The Pharmaceutical Compliance Forum

Employment

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EMPLOYMENT OPPORTUNITIES

 

HEALTHCARE COMPLIANCE OFFICE (HCO) SR. COMPLIANCE MANAGER - Genentech, Inc.

Develops and maintains an in-depth understanding of Genentech's business, organizational structure, reporting relationships, core business practices, policies & procedures, as these relate to healthcare compliance and ethics. Co-develops and executes a compliance training curriculum across all business and functional areas in close collaboration with internal and external stakeholders/partners, to ensure that high quality training materials and programs are developed and delivered.


RESPONSIBILITIES:

Training Development & Delivery

  • Assists to execute HCO Training Strategy and oversee and deliver training curriculum
  • Works with HCO team to pull through policy changes to develop relevant training as required
  • Serves as a training expert to HCO by identifying current gaps in training content and strategy, creating implementation plans and managing stakeholders.
  • Owns, develops and delivers complex training across several functional or business areas that drive role effectiveness for the targeted audience.
  • Ensures that all trainings designed and delivered are fully aligned with Genentech's standards, operational objectives and compliance culture.
  • Evaluates the effectiveness of the training programs, delivery methods, content and training materials.
  • Delivers live trainings in group settings
  • Partners with functional and business areas to assist with or create customized compliance training
  • Where applicable, manages outside vendors to ensure on-time, on-target and within-budget deliverables.

Policy Development

  • Keeps current in the area of healthcare compliance and ethics.
  • Proactively identifies and addresses compliance issues and recommends new or amended healthcare and related compliance and ethics policy statements to HCO and cross-functional leadership, partners and other stakeholders including specifying actual or potential implications to existing business operations, procedures and practices
  • Participates, with limited direction, in complex cross-functional internal teams reviewing business processes that affect Genentech compliance, ethics and related role-based compliance manuals
  • Helps others apply laws and regulations correctly and ensure consistent adherence. Is relied upon for sound compliance guidance and applies a strategic approach to problem-solving
  • Acts as a point-of-contact for questions about healthcare, ethics and related compliance statements. Includes responding to inquiries and providing guidance on compliance and resources to support business operations, team and individual adherence
  • As assigned, assists with other HCO duties and/or projects including but not limited to matters related to operations, privacy, audit and transparency areas.

REQUIREMENTS:

  • Has impeccable ethics. Demonstrates, or has proven abilities to demonstrate, Roche Values & Leadership Commitments
  • Strong verbal and written business communication skills: highly adept at synthesizing and summarizing complex and/or voluminous content into clear, concise and actionable communication or training
  • Strong influencing skills: proven track record and experience building and cultivating relationships with key partners and stakeholders across organizational levels
  • Strong negotiation skills: can effectively drive discussions and decisions toward desired end-results
  • Strong process-orientation: has proven effectiveness in identifying, developing and implementing scalable/sustainable process and other continuous improvements to achieve organizational efficiencies and increase effectiveness
  • Excellent project management skills: can prioritize multiple tasks and goals to ensure timely, on-target and within-budget accomplishments
  • Strong business acumen: understands how the business "works" and demonstrates consistently effective "navigation" across the organization
  • Demonstrates ability to identify appropriate resources. Exercises good judgment in terms of when to leverage internal resources
  • Thinks "outside of the box" for effective training solutions
  • Must demonstrate in-depth knowledge of the bio/pharma industry (compliance, legal, clinical affairs, and product marketing)
  • Must demonstrate in-depth knowledge of the legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma industry (includes anti-kickback statutes, government fraud & abuse, off-label promotion, PhRMA Code, etc.)
  • In-depth knowledge of and experience with instructional design a plus
  • Ability to travel
  • Bachelor's Degree (life sciences, law, public policy, marketing, business, education, finance/accounting or related discipline preferred)
  • Graduate-level Degree preferred (JD, MBA, MEd or related discipline)
  • Healthcare Compliance Certification (before or w/in 6 months of appointment) required
  • 6 or more years of work experience in legal, compliance, policy, auditing, training, communications or related discipline in the bio/pharma industry
  • 4 or more years of previous experience leading large-scale cross-functional project teams or other forums in design, development and implementation of training, policies, programs or projects with significant organizational impact
 Apply here
Posted 4/18/2019

CORPORATE COMPLIANCE BUSINESS PARTNER, REPORTING AND LICENSING - kaléo

Summary of Position:
The Corporate Compliance & Business Ethics Department is seeking an experienced compliance professional to join its team to serve as the primary point of contact for transparency reporting. In this role, the Compliance Business Partner will have significant responsibility for the company's federal and state aggregate spend reporting, as well as managing various licensing requirements across the organization. The Compliance Business Partner will also work collaboratively with other Compliance colleagues in developing and maintaining workflows, databases, and reports in support of the Compliance Department's overall initiatives. This position is based at the company's headquarters in Richmond, VA.


Essential Functions/Principal Duties and Responsibilities

  • Responsible for the collection, loading, aggregation, and filing of spend data for reporting under federal and state aggregate spend laws and regulations
  • Responsible for ensuring compliance with other transparency laws and regulations
  • Manage collection and review of spend activity from internal and external sources
  • Collaborate with and serve as the primary point of contact for internal and external business partners in connection with the company's aggregate spend program
  • Research and resolve inquiries and disputes received from covered recipients related to reporting matters
  • Develop policies and guidelines to enhance the company's aggregate spend reporting, including procedures and tools to capture all applicable data for reporting from relevant stakeholders
  • Perform analysis of aggregate spend data to identify outliers, trends, patterns, risk indicators, or other compliance-related metrics
  • Responsible for the maintenance of pharmaceutical manufacturer licenses
  • Create and continuously improve compliance-related workflows and processes using technology solutions and systems
  • Develop and maintain expertise and knowledge of industry compliance issues and enforcement activities, applicable laws and regulations, and industry standards (including issues relating to the Anti-Kickback statute, promotional sales issues, PhRMA Code, and federal and state transparency reporting)
  • Identify gaps and make observations and recommendations for continuous improvements to policies, procedures, and training based on data analysis and key industry compliance learnings
  • Engage with appropriate business partners to continuously improve compliance function
  • Communicate (orally and in writing) results of work to business partners and Compliance colleagues
  • Support the Compliance Department on other projects and initiatives as requested and needed

Educational, Certification or Experience Requirements

  • Bachelor's degree
  • A minimum of 5 years of legal or compliance experience in the pharmaceutical industry
  • Previous responsibility for managing transparency reporting for a pharmaceutical manufacturer or other covered entity

Competency Requirements

  • Familiarity with legal and compliance issues relating to pharmaceutical business operations and activities (e.g., OIG, PhRMA, FDA, FCPA, Anti-Kickback Statute, False Claims Act, pharmaceutical promotion issues, and transparency)
  • Critical thinker with the ability to take initiative, make sound judgments and recommendations, and follow-through
  • Excellent communication and presentation skills
  • Strong interpersonal and relationship-building skills
  • Ability to deliver results and thrive in a challenging, fast paced, dynamic environment
  • Ability to work independently and as a part of diverse teams
  • Strong time management and administrative skills
  • High level of comfort with technology solutions and systems, including workflow management, process improvement, and data analytics tools
  • Proficiency with aggregate spend tools
  • Detail-oriented and skilled in data analytics
  • High level of integrity, dependability, and accountability

Other Preferred Experience or Qualifications

  • Master's or other advanced degree
  • Compliance or audit certification (e.g., CHC, CCEP, CPA, or CFE)
 Apply here
Posted 4/16/2019

COMPLIANCE MONITOR - kaléo

Summary of Position:
Together with the Corporate Compliance & Business Ethics Department, the Compliance Monitor will be responsible for ensuring kaléo maintains an effective compliance program. The Monitor will have significant responsibility for the department's transactional monitoring and auditing program across various business units and activities. The Monitor will also support other compliance monitoring and auditing activities, as well as assist in ensuring risk assessment and mitigation strategies are effectively implemented. This position is based at the company's headquarters in Richmond, VA.


