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DIRECTOR, COMPLIANCE - Seattle Genetics
Reports to: VP and Compliance Officer
Location: Bothell, WA
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.
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.
- 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
- 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
- Bachelor's degree required
- JD or other advanced degree preferred.
- Dealing with ambiguity
- Comfort around higher management
- Manages complexity
- Customer focus
- Decision quality
- Business acumen
- 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.
SENIOR MANAGER, U.S. HEALTHCARE COMPLIANCE - Clovis Oncology
Location: Boulder, CO
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.
- 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.
- 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.
- Office-based, up to approximately 30% travel.
Please submit your resume and cover letter.
ASSOCIATE DIRECTOR COMMERCIAL COMPLIANCE BUSINESS PARTNER - Boehringer Ingelheim
Location: Ridgefield, CT
To assist in the development, implementation, and continuous improvement of an effective compliance program for all business activities within Commercial. To support the risk assessment and analysis process to continuously evaluate risk areas and priorities to guide new Compliance efforts. To act as a business partner to Commercial Departments to provide assistance and advice on daily operations and ensure appropriate compliance controls and training, as well as investigations of non-compliant activity and corrective action for identified business activities. To work closely with other teams within the Ethics and Compliance Department to ensure consistent application and implementation of identified compliance controls, training, monitoring, and auditing.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities:
- Participates in strategic planning for applicable organizational activities with the goal of providing compliance expertise and advice to ensure planning is efficient and considers compliance issues up-front. Also provides day-to-day support, advice and problem-solving expertise to applicable businesses to ensure business operations are conducted in full compliance with all relevant policies and procedures. Develops resources for applicable business areas, as needed, to help meet their respective compliance business needs. Monitors the external environment and recommends improvements to the company's compliance program based on identified industry best practices.
- Provides compliance expertise and guidance to Commercial business partners to enable decision-making that stays within ethical boundaries while still optimizing business performance. Acts as a liaison with BI GmbH business and compliance colleagues to influence the conduct of global activities that implicate US laws and regulations.
- Assesses training needs for business groups, provides input into training plans, and collaborates with appropriate individuals to develop training content, acting as subject matter expert for business area. Facilitates and delivers training as appropriate. Educates business groups in a way that closes knowledge gaps and addresses larger trends.
- Collaborates with personnel responsible for auditing plans to execute the auditing plan, including developing and executing action plans for identified CAPAs (Corrective and Preventative Actions) and monitoring established controls after implementation. Analyzes auditing results to recommend improvements in Compliance or business operations. Supports other activities of Commercial, including risk assessment and strategic planning, training and communication, health care provider interaction initiatives (i.e., implementation of fair market value, Sunshine Act requirements), and development of ethical business culture.
- Collaborate with internal OEC team members to identify areas of compliance risk in respective business areas, including but not limited to topics of Transparency & Disclosure, CIA, Anti-Bribery and Anti-Corruption (ABAC), and compliance operations, and ensure that systems, policies, procedures, training and other resources are coordinated to mitigate risk to impacted business areas. Effectively communicate and collaborate with OEC team members to ensure business and compliance objectives are met. Assist business in remediating findings from investigations, audits, monitoring and other OEC assessments, keep applicable OEC members apprised of relevant information from IRCs, CAPAs, and day to day business issues that impact OEC initiatives.
- Bachelor's degree is required.
- One (1) to three (3) years' experience leading employees and projects.
- Minimum of five (5) years Pharma and/or related experience.
- Must be legally authorized to work in the United States without restriction.
- Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background
- 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.
SENIOR MANAGER FOR MEDICAL & SCIENTIFIC COMPLIANCE - Ferring Pharmaceuticals
Location: Parsippany, NJ
Ferring Pharmaceuticals is a globally recognized, research-driven, biopharmaceutical company with more than 65 years of history. Headquartered in Switzerland, Ferring is privately owned with over 5,700 employees in nearly 60 countries. In the United States, Ferring identifies, develops and markets innovative products in the fields of reproductive health (infertility), urology, gastroenterology, endocrinology, women's health (obstetrics/gynecology) and orthopedics. Ferring's US operations employ approximately 800 people.
