics
  • Supports Director in overseeing the implementation of mitigation plans and processes to facilitate appropriate triage, follow-up and close-out of identified health care compliance issues across all NNI products, therapeutic areas and functional areas
  • Supports Director in championing the implementation of new technologies to aid the risk assessment and mitigation process
  • Supports Director in actively overseeing stakeholder engagement, builds and maintains strategic relationships throughout NNI, and navigates the organization to facilitate risk assessment and mitigation efforts
  • Supports Director in working collaboratively with internal audit and monitoring functions to incorporate risk assessment results and emerging trends into auditing and monitoring plans

Physical Requirements

  • 0-10% overnight travel required.

Qualifications

  • A Bachelor's degree from an accredited institution is required. Additional education/certification within the compliance and health-care related fields is preferred
  • A minimum of 10 years combined pharmaceutical, legal, regulatory, and compliance experience required OR 8 years' experience if accompanied by an advanced degree or certification (e.g. MBA, JD, PMP)
  • Prior experience working under a government agreement (e.g. CIA, DPA, Consent Decree) required
  • Strong health care compliance background and clear understanding of elements of an effective ethics and compliance program
  • Maintains understanding of laws and regulations, enforcement actions and evolving best practices relevant to pharmaceutical ethics & compliance and proposes updates to Ethics & Compliance program, develops plan and deliverables to inform relevant internal functions
  • Uncompromising ethics and high standard of personal integrity
  • Excellent written and verbal communication and interpersonal skills required. Ability to interact with all levels of the business
  • Handles confidential information with discretion and uses information to inform strategic thinking and approach to compliance matters
  • Demonstrated ability in leadership/collaboration skills with the ability to develop and communicate a vision and engage people in that vision
  • Demonstrated ability to display expert level critical thinking in applying principles, theories and concepts on a wide range of problems
  • Demonstrated ability in creating strategic direction, plans and proven ability to drive and sustain business improvement and results
  • Communicates effectively with different audiences and in different contexts
  • Proficiency in Microsoft Office Suite

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

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
 Apply here
Posted 10/27/2018

MANAGER - ETHICS AND COMPLIANCE MONITORING & AUDITING - Novo Nordisk

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

The Position
This position is responsible for executing against the Novo Nordisk Inc (NNI) Ethics and Compliance (E&C) Department's annual Monitoring & Auditing (M&A) strategic plan. This role will conduct monitoring activities and audits of various company records, manage the development and implementation of remediation processes, assist with investigations related to audit findings and allegations of non-compliance with Company policy, preparing regular reports and presentations in a form that is consistent with internal and external reporting requirements.

Relationships
Reports to the Associate Director - Monitoring & Auditing or designee. Closely collaborates with NNI's in-house legal counsel, leaders across lines of business, and is a member of cross-functional teams throughout NNI. The position will also interact with external customers including Health Care Professionals (HCP), third party/external vendors, and external consultants. This position may interact with government officials. This position may manage employees in NNI's Global Servicing Center in Bangalore.

Essential Functions

  • Support the Associate Director, Monitoring & Auditing in facilitating and raising awareness of the Ethics & Compliance program while fostering accountability for compliance throughout the organization
  • Maintain understanding of laws and regulations, enforcement actions and evolving practices relevant to pharmaceutical compliance and proposes updates to ethics & compliance program, as appropriate
  • Identify, analyze, and mitigate potential business ethics risks to the organization
  • Support the development and manage the implementation of a robust health care compliance monitoring and auditing plan
  • Develop and maintain knowledge and understanding of: (1) Novo Nordisk Diabetes, Obesity, and BioPharm disease state and products, (2) industry regulations and guidelines (e.g., laws and regulations regarding pharmaceutical advertising and promotion, Federal Anti-Kickback Statute, False Claims Act, PDMA), Novo Nordisk policies and procedures, and government reporting requirements as needed
  • Develop and manage protocols, guidelines and associated internal communication and documentation related to E&C testing and monitoring
  • Develop and manage the remediation and mitigation process on for the M&A team
  • Manage the full cycle of assigned review processes (e.g. management of third party vendors)
  • Review records and systems relating to interactions with healthcare professionals and institutions, conduct field monitoring visits and monitor various company-sponsored activities to ensure adherence with relevant laws, regulations, industry codes, and company policies
  • Support E&C audits for North America and NN affiliates (e.g. NNRCSI, Business Ethics & Compliance Office (BECO), LatAm) in support of annual auditing plan and/or ad hoc audits as requested
  • Review and follow-up on suspected areas of non-compliance and collaborate with NNI Ethics & Compliance teams as needed
  • Collaborate with compliance colleagues and line of business to help develop and implement remediation and mitigation plans
  • Prepare quarterly and ad hoc reports and presentations summarizing monitoring and auditing monitoring

Physical Requirements

  • 20-30% overnight travel required.