Essential Functions/ Principal Duties and Responsibilities

  • Develop and execute a transactional monitoring and auditing plan to evaluate the company's adherence to policies, procedures, training, and applicable laws
  • Collect and analyze data across business activities to identify outliers, trends, patterns, risk indicators, or other compliance-related metrics
  • Support risk assessments and analyze relevant data to assess compliance risks and recommend mitigating actions
  • Develop and maintain tools, dashboards, reports, and databases related to transactional monitoring and auditing activities
  • Develop and maintain expertise and knowledge of industry compliance issues and enforcement activities, applicable laws and regulations, and industry standards (including issues relating to the Anti-Kickback statute, promotional sales issues, PhRMA Code, and federal and state transparency reporting)
  • Identify gaps and make observations and recommendations for continuous improvements to policies, procedures, and training based on monitoring findings and key industry compliance learnings
  • Engage with appropriate business partners to continuously improve compliance function
  • Communicate (orally and in writing) monitoring results to business partners and Compliance colleagues
  • Support the Compliance Department on other projects and initiatives as requested and needed

Educational, Certification or Experience Requirements

  • Bachelor's degree
  • A minimum of 3-5 years of legal, compliance, or auditing experience in the pharmaceutical or other regulated industry
  • Previous responsibility for monitoring activities within a compliance function

Competency Requirements

  • Familiarity with legal and compliance issues relating to pharmaceutical business operations and activities (e.g., OIG, PhRMA, FDA, FCPA, Anti-Kickback Statute, False Claims Act, pharmaceutical promotion issues, and transparency)
  • Critical thinker, who is self-motivated with the ability to take initiative, make sound judgments and recommendations, and monitor follow-through
  • Excellent communication and presentation skills
  • Strong interpersonal and relationship-building skills
  • Ability to deliver results and thrive in a challenging, fast paced, dynamic environment
  • Ability to work independently and as a part of diverse teams
  • Strong time management and administrative skills
  • High level of comfort with technology solutions and systems, including workflow management, process improvement, and data analytics tools
  • Detail-oriented and skilled in data analytics
  • High level of integrity, dependability, and accountability
  • Ability to travel (up to 25% of time)

Other Preferred Experience or Qualifications

  • Master's or other advanced degree
  • Compliance or audit certification (e.g., CHC, CCEP, CPA, or CFE)
 Apply here
Posted 4/16/2019

SENIOR DIRECTOR, US LEAD, ETHICS & COMPLIANCE - Alnylam Pharmaceuticals
Based in Cambridge, MA

Alnylam was founded in 2002 on a revolutionary vision and bold mission that remain firmly in place today. We are leading the translation of RNAi as a new class of medicines with a core focus on RNAi therapeutics. Our research focuses on genetically defined targets for the treatment of serious, life-threatening diseases with limited treatment options for patients and their caregivers. In January 2015, we announced our "Alnylam 2020" guidance that reflects our expected transition from a late-stage clinical development company to a multi-product commercial-stage company with a sustainable development pipeline. Alnylam is proud to have been recognized as one of The Boston Globe's Top Places to Work in 2015-2018.

Reporting to the VP, Global Head, Ethics and Compliance in Cambridge, MA, and partnering closely with the Regional Lead, US Business and US Regional Medical Affairs, the Senior Director, US Lead, Ethics & Compliance will lead the design, implementation, and enhancement of an effective global ethics and compliance program for Alnylam's US Business. The Senior Director will work closely with other Ethics & Compliance colleagues, and with Legal, Regulatory and other business colleagues to ensure employee adherence to the Company's Code of Conduct and related rules, policies, and procedures.

The Senior Director will be a member of the US Management Team, expected to actively participate and contribute to US Regional Management, and will partner closely with business colleagues across the Company to sustain Alnylam's strong ethical culture. In particular, the Senior Director must


  • Establish a collaborative and proactive partnership with the Legal team and the regional and local management in the US Business and Medical Affairs, and
  • Represent regional needs and requirements within the Global Ethics and Compliance team and make sure that local requirements are appropriately addressed in any Global or Regional policies

Responsibilities

  • Work alongside employees and company leadership to maintain and further develop throughout the organization a strong culture of ethics and compliance, including personal accountability at all levels in the organization, with a spirit of partnership and positive problem solving
  • Advise the Head of the US Business and his Leadership Team, as well as the US Medical Affairs team, regarding Compliance obligations and continue to evolve the US Region's current compliance program and ensure that it is consistent with the values and principles of the organization, fit for purpose and complies with regulatory requirements
  • Develop and implement a tailored regional governance framework including, if appropriate, a US compliance committee for oversight of the regional compliance program
  • Draft and implement appropriate policies, in collaboration with Legal and other Ethics & Compliance colleagues, to ensure compliance with applicable laws, regulations and codes applicable in multiple countries (excluding cGMP, cGCP and other GXP guidelines)
  • Support the implementation and continued adherence to US transparency reporting requirements and assist business leadership in meeting reporting obligations
  • Work with US Regional leadership on the implementation of a robust privacy program and on adherence to US privacy laws
  • Assist in implementation and execution of risk based third party due diligence
  • Execute compliance risk assessments periodically, at least annually, and create and oversee appropriate improvement plans to mitigate risk appropriately, in a tailored and prioritized manner.
  • Prepare and deliver compliance training and education to the US Regional organization to ensure understanding of employee responsibilities and ethics and compliance issues, as well as related policies and procedures
  • Design and execute routine and risk based monitoring and auditing of relevant business activities and related policies and procedures; assist in and oversee the implementation of corrective action plans as necessary; and generate and deliver reports to leadership on monitoring, auditing and risk assessment.
  • Conduct or assist in investigations into reported compliance concerns or any allegations of misconduct, as required
  • Travel required
  • Other responsibilities as may be assigned from time to time in the company's discretion

Education, Experience & Skills

  • Legal degree strongly preferred, other relevant accreditations or degrees considered
  • Minimum of 10 years of ethics, compliance or a mix of compliance and legal experience in an organization subject to global biopharmaceutical, medical device or other relevant healthcare compliance laws and regulations, preferably in rare diseases
  • Demonstrated ability to work cross-functionally and collaboratively with US and ex-US personnel
  • Experience with transparency reporting requirements and systems
  • Knowledge of laws and regulations applicable to global pharmaceutical companies, including among other things, the Foreign Corrupt Practices Act, US fraud and abuse and false claims laws, and PhRMA Code on Interactions with Healthcare Professionals.
  • Must be able to work collaboratively in a team environment with a wide variety of company personnel on a broad range of matters, including physicians, scientists and individuals of different nationalities. People management experience strongly preferred
  • Ability to manage multiple tasks simultaneously, to work independently and manage discrete areas of responsibility with little direct supervision, and to flourish in a fast-paced and high stress environment
  • Able to thrive in a proactive ethical culture in which compliance and business objectives are mutually reinforcing; strong motivation and ability to champion a comprehensive compliance program that is integrated well with the Company's business and culture
  • Excellent organization, communication (verbal and written) with fluency in written and spoken English required, and prioritization skills, including the ability to communicate concisely

Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.

 Apply here
Posted 4/12/2019

ASSOCIATE DIRECTOR/DIRECTOR, US COMPLIANCE BUSINESS PARTNER - Vertex Pharmaceuticals Incorporated
Office of Business Integrity & Ethics
Boston, MA
Full-Time

Overview
Vertex Pharmaceuticals Incorporated is seeking an experienced Compliance professional to join its Office of Business Integrity & Ethics (OBIE). OBIE is responsible for the development, implementation, oversight, and continuous improvement of Vertex's Compliance program. This includes defining standards via policies and procedures, creating and implementing training and communications, conducting auditing and monitoring and other assurance activities, facilitating internal reporting, discretely and professionally conducting compliance-related investigations, and keeping the CEO, the Executive Committee, and the Board of Directors informed on Compliance matters. OBIE serves as the go-to experts for Vertex employees and external stakeholders on issues relating to Vertex's Compliance program and Code of Conduct globally.

Job Description
Reporting to the Deputy Chief Compliance Officer, the US Compliance Business Partner will serve as the primary point of contact for US and Canada business colleagues across all Commercial, Medical, Clinical, Research, Development, and support functions. The US Compliance Business Partner will work closely with our OBIE Operations team and International Compliance Business Partners in further enhancing and implementing our Compliance program and will provide daily support to our business colleagues to ensure effective implementation and understanding. The US Compliance Business Partner must have deep knowledge of pharmaceutical industry regulations and US anti-bribery/anti-corruption laws and extensive experience working for biotechnology/pharmaceutical companies on these issues. Additionally, the US Compliance Business Partner will work collaboratively and strategically with colleagues in OBIE, Legal, and the business to drive a culture of ethics and integrity across Vertex's global organization. If you thrive in a dynamic, fast-paced, hands-on, and team-oriented environment where you can have a big impact on the organization, we'd love to talk to you!


Key Responsibilities

  • Serve as the point of contact for US and Canada business colleagues seeking strategic and tactical guidance on matters of compliance, integrity, and ethics.
  • Provide Compliance oversight, guidance, and direction for US and Canada business colleagues and identify areas where Compliance input and attention is required.
  • Maintain a high level of knowledge of current and emerging laws and regulations and recent enforcement actions and inform and educate business colleagues with tailored communications.
  • Collaborate with cross-functional teams to drive fact- and risk-based decision making.
  • Help to establish standards and implement procedures to ensure the Compliance program is effective and efficient.
  • Develop and maintain strong relationships and collaborate frequently with Legal, Human Resources, Internal Audit, and colleagues in other functional areas both in and outside of the U.S.
  • Support continuous improvement of the Compliance program.

Depending on experience, this position may be at the Director or Associate Director level.

Skills/Abilities/Competencies

  • Consummate team player with excellent judgment and interpersonal skills.
  • Ability to communicate effectively with all levels of management and employees.
  • Demonstrable experience taking ownership of issues and providing timely, actionable guidance.
  • Strong oral and written communication and influencing skills and the ability to proactively and pragmatically collaborate cross-functionally.
  • Strong analytical, organizational, and problem solving skills.
  • Excellent project management skills with the ability to manage multiple priorities simultaneously.
  • Self-starter with demonstrated leadership skills and ability to meet goals given limited supervision; able to exercise sound judgment in balancing risks in ambiguous and complex situations and escalating matters appropriately.
  • Demonstrated superior ability to identify areas for improvement in controls, systems, and processes and implement effective solutions.
  • Ability to work with large amounts of data to analyze information while still seeing the "big picture".
  • Confidence and professionalism to handle difficult conversations and discretion on sensitive matters.

Minimum Qualifications

  • A minimum of 7-10 years working for or in the biotechnology/pharmaceutical industry, with at least 3 years in-house.
  • Knowledge of laws and regulations relating to healthcare fraud and abuse and regulated pharmaceutical products, specifically US anti-bribery/anti-corruption laws and FDA regulations and guidances.
  • Demonstrated strong commitment to compliance, ethics and accountability.
  • Flexibility to work in a fast paced and dynamic work environment with a strong work ethic and positive attitude.
  • Ability to travel approximately 20% of time.
  • Proficiency in MS Office (especially PPT).

Preferred Qualifications

  • Juris Doctorate strongly preferred and a minimum of 4 years working at a large, global law firm.

Company Information
Vertex is a global biotechnology company that aims to discover, develop and commercialize innovative medicines so people with serious diseases can lead better lives. In addition to our clinical development programs focused on cystic fibrosis, Vertex has more than a dozen ongoing research programs aimed at other serious and life-threatening diseases.

Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and commercial offices in the United States, Europe, Canada and Australia. For five years in a row, 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, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

 Apply here
Posted 4/8/2019

SR DIRECTOR, POLICIES AND INVESTIGATIONS, NORTH AMERICA ETHICS AND BUSINESS INTEGRITY - Sanofi Genzyme

Commitment is our Strength. Ready to grow together.

Sanofi US Services, Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

This position drives key elements of the Sanofi NA Ethics & Business Integrity program and reports to the Head of MSOI [Multiple Sclerosis/Oncology/Immunology], NA Ethics & Business Integrity. This position will provide broad scale Compliance support to the business teams and work with all levels of the North America Ethics & Business Integrity (E&BI) Department, members of the Legal Department, and other business functions and outside resources in the implementation of strategic and operational initiatives including aspects of the Company's Corporate Integrity Agreement (CIA). Candidate will design and implement training and knowledge updates pertaining to Federal health care program and FDA requirements and internal policies and procedures to business partners as required. This position will evaluate areas of risk and provide guidance in the design and development of corrective and preventive controls.


JOB SPECIFIC RESPONSIBILITIES:

  • Develop and implement a Compliance policy strategy for all of North America (NA). Create and implement policy content for all Compliance policies for all NA business units. Simplify existing policies and work with global to align where possible. Drive and manage downstream SOP simplification. Align policy content with training strategy.
  • Strategize key risk areas relative to BU, Company, and industry with business leadership to develop key policy initiatives to address business needs and mitigate Company risk
  • Provide day-to-day compliance support for business unit E&BI officers. Define and implement strategic compliance policy plan at the company, business unit level or position type level; identify risks and required actions; analyze data and provide insights for corrective action.
  • Work collaboratively with members of the NA Ethics & Business Integrity Department and Business Leaders as well as other functional areas within the Company to ensure that appropriate actions are taken to satisfy the requirements of the Corporate Integrity Agreement (CIA). Develop proactive strategies and plans to successfully complete the CIA and establish a culture of compliance that mitigates overall corporate risk.
  • Oversee aspects of a Compliance Program, including design, development and policy implementation
  • Work directly with Legal Department and other functional areas to enhance policies and systems controls as needed
  • Conduct and document Internal Investigations relating to potential violations of Company compliance policies/SOPs and/or Federal Health Care fraud and abuse laws
  • Coordinate with other functional areas as necessary to conduct, track and/or document investigations (e.g., HR, Legal, Finance, Security, etc.)
  • Interface with Ethics & Business Integrity colleagues with regard to receipt of potential violations and appropriate follow up documentation, including Helpline administration
  • Assist with the review of potential Reportable Events
  • Identify, recommend, and initiate training activities with other internal functions as it relates to the conduct of Internal Investigations
  • Identify and present appropriate recommendations for enhancements to internal policies and SOPs relating to actual or potential issues identified during the conduct of Internal Investigations
  • As needed, update necessary SOPs, templates, and standards relating to the conduct and documentation of Internal Investigations
  • Manage overall policy simplification budget
  • Assist with compliance-related due diligence in connection with M&A and other integration activities
  • Notify the NA Compliance Officer and other members of senior management of Compliance issues
  • Serve as representative of NA Ethics & Business Integrity Department on select functional committees and project teams
  • Perform other duties as assigned from time to time