Qualifications

  • A Bachelor's degree from an accredited institution required
  • A minimum of 8 years combined pharmaceutical, legal, regulatory, and compliance experience required OR a minimum of 6 years' experience required if accompanied by an advanced degree or certificate (e.g. MBA, JD, PMP)
  • Demonstrated knowledge and understanding of the Anti-Kickback Statute and False Claims Act, Food and Drug Administration (FDA) rules and regulations regarding the promotion of pharmaceuticals, corporate integrity agreements, PhRMA code, and other relevant reporting requirements
  • Compliance auditing and/or monitoring experience in the Pharmaceutical or life sciences industry is required
  • Experience working under a government agreement (e.g. CIA, DPA, Consent Decree) is required
  • Demonstrates strong interpersonal skills and ability to influence at all levels of the organization
  • Excellent communication and organization skills
  • Excellent project management skills to oversee and drive project execution
  • Ability to manage multiple projects concurrently and collaborate across several functional areas
  • The ability to think objectively and use sound reasoning principles
  • Ability to manage multiple projects to completion meeting internal and external deliverables with high degree of accuracy
  • Excellent communication skills (written and verbal), strong report writing skills and organization skills are required
  • Uncompromising ethics and high standard of personal integrity
  • Ability to work proactively and independently with minimal supervision
  • Proficiency in Microsoft Office Suite
  • Supervisory experience preferred

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

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
 Apply here
Posted 10/27/2018

MANAGER, OFFICE OF BUSINESS INTEGRITY AND ETHICS - Vertex Pharmaceuticals
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 to the Head of Global Operations, the Manager/Senior Manager will be responsible for supporting all aspects of the Global Operations Team, including policy creation and drafting, training and communications, transactional and live monitoring, auditing, and enhancing its Global Anti-Bribery/Anti-Corruption Program. The Manager/Senior Manager must have knowledge of the Anti-Kickback Statute and the Foreign Corrupt Practices Act and should have experience working with or for biotechnology/pharmaceutical companies on these issues. The Manager/Senior Manager will work collaboratively and strategically with colleagues in the Office of Business Integrity & Ethics, 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 Vertex's growing Department.

Responsibilities:

  • Evaluate and enhance Company policies, SOPs, guidelines, and associated internal communication and training plans related to key areas of vulnerability relevant to global pharmaceutical companies.
  • Prepare and deliver compliance-related training, including new hire training, annual Code of Conduct training, policy-related training and scenario-based training on ethical decision-making.
  • 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.
  • Monitor field Commercial, Medical Affairs and Managed Markets transactions, activities, and processes and perform transactional monitoring to assess compliance with Company policies and procedures.
  • Manage and prioritize multiple complex projects; collaborating with multi-functional subject matter experts and stakeholders, as required.
  • Prepare and provide reports, presentations, materials, guidelines, and documents for employees, senior management and the Board of Directors.
  • Design new and enhance existing processes, controls, and systems, including the fair market value process, to effectively address and mitigate key risks.
  • Partner with OBIE and Legal colleagues across regions to address issues and identify opportunities for collaboration, alignment, process improvement and best practice sharing.
  • Draft company-wide communications related to Program initiatives or enhancements
  • Develop and demonstrate knowledge and competency to serve as a compliance and ethics subject matter expert.

#LI-RS1

Minimum Qualifications

  • Candidates should have strong academic credentials and at least 3-4 years of experience in a law firm or as a compliance professional in a global life sciences company.
  • Knowledge of laws and regulations relating to prescription pharmaceuticals.
  • Outstanding written communication skills, with an ability to cogently and succinctly communicate complicated legal and compliance principles in a straightforward, understandable manner.
  • Strong ability to communicate with all levels of management and employees, both in writing and verbally.
  • Possess sound, practical judgment in the interpretation and application of relevant laws, regulations, industry standards and Company policies.
  • Self-motivated and able to work with minimal supervision; able to exercise sound judgment in resolving matters of moderate complexity or escalating matters appropriately.
  • Strong analytical skills (including skills analyzing large quantities of data) and critical thinking as well as demonstrated attention to detail.
  • Ability to handle multiple tasks in a fast-paced environment is essential.
  • Strong interpersonal skills, with ability to forge strong relationships with all levels of the organization, under challenging conditions and effective influencing skills with the ability to drive change as it relates to implementing remedial actions.
  • Excellent project management skills with the ability to organize and manage multiple priorities while meeting deadlines.
  • Confidence and professionalism to handle difficult conversations and discretion on sensitive matters.
  • Demonstrated strong commitment to compliance, ethics and accountability.