BASIC QUALIFICATIONS:

  • 8-10 years of pharmaceutical and/or biotech compliance experience required or 8-10 years of experience in equivalent highly regulated industry
  • 8-10 years of compliance experience or mix of compliance/legal experience
  • Exceptional analytical and operational experience
  • Bachelor's Degree
  • Experience with policy drafting, implementation and simplification
  • Experience in managing and conducting internal investigations
  • Some travel required

PREFERRED QUALIFICATIONS:

  • Strong Compliance background and clear understanding of elements of an effective ethics and compliance program
  • Experience working in a complex, matrix organization
  • Strong project management, training, and planning skills required
  • Excellent oral and written communication skills
  • Experience with risk assessment and risk management
  • Demonstrated ability to be proactive, exercise independent judgment and demonstrated ability to work effectively on cross-functional teams with all levels of management and other company personnel
  • JD strongly preferred

The successful candidate will be required to sign and execute a restricted covenant upon hire.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

 Apply here
Posted 4/8/2019

MANAGER, AUDITING & MONITORING - Boehringer Ingelheim
Location: Ridgefield, CT

The Manager, Auditing and Monitoring, will perform operational duties associated with the Auditing and Monitoring plan, including development of analytical reports, performing analysis of data and providing administrative and logistical support of the Auditing, Monitoring, and Risk Assessment program. This role will interact with members of the Ethics & Compliance Department to help support the development, maintenance and evolution of the Auditing and Monitoring Program and the overall Compliance Program. The Manager will be an Auditing and Monitoring subject matter expert of various internal and external processes and systems associated with his/her assigned responsibilities, and will perform document reviews to ensure compliance with policies, procedures and processes, and will perform operational, analytic and administrative functions to support the Auditing, Monitoring and Risk Assessment function. Limited travel (up to 10%) may be anticipated.

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:

  • Auditing and Monitoring:
  • Assist with managing progress and outcomes of monitoring activities.
  • Perform collection of supporting documentation, perform transactional review and ensure accuracy and completeness of entries in the monitoring system.
  • Coordinate the selection of monitoring activities and orchestrate the logistics of the auditing/monitoring activities.
  • Report Auditing/Monitoring findings into the system of record.
  • System and process expertise:
  • Serve as an Auditing and Monitoring subject matter expert; for the systems, processes and procedures associated with assigned monitoring and auditing responsibilities and beyond when feasible, including relationship with process and system owners.
  • Analytics and Systems:
  • Provide actionable data/reports that support the risk-based Auditing and Monitoring plan; monitoring activities, identifies areas of potential risk, future areas to monitor, and metrics for service level goals.
  • Assist with maintaining and enhancing the current monitoring system to accommodate various types in monitoring.
  • System and Process improvements:
  • Assist with collaborating with internal Ethics & Compliance team members and relevant business stakeholders to identify areas of process and system improvements to create efficiencies, and develop documentation of monitoring processes.

Requirements:

  • Bachelor's degree from an accredited institution or four (4) years of relevant work experience in addition to required minimum experience
  • Minimum of three to five (3-5) years' of operational and analytical experience, with a strong preference in the Pharmaceutical compliance environment.
  • Ability to work independently and deliver results with minimal supervision
  • Demonstrated ability to apply critical thinking with the ability to focus on both the details and the big picture
  • Ability to work collaboratively with internal and external customers
  • Adapts to changing conditions and drives accountability and results
  • Demonstrated ability to manage and communicate confidential information appropriately
  • Possess strong verbal and written communication skills
  • Prior experience with data visualization and analytics software such as Spotfire or Tableau,and high level of experience with spreadsheets
  • Experience in extracting and reviewing documentation from various systems; review for compliance with policies and procedures
  • Experience in maintaining accurate records in systems; accurate data entry, and ensure supporting documentation is complete
  • Ability to identify and implement system and process improvements
  • Experience with use of analytical tools for data analysis; development and maintenance of reports
  • Experience in analyzing and synthesizing data; ability to identify trends, gaps, opportunities
  • Strong communication skills verbal and written; communicating with various internal customers and third parties
  • Knowledge of US pharmaceutical industry regulatory environment, healthcare and applicable laws and codes, business practices, application of BI Policies & Procedures, etc.

Eligibility Requirements:

  • Must be legally authorized to work in the United States without restriction.
  • Must be willing to take a drug test and post-offer physical (if required)
  • Must be 18 years of age or older

Who We Are:
At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.

Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.

Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

 Apply here
Posted 3/26/2019

ASSOCIATE DIRECTOR, AUDITING & MONITORING - Boehringer Ingelheim
Location: Ridgefield, CT

The Associate Director, Auditing & Monitoring, supports the region-wide, risk-based Auditing & Monitoring program, including ownership for portions of the design and implementation of the Auditing and Monitoring Program for BI's U.S. pharmaceutical, bio-similar and animal health businesses. Under the oversight of the Director, Auditing, Monitoring and Risk-Assessment, he or she will have accountability to lead and direct scheduled and for-cause audits, functional reviews and individual assessments of company controls, operating procedures and Compliance consistent with established operating policies and procedures and applicable government regulations. The AD, Auditing & Monitoring will be responsible for day-to-day oversight and accountability of broad elements of the Auditing/Monitoring Program. He or she may also supervise other Auditors/Monitors, and will perform auditing and monitoring activities in the field, with a specific expertise and focus on Field-Based Medicine, Commercial-Medicine interface and Medical monitoring, and other emerging risk topics. 35% travel is anticipated for this role.

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:

  • Responsible to help implement and evolve BI's Auditing & Monitoring Program throughout the United States; assess and incorporate new and emergent risks areas
  • Develop healthcare compliance audit plans to evaluate adherence to company policies, laws, and guidance
  • Develop the Monitoring Program, including healthcare compliance monitoring plans and other areas in partnership with Compliance Business Partners, to evaluate adherence to company policies, laws, and guidance (e.g., field rides, data reviews, patient interactions, etc.)
  • Perform Auditing & Monitoring: Accountable for day-to-day execution of the Auditing/Monitoring program, including; Perform auditing and monitoring, including in the field.
  • Execute Risk Assessments / Create Mitigation Strategies / Report Progress to Plans: Execute periodic healthcare and/or other compliance risk assessment and draft corrective action plan
  • Analyze relevant company and/or field-based data to assess healthcare compliance risks, and identify risk-mitigation strategies.
  • Oversee assignment and accountability for mitigation of auditing/monitoring findings for Compliance Business Partners.
  • Draft reports and assessments related to risk assessment, monitoring and auditing activities
  • Deliver detailed and meaningful presentations (oral and written) on related monitoring, auditing, and risk assessment activities, and assist with the development of periodic reports to relevant stakeholders and the Compliance Committee.
  • Manage, coach and develop team members that support Auditing and Monitoring program.

Requirements:

  • Bachelor's degree from an accredited institution is required and six to ten (6-10) years' experience in a monitoring program role within a pharmaceutical Compliance (or similar) function.
  • Master's degree preferred
  • Compliance Certification preferred
  • Significant experience leading and managing an auditing/monitoring program in the pharmaceutical experience is necessary
  • Must be able to work independently to resolve issues and demonstrate excellent professional judgment
  • Must be able to lead teams and large projects with minimal supervision
  • Prior experience with data visualization and analytics software such as Spotfire or Tableau. Demonstrated ability to work collaboratively with other Compliance leaders, business personnel and with external partners
  • Flexibility and ability to adapt to changing conditions and drive accountability and results
  • Prior experience leading others in auditing/monitoring activities
  • Prior Pharmaceutical industry experience leading Auditing and Monitoring programs and teams, including leadership and overseeing auditing and monitoring activities
  • Medical expertise, knowledge or background sufficient to meaningfully interact and/or understand the medical discussions with healthcare providers.
  • Robust knowledge of Pharmaceutical and related healthcare compliance laws and regulations, and demonstrated knowledge and experience in conducting risk-based audits and monitoring.
  • Excellent communication skills both written and verbal; developing and presenting communications, recommendations and findings to leadership teams.
  • Excellent problem-solving and analysis skills including use of data analytic tools; ability to see trends and convert information to insights.
  • Excellent interpersonal skills with demonstrated track record and ability to drive results as an effective team member and leader.
  • Strong sense of ethics, responsibility and agility; takes accountability for independent and timely decision-making on issues of potential significant liability
  • Ability to travel (approx. 50%) as required to meet business need.
  • Medical background sufficient to meaningfully understand interactions between medical professionals. Solid and working knowledge of U.S. Healthcare Compliance laws and regulations, regulatory enforcement environment, and industry codes, e.g., fraud and abuse, PhRMA Code, business practices, application of many BI Policies & Procedures, etc.

Eligibility Requirements:

  • Must be legally authorized to work in the United States without restriction.
  • Must be willing to take a drug test and post-offer physical (if required)
  • Must be 18 years of age or older

Who We Are:
At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.

Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.

Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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Posted 3/26/2019

COUNTRY PRIVACY ADVISOR - GSK

As a Country Privacy Advisor you will play a strategic part in the Privacy Centre of Excellence here in GSK. Come and join the team! Together we can serve our GSK colleagues to enable them to help patients and consumers around the globe to do more, feel better and live longer!

The Country Privacy Advisor (CPA) will oversee implementation of a fit for purpose compliance program and internal controls framework for all data protection related matters in accordance with Laws and Regulations in the United States and in accordance with the instructions of the Regional Privacy Officer. The Country Privacy Advisor provides leadership in driving local compliance activities across all Business Units, being the primary contact of local Regulators and building an effective partnership with other CPAs globally. Further, the CPA operationalizes the privacy compliance program and manages daily privacy activities.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

Enterprise Country Compliance:

  1. Drive the deployment of the enterprise-wide privacy compliance program locally in line with all GSK's internal policies, regulations and timelines set by the country laws and regulations in their countries.
  2. Advise local process owners and project teams in applying the 'Privacy by design' principles at the outset of country projects and perform Privacy Impact Assessments (PIAs).
  3. Partner with local ethics and compliance officers to report on progress and gaps to the local Risk Management Compliance Boards (RMCBs) for each legal entity
  4. Supporting the closure of local Corrective and Preventative Actions (CAPAs) coming from PIAs, internal audits, external investigations, Independent Business Monitoring (IBM), regulatory changes
  5. Routinely consults with and provides support requested by the RPO

Regulatory management: the CPA own the relationship with Data Protection Authorities (DPAs)

  1. Respond to Enquiries and Complaints from data subjects or DPAs
  2. Support the Business aligned Privacy Leaders (PLs) or Regional Privacy Officers (RPOs) to notify the Data Privacy Authority of breaches within applicable timeframes

Regional Governance: the CPA are active members of a Regional Network chaired by the RPO

  1. Review the content of GSK Privacy Policy, SOPs, standards and training materials to ensure country-specific content and requirements are addressed and report back to the RPO
  2. Create and share best practice materials to accelerate the adaptation of privacy culture within the United States and globally

Why you?
Basic Qualifications:

  • CIPP US or equivalent certification in a privacy, compliance or security area (e.g. CISSP, CISA Currently a Data Protection Officer / Data Privacy Officer
  • Experience in designing controls and successfully managing Risks, Data protection Compliance while demonstrating knowledge of business operations, security and supporting information systems.
  • Demonstrable experience in interacting with regulators
  • Ability to work effectively and sensitively in a highly matrixed organization
  • Ability to provide strategic advice as well as operational solutions.
  • High level of personal integrity, and the ability to professionally handle highly confidential matters and exude the appropriate level of judgment and maturity.
  • Strong problem solving skills that are pragmatic, which demonstrates a strong understanding of business processes and information systems.
  • Excellent written and verbal communication skills, ability to communicate Legal and risk-related concepts to technical and non-technical audiences

Preferred Qualifications: If you have the following characteristics, it would be a plus:

  • Experience within the pharmaceutical or healthcare industry
  • An excellent understanding of privacy regulations and their application to pharmaceutical business and the consequences of non-compliance
  • A practical experience of working in within a service-oriented organization with a clear understanding of who internal customers are and what constitutes tangible, successful deliverables in alignment with an ethics and compliance mindset.
  • Demonstrated confidence in challenging mind-sets, influencing senior business leaders and imposing an unwelcomed compliance decision when required.
  • Connected with peers in the industry to allow sharing of best practices

Why GSK?
Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

  • Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being.
  • Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

 Apply here
Posted 3/25/2019

COMPLIANCE MANAGER, HCO AUDITING - Genentech
LOCATION: South San Francisco, CA


The Healthcare Compliance Office (HCO) offers coordination and oversight for all healthcare compliance matters at Genentech and is responsible for the following key areas: Privacy, Compliance Policy Development, Compliance and Ethics Training & Communications; Auditing, Monitoring, and Investigations. As part of its mission to better serve the organization, all members of the HCO team are expected to develop both their depth and breadth of their expertise in one or more of these areas.

RESPONSIBILITIES:

  • The Healthcare Compliance Office (HCO) Compliance Manager Auditing position leads compliance audits across Genentech.
  • This individual is responsible for conducting complex, in-depth healthcare compliance audits and facilitating corrective action plans within areas of the Genentech organization. This individual designs and effectively executes HCO audits by working closely with other members of the HCO Auditing team or by leading a team comprised of consultants and legal counsel.
    • Develops and maintains an in-depth understanding of Genentech's business, organizational structure, reporting relationships, core business practices, policies & procedures, as these relate to healthcare compliance and ethics;
    • Effectively integrates compliance risk/context, business knowledge, and understanding of database reporting capabilities to develop audit strategies and audit plans;
    • Executes routine and ad hoc healthcare compliance audits of functional processes across Genentech to ensure adherence to healthcare compliance and ethics policies, guidelines, and SOPs;
    • Collects, examines, and analyzes records, policies, operating practices, documentation, and transactions;
    • Performs interviews and walkthroughs with cross-functional stakeholders;
    • Summarizes and communicates audit progress and findings to various levels of management, both live and in written materials;
    • Collaborates with other HCO team members, Legal and cross-functional stakeholders in Commercial, Product Development, Medical Affairs, etc. on audit findings;
    • Draft audit findings and presents audit reports to various levels of management;
    • Designs, delivers, and oversees effective corrective action plans and/or risk mitigation in partnership with cross-functional stakeholders; tracks to ensure that corrective action plans are completed on a timely basis;
    • Develops relationships with Genentech personnel across functions and teams and provides coaching and compliance guidance as needed.
  • As applicable, manages outside consultants and legal counsel to ensure on-time, on-target and within-budget deliverables.
  • As assigned, assists with other HCO duties and/or projects related to areas such as operations, privacy, investigations, policy, and transparency.