Preferred Qualifications

  • International experience.
  • Extensive experience with Microsoft PowerPoint and Excel.
  • Fluency in additional language(s).

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.

Req ID
10914BR

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Posted 10/24/2018

HEALTH CARE COMPLIANCE SENIOR MANAGER - (180000F5) - Actelion Pharmaceuticals Ltd.


About the Company
Actelion Pharmaceuticals Ltd., a Janssen Pharmaceutical Company of Johnson & Johnson, is recruiting for Health Care Compliance Senior Manager.

As part of the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it.

Actelion is a leader in the field of pulmonary arterial hypertension (PAH). Our portfolio of PAH treatments covers the spectrum of disease, from WHO Functional Class (FC) II through to FC IV, with oral, inhaled and intravenous medications.

Job Summary
The Health Care Compliance Manager is responsible for collaborating with business partners and providing strategic guidance on commercial programs, initiatives and processes that have health care compliance-related implications. The Health Care Compliance Manger, in coordination with the Director, Health Care Compliance will provide direction and oversight of the Health Care Compliance (HCC) Program for multiple products within an Operating Company and ensure the business integrates health care compliance and corporate integrity principles into strategic plans and tactics.

Job Responsibilities
The Health Care Compliance Manager is responsible for the review of commercial strategies and material, such as field sales aids, informational brochures, professional and consumer marketing materials, public-relations materials, press releases, sales training documents, internal communications, brand business plans, field incentive compensation programs, and field call plans to facilitate compliant growth and ensure that materials comply with company policies and procedures including the Healthcare Regulatory Guidance Documents for Promotional & Marketing Practices, industry standards and applicable state and federal laws

Perform risk assessment mitigation process and advising Business

Management of potential compliance risk areas and recommended action plans.

Anticipate potential problems and proactively take appropriate steps.

Oversee the creation of appropriate tracking mechanisms based on problem identification; provide clarity around the ambiguities of the evolving HCC environment.

Assess compliance-related educational needs formulate and facilitate compliance training programs for all employees, agents, affiliated providers, or others working with the Business.

  • Ensure accountability for compliance through risk assessment, problem identification, oversight & monitoring, investigation and follow-ups. In consultation with the Health Care Compliance Officer, Human Resources, and the Law Department, responsible for ensuring there is a mechanism in place for appropriately disciplining instances of non-compliance and ensuring consistency in the application of disciplinary action.

The Health Care Compliance Officer, in conjunction with the Health Care Compliance Officer will be accountable for communicating company healthcare compliance standards and information updates on new laws and guidance to committee members, key business partners and agencies.

Candidate Qualifications & Requirements
This job requires a combination of analytical, organizational and interpersonal skills. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

REQUIRED:

  • BA/BS with eight years relevant experience in the healthcare industry with knowledge of Health Care Compliance programs and policies, Federal health care programs, and FDA requirements ; equivalent combination of advanced degree and less experience may be considered.

PREFERRED:

  • Strong track record of working in a collaborative environment with demonstrated evidence of maintaining relationships and partnerships with peers and business partners
  • Broad business experience and a proven ability to influence business decisions and business partners
  • Demonstrated ability to analyze data and trends, and communicate complex information to all levels of the company required
  • Experience working with the governmental regulatory bodies and managing HCC company policies
  • Engaging and personable demeanor; be self-directed, detail-oriented and motivated; demonstrate a high level of accountability, leadership, and decisiveness and the ability to prioritize, and execute on multiple and frequently changing priorities
  • This position is located in San Francisco, CAL and requires travel up to approximately 20% of the time

If you are interested in making an impact by working in a culture of innovation, trust and teamwork, we welcome your application.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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Primary Location: US-CA-South San Francisco
Job: Legal & Intellectual Property & Compliance
Schedule: Full-time
Job Type: Standard
Job Posting: Oct 9, 2018

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Posted 10/17/2018