CORE COMPETENCIES:

  • Requires limited direction to complete standard work.
  • Excellent project management skills: can prioritize multiple tasks and goals to ensure timely, on target and within-budget accomplishment of such.
  • Proven track record of effective decision-making: makes good business decisions and consistently exercises sound judgment. Applies sound judgment around escalation of issues.
  • Strong verbal and written business communication skills: highly adept at synthesizing and summarizing complex and/or voluminous content into clear, concise and actionable communications.
  • Strong process-orientation: has proven effectiveness in identifying, developing and implementing scalable/sustainable process and other continuous improvements to achieve organizational efficiencies and increase effectiveness.
  • Thinks "outside of the box" for solutions. Applies creative problem solving and appropriate business solutions to effectively address compliance risk.
  • Strong influencing skills: proven track record and experience building and cultivating relationships with key partners and stakeholders across organizational levels. Ability to manage conflict and negotiate corrective actions with cross-functional stakeholders.

QUALIFICATIONS:

  • Bachelors Degree (finance/accounting, life sciences, law, public policy, marketing, business, or related discipline preferred).
  • Professional certification preferred (CPA, CIA, CFE, etc.).
  • Graduate-level Degree preferred (JD, MBA, or related discipline).
  • Healthcare Compliance Certification (before or w/in 6 months of appointment)
  • Ability to travel (less than 10%)

EXPERIENCE:

  • 3 or more years of work experience in auditing, compliance, consulting, legal, or investigations (Big 4 accounting firm, consulting firm, or bio/pharma industry related experience preferred).
  • Previous experience in effectively leading program or project management from inception to implementation.
  • Knowledge of the bio/pharma industry preferred (compliance, legal, clinical affairs, and product marketing).
  • Knowledge of the legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma industry preferred (includes anti-kickback statutes, government fraud & abuse, off-label promotion, PhRMA Code, etc.).
  • Experience in other compliance disciplines (privacy, policy, healthcare monitoring, transparency) a plus.

 Apply here
Posted 3/23/2019

DIRECTOR GLOBAL COMPLIANCE RISK MONITORING AND ANALYTICS - Seattle Genetics


Job Description
Reports To: VP and Compliance Officer
Department: Legal Affairs
Location: Bothell, Washington
Last Updated: March 1, 2019

Seattle Genetics is an emerging global multi-product biotechnology company that develops and commercializes innovative antibody-based therapies for the treatment of cancer. The company's industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. In addition to one marketed product, we are advancing a strong product pipeline of novel therapies for solid tumors and blood related cancers designed to address significant unmet medical needs and improve treatment outcomes for patients. More information about Seattle Genetics can be found at www.seattlegenetics.com.

Position Summary:
The Director/Senior Director of Global Compliance Risk, Monitoring & Analytics will report to the VP and Compliance Officer and be responsible for strategic leadership and regular evolution of Seagen's healthcare compliance Risk Assessment & Management Plan (RAMP) process and related compliance monitoring program.

This includes managing internal and external resources in the performance of systems and process audits of compliance with U.S. federal and state laws and regulations related to the promotion, sale and marketing of Seagen therapies, in addition to potential monitoring and auditing activities based on requirements outside the United States.

In addition, this role requires analyzing and interpreting data to facilitate the communication of key insights and findings to key stakeholders and business partners. This role has the additional responsibility of leading the development and implementation of the periodic evaluation of the effectiveness of Seagen's overall Compliance Program.

Primary Accountabilities:

  • Leading the administration and regular enhancement of Seagen's Risk Assessment and Management Plan (RAMP) policies and processes
  • Leading the administration and regular enhancement of Seagen's risk-based monitoring program policy and processes designed to help ensure compliance with healthcare laws, regulations and guidance (such as the Anti-Kickback Statute, False Claims Act, OIG Guidance for Pharmaceutical Manufacturers, PhRMA Code & FDCA), and detect and prevent potential fraud and non-compliance, and any other related Seagen requirements
  • Driving the process of assessing, monitoring and mitigating compliance risks across commercial and non-commercial functions by developing, enhancing and executing the compliance audit and monitoring programs, including the performance of field rides, with potential coordination and management of external resources as warranted and in collaboration with other assurance functions (e.g., Internal Audit); This will require personal engagement in the conduct of such activities, as well as management of the team's performance implementation of these activities
  • Performing detailed transactional audits, potentially including: engagement of assorted third-parties; research and educational grant funding; and other non-promotional practices
  • Design and deliver meaningful, accurate and effective presentations to senior management and ensure follow-up on any areas that require corrective action
  • Oversee the management and maintenance of various systems and tools related to RAMP, monitoring and analytics, and recommend enhancements to the same
  • Identify, develop and help implement enhanced monitoring controls as warranted
  • Be able to handle all matters as confidential, demonstrate an ability to effectively and continually prioritize, and identify new issues requiring attention in a risk-based manner and help drive resolution within and beyond scope of responsibility
  • Identify matters that require elevation to senior management on mitigation of risk and improving the effectiveness of the Compliance Program.
  • Provides coaching, direction, and feedback to direct reports to support their growth and achieve business results
  • Travel required with this position (up to 50%).
  • Role includes management and budgetary responsibilities.

Qualifications / Education:

  • 9-14 years of experience with PhD or JD., 12-17 years of experience with a Master's degree, and 14-19 years of experience with a Bachelor's degree
  • Experience in compliance risk management and monitoring/auditing experience with a global or regional life sciences company, accounting firm or healthcare consulting firm with emphasis in life sciences is required.
  • Experience in Healthcare Compliance, particularly in pharma/biotech strongly preferred.
  • Experience developing and/or implementing compliance program analytics strongly preferred.
  • Effective team management skills across the full continuum of recruitment, coaching, performance management and employee development, while developing a high performing and collaborative team
  • Proven ability to build and lead the execution and management of compliance monitoring programs, and to execute audit plans and conduct compliance systems review audits with minimal supervision
  • Experience with data analytics and data mining skills
  • Strong project management skills; with the ability to drive execution by team members and others
  • High level problem solving, judgment, detail-oriented and confidentiality; comfortable with ambiguity and can adapt style and tactics based on situation
  • 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
  • Ability to effectively prepare and present analytical written and oral communications appropriate for multiple audiences and levels within the organization including senior-level executives
  • Knowledge of and experience with laws, regulations and industry guidance that affect the pharmaceutical industry including OIG and PhRMA guidelines, healthcare standard operating procedures, Sunshine provisions of the Affordable Care Act, Food, Drug & Cosmetics Act and supporting regulations, OPDP requirements and state price reporting statutes

Competencies:

  • Manages Ambiguity
  • Courage
  • Manages complexity
  • Decision quality
  • Business insight
  • Communicates Effectively
  • Manages conflict
  • Drives results
  • Strategic mindset
  • Plans and aligns

 Apply here
Posted 3/21/2019

DIRECTOR, ETHICS & COMPLIANCE - Purdue Pharma L.P.
Department: Ethics & Compliance
Location: Stamford
Grade: MGT6
Position Reports to: VP, Ethics & Compliance
FLSA Status: Exempt


Job Summary
Serve as a leader in the ethics and compliance program for Purdue and its subsidiaries, with primary responsibility for auditing and monitoring, continuously improving compliance reporting systems, and, directing the Company's Enterprise Risk Management (ERM) process. Responsible for leadership of ethics and compliance activities within portions of Commercial, Medical, Technical Operations, and R&D business areas, providing advice to allow individuals in these areas to operate within full compliance of laws, regulations, and guidance. Provide strategic direction and partnership to the business, advising on risk and assessing initiatives for full compliance and integrity.

Primary Responsibilities

  • Serve as a business partner, providing ethics and compliance guidance to various business units including but not limited to Commercial, Medical, Technical Operations, and R&D.
  • Direct and improve the Company's Enterprise Risk Management function.
  • Develop and execute an annual Monitoring Plan and provide input on/conduct related audits. Conduct and/or collaborate on audits and assessments and establish and oversee monitoring systems within the ambit of the Purdue ethics and compliance program. Analyze and present findings of same.
  • Direct Purdue's Fair Market Value (FMV) process.
  • Develop Standard Operating Procedures (SOPs) and Working Practices Documents (WPDs), as needed, both for Ethics & Compliance Department and other functions, and assist in implementation of training programs related to same. Monitor internal compliance with relevant SOPs and/or WPDs.
  • Serve as subject matter expert on privacy matters.
  • Conduct investigations, as needed.
  • Conduct compliance-related diligence activities for product/company development activity, as needed.
  • Participate in industry ethics and compliance and other leadership roles for benchmarking and professional development.
  • Oversee staff participating in above-outlined functions.
  • Stay current on ethics and compliance issues/hot topics, as well as industry trends, best practices, federal and state guidances, etc.

Education and Experience Requirements

  • Bachelor's Degree required. Advanced degree a plus.
  • At least 10 years relevant compliance, legal, or other relevant experience, with a minimum of four years of pharmaceutical or healthcare legal or compliance experience required; relevant advanced degrees are desirable and may count toward experience.
  • Demonstrated leadership skills, together with experience supervising others, as well as interacting with all levels of management.

Necessary Knowledge, Skills, and Abilities

  • Able to gain the confidence and trust of others through integrity, honesty and authenticity
  • Builds partnerships and works collaboratively with diverse teams to meet shared objectives
  • Excellent written and verbal communication skills; ability to convey information effectively to a wide range of audiences; comfortable with public speaking and presentations
  • Strong leadership and interpersonal skills; ability to collaborate with senior management, leadership, employees, government officials and external audiences to develop and maintain good working relationships
  • Consistently achieves results even under difficult circumstances

Supervisory Responsibilities (if Applicable)
N/A
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Posted 3/21/2019

COMPLIANCE COUNSEL - Neurocrine Biosciences


WHO WE ARE: At Neurocrine Biosciences - voted one of San Diego's top places to work in 2018 - we pride ourselves on having a strong, distinctive and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve patient suffering and enhance lives.

WHAT WE DO: Neurocrine Biosciences is a biopharmaceutical company focused on developing treatments for neurological and endocrine related disorders.

ABOUT THE ROLE: The Compliance Counsel reports to the Chief Compliance Officer and will be responsible for assisting in the execution and continuous improvement of the Neurocrine Compliance and Ethics program to ensure compliance with all applicable laws and regulations.

YOUR CONTRIBUTIONS (include, but are not limited to):

  • Provide sound compliance guidance to employees of Neurocrine, consistent with applicable laws, regulations and Neurocrine policies
  • Conduct and manage compliance investigations regarding allegations of potential violations of law or company policy and/or ethical standards, prepare reports on the results of the investigations, and assist with the determination and implementation of corrective actions
  • Conduct monitoring and auditing to ensure compliance with applicable laws, regulations and Neurocrine policies, including field rides, speaker programs and advisory boards
  • Analyze monitoring and auditing results to recommend improvements in compliance or business operations
  • Assess compliance training needs, develop and deliver effective and creative training, including written materials, computer-based training and live presentations
  • Provide compliance input and expertise into business decisions, including development of solutions-orientated risk mitigation strategies
  • Perform other duties as assigned/requested

REQUIREMENTS:

  • BA/BS and JD required 3+ years of experience in the biotech/pharmaceutical or medical device industry
  • In depth understanding of the Anti-Kickback Statute, the False Claims Act, Federal Food, Drug, Cosmetic Act; PhRMA Code; OIG Seven Elements; HIPAA; and federal and state transparency and disclosure laws
  • Strong knowledge of industry compliance best practices, regulatory landscape, and pharmaceutical compliance training and monitoring programs
  • Excellent verbal and written communications skills; must be an effective communicator with strong interpersonal skills
  • Ability to 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

WORKING CONDITIONS:
Office based in San Diego, CA, approximately 30% domestic travel

To apply, visit the Neurocrine Careers website at https://www.neurocrine.com/careers/overview

Neurocrine Biosciences is an EEO/AA/Disability/Vets Employer
 Apply here
Posted 3/12/2019

HEALTH CARE COMPLIANCE SENIOR MANAGER - Actelion Pharmaceuticals Ltd.
Job Number: 7028190215


Description:
Actelion Pharmaceuticals Ltd., a Janssen Pharmaceutical Company of Johnson & Johnson, is recruiting for Health Care Compliance Senior Manager to be located in South San Francisco, CA.

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.

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.

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.

Qualifications:

  • A minimum of a Bachelors degree is required.
  • A minimum of 8 years relevant experience in the healthcare industry with knowledge of Health Care Compliance programs and policies, Federal health care programs, and FDA requirements is required.
  • Strong track record of working in a collaborative environment with demonstrated evidence of maintaining relationships and partnerships with peers and business partners is preferred.
  • Broad business experience and a proven ability to influence business decisions and business partners is preferred.
  • Demonstrated ability to analyze data and trends and communicate complex information to all levels of the company required is required.
  • Experience working with the governmental regulatory bodies and managing HCC company policies is preferred.
  • This position is located in San Francisco, CAL and requires travel up to approximately 20% of the time.

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. This site is governed solely by applicable U.S. laws and governmental regulations. Please see our Privacy Policy. Use of this site constitutes your consent to application of such laws and regulations and to our Privacy Policy. Your use of the information on this site is subject to the terms of our Legal Notice. You should view the News section and the most recent SEC Filings in the Investor section in order to receive the most current information made available by Johnson & Johnson Services, Inc. Contact Us with any questions or search this site for more information.

Primary Location:
North America-United States-California-San Francisco

Organization:
Janssen Pharmaceuticals, Inc (6062)

Job Function:
Health Care Compliance

PI108042362
 Apply here
Posted 2/27/2019

SENIOR MANAGER - GOVERNMENT ACCOUNTABILITY - Novo Nordisk


About the Department
At Novo Nordisk, we're committed to building the best Ethics and Compliance (E&C) team in the pharmaceutical industry. Operating at the highest ethical standards and ensuring adherence to corporate and legal regulations, the E&C 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, E&C keeps us accountable every step of the way as we develop life-changing therapies and bring them to market. At Novo Nordisk, you will be part of a company respected equally for its financial results and its business ethics. Are you ready to make a difference?

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

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

Essential Functions

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

Physical Requirements
0-10% overnight travel required.

Qualifications

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

Novo Nordisk is an Equal Opportunity Employer/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 2/21/2019

DIRECTOR, COMPLIANCE OPERATIONS - Jazz Pharmaceuticals

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.

Responsibilities:
The Director, Compliance Operations is a key member of the Compliance Operations team. This position is responsible for monitoring the external risk and regulatory environment and assisting the Chief Compliance Officer and Deputy Chief Compliance Officer in modifying, as necessary, the Company's corporate compliance program. He or she will help to create and implement appropriate, risk-based compliance policies and procedures and monitoring, auditing and training programs in support of the Commercial, Medical, Clinical and Regulatory functions. This role requires engagement and strong working relationships with members of other teams and functions. He or she must have a solid understanding of the laws and regulations applicable to pharmaceutical companies.

Essential Functions
The Director, Compliance Operations:

  • Serves as a key member of the Compliance Operations team responsible for the day-to-day operation of the Company's corporate compliance program to meet changing needs;
  • Monitors the external risk and regulatory environment and suggests and helps to implement any needed modifications to the Company's corporate compliance program;
  • Assists the Deputy Chief Compliance Officer with development and implementation of the company's risk assessment process; and
  • Assists the Deputy Chief Compliance Officer and Chief Compliance Officer with development and execution of all aspects of the annual compliance work plan, including development and revision of written policies and SOPs, applicable training programs, and effective auditing and monitoring programs.

Required Knowledge, Skills, and Abilities

  • Significant knowledge of and experience advising business partners on compliance matters, particularly with regard to interaction with healthcare professionals, marketing strategies, promotional tactics and materials, fraud and abuse, anti-kickback and other compliance matters.
  • Ability to oversee and manage cross-functional issues and projects with team members at all levels of the organization.
  • Ability to prioritize conflicting demands and priorities from multiple business functions and handling heavy workload.
  • Team player with strong interpersonal skills.
  • Strong oral and written communication skills, including demonstrated ability to draft company polices and SOPs.
  • 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

Required/Preferred Education and Licenses

  • Bachelor's degree required.
  • Minimum of 5 years' industry-related experience in healthcare corporate compliance with demonstrated understanding of applicable legal, regulatory and compliance matters affecting global pharmaceutical companies with approved products.

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 2/19/2019

DIRECTOR, COMPLIANCE - Seattle Genetics
Reports to: VP and Compliance Officer
Location: Bothell, WA
Department: Compliance
Last Updated: November 1, 2018

Seattle Genetics is an emerging global multi-product biotechnology company that develops and commercializes innovative antibody-based therapies for the treatment of cancer. The company's industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. In addition to one marketed product, we are advancing a strong product pipeline of novel therapies for solid tumors and blood related cancers designed to address significant unmet medical needs and improve treatment outcomes for patients. More information about Seattle Genetics can be found at www.seattlegenetics.com.

Position Summary
We are currently seeking a Corporate Compliance professional with pharmaceutical/biotech industry experience. The position will report to the VP and Global Compliance Officer (CO) and will be responsible for the US and Canada Corporate Compliance Programs. This position manages and maintains oversight of the Compliance Program, with significant interaction with the Sales and Marketing, Legal, Information Technology, Medical Affairs, and other company departments. The Director of Compliance works to continuously enhance Seagen's Compliance program based on the legal enforcement environment through application of best practices in the life sciences Compliance space.

Principal Responsibilities

  • Provide strategic direction for the US and Canada Compliance function across all OIG seven elements of an effective compliance program leveraging knowledge of industry best practices.
  • Partner with and advise business stakeholders to prepare an annual compliance work plan based upon a comprehensive, annual compliance risk assessment.
  • Proactively plan for emerging trends in compliance, anticipate the impact on processes, and work with business stakeholders to determine how to address them using the most up to date information around emerging state and federal laws, U.S. government enforcement actions, evaluation of Corporate Integrity Agreements, etc.
  • Advise and provide support to business functions to maintain an internal infrastructure that supports a culture of compliance and recognizes that compliance is a collective responsibility of all employees.
  • Establish strong relationships with key internal stakeholders to understand current and future compliance needs.
  • Maintain a current working knowledge of various laws, regulations, and industry guidance that affect the corporate-wide compliance program, including federal and state government price reporting laws, state and federal privacy laws including GDPR, OIG and DOJ guidelines, PhRMA code and state marketing compliance laws.
  • Provide guidance to the Business and integrate compliance controls into the scope of existing business practices where applicable.
  • Partner with corporate compliance investigations regarding potential violations of compliance policies, laws or regulations and oversee corrective actions with business functions.
  • Work with internal Compliance Audit to develop annual audit plans for the business and work with the business to timely complete corrective action plans.
  • Work with internal Compliance Risk Assessment to complete implementation of Seagen's Risk Assessment process and assist business with ongoing updates of the Risk Assessment.
  • Primary Business Partner to Commercial and Medical in regards to initiatives of the Legal and the Compliance Policy/Training function

Qualifications

  • 7-10 years of recent, relevant in-house experience in a pharmaceutical or biotechnology company's compliance department is required
  • Knowledge of and experience with US and Canadian laws, regulations, and industry guidance that affect the pharmaceutical industry.
  • Effective public speaking skills and an ability to communicate in both verbal and written form with multiple stakeholders within and outside the company.
  • Ability to lead and work effectively with cross-functional teams and projects.
  • Strategic leadership capability, strong organizational awareness, sound judgment, strong business acumen and ability to make decisions with input from multiple stakeholders.
  • Strong problem solving and risk analysis skills.
  • Sound judgment and commitment to ethical conduct.
  • Ability to effectively prioritize and work in a fast-paced environment and to handle multiple complex and confidential tasks.
  • Ability to travel as necessary

Education

  • Bachelor's degree required
  • JD or other advanced degree preferred.

Competencies

  • Dealing with ambiguity
  • Comfort around higher management
  • Manages complexity
  • Customer focus
  • Decision quality
  • Business acumen
  • Negotiating
  • Problem solving
  • Drive for results
  • Strategic agility

As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.
 Apply here
Posted 2/18/2019

SENIOR MANAGER, U.S. HEALTHCARE COMPLIANCE - Clovis Oncology
Location: Boulder, CO

Job Summary
The Senior Manager, U.S. Healthcare Compliance will work with the Clovis legal and compliance team to provide guidance and support across the lifecycle of Clovis' products, including pipeline, commercial and medical affairs functions, with a specific focus on designing, implementing, and overseeing the training and enforcement of healthcare compliance policies and programs.

Job Responsibilities

  • Operationalizing compliance policies by leading in the design, development, and implementation of SOPs and program controls;
  • Developing and providing training to internal clients, partners, and stakeholders on key compliance policies and procedures;
  • Conducting Monitoring and Auditing of Clovis transactions and interactions with the healthcare community;
  • Identifying specific compliance risk areas to incorporate into the company compliance plan;
  • Serving as a standing or ad hoc member of business or leadership teams and providing compliance input and expertise into business decisions, including the development of solutions-oriented risk mitigation strategies;
  • Reviewing business materials (including brand plans, promotions, medical plans, training documents) requiring compliance operational input and advising internal clients, partners and stakeholders on compliant strategies, plans and tactics;
  • Conducting and managing compliance investigations regarding allegations of compliance and/or ethical policy deviations as well as the resulting corrective action plans.

Qualifications

  • Demonstrated knowledge of key biotech/pharmaceutical compliance laws, regulations and industry standards applicable to interactions with healthcare professionals by pharmaceutical manufacturers (e.g., anti-kickback, healthcare fraud and abuse, off-label promotion, transparency, PhRMA Code);
  • Strong program-management, operational, analytical, and technical expertise to effectively design, develop and implement healthcare compliance processes, controls, and workflows;
  • Demonstrated track record of partnering with business management to provide guidance and implementation of effective compliance processes;
  • Capable of working in a fast-paced environment while addressing risks collaboratively and with solutions that are company-appropriate;
  • Exceptional critical thinking and problem-solving skills;
  • Capable of managing and prioritizing multiple tasks and objectives;
  • Strong verbal and written business communication skills.

Education and Experience

  • Minimum of 8+ years of experience in the biotech/pharmaceutical or medical device industry, with at least 3-6 years of relevant work experience in the healthcare compliance field; pharmaceutical/biotech and/or medical device industry;
  • Bachelor's degree is required;
  • Science or accounting background a plus.

Working Conditions

  • Office-based, up to approximately 30% travel.

Please submit your resume and cover letter.
 Apply here
Posted 1/23/2019