People Come First At Ferring. The Ferring Philosophy places people at the heart of what we do. This guides our relations with patients, physicians, employees, and other stakeholders. We invite you to share our passion for people and the power of science.
The Senior Manager for Medical & Scientific Compliance will be responsible for providing compliance guidance, training, and policies for the conduct of medical and research & development related activities and scientific materials in adherence with applicable regulations, guidelines, industry standards and best practices. Senior Manager will act as the compliance lead across regulatory, medical and scientific initiatives from concept to implementation for Medical, Medical Affairs, MSL, and R&D teams across Ferring and our partners. Role will coordinate and draw on resources from other functions including the broader Compliance Department, including other senior leaders in that function, and through ongoing collaboration with the Medical and R&D Teams.
- Provide sound Compliance advice and guidance on non-promotional materials, scientific exchange, disease state, regulatory, medical/scientific programs and R&D activities to minimize company risk and facilitate adherence in alignment with applicable regulations
- Develop and execute an engagement and integration plan for US Compliance, and Global Compliance to incorporate requirements and training into all client groups, and vendors, involved with medical and scientific operations
- Create, implement and monitor an operational and effective Compliance program for policies and procedures in a manner consistent with best practices and applicable laws and guidance
- Partner with the business support teams, including Legal, Regulatory, and Human Resources, to establish Compliance requirements and guidelines
- Provide input on Compliance matters to present to key stakeholders and senior leadership
- Foster a Company culture that focuses on Compliance and ensures on-going commitment to the Ferring Philosophy
- Develop and maintain SOPs, guidelines, policies and associated internal communications and materials related to non-promotional, Regulatory and medical/scientific programs, including congress activity, clinical symposia, publications, reprints, medical information, advisory boards, ad hoc consulting, IITs, CTs, etc.
- Liaise with company research entities as well as Global departments to ensure transparency and disclosure reporting and other relevant Compliance policies and processes are being communicated, and in adherence
- Represent Compliance as the primary point of contact for the evaluation and implementation of SOPs and policies with functional impact and contribute to related standards and guidelines for the review of concepts and activities based on analyses and risks assessments or other areas of potential vulnerability
- Act as the Compliance lead with all Medical, Scientific, Research and Development activities, including MSLs; from concept to field implementation and serve as the primary Compliance authority on Corporate Contributions, Ed Grants, IITs, Publication, and other elated and scientific team meetings and committees
- 4+ years of pharmaceutical industry experience, with Compliance, Legal, Medical, or Regulatory experience preferred
- Bachelor Degree required
- In depth understanding of PhRMA Code; Federal Food, Drug, Cosmetic Act; Anti-Kickback Statute; OIG Seven Elements; and federal and state transparency and disclosure laws.
- Strong knowledge of industry compliance activities, regulatory landscape, pharmaceutical compliance training and monitoring programs and best practices
- Experience in directly implementing and managing risked-based compliance programs and understanding of US pharmaceutical and other regulations.
- Works well across multiple functions and therapeutic areas
- Demonstrated ability to develop, launch, deliver, and measure various forms of training.
- Proficient computer skills: Microsoft Word/Excel/Office/Power Point, Lotus Notes, etc.
SENIOR COMPLIANCE OPERATIONS MANAGER - Exelixis
Salary Grade: 10
Division: G & A
Job Code: TBD
Department: Healthcare Compliance
FLSA Status: Exempt
Reports To: VP, Compliance
Effective Date: January 2019
The Senior Compliance Operations Manager will assist in maintaining and enhancing Exelixis' Compliance Program. More specifically, the individual will be responsible for developing, implementing, communicating and maintaining healthcare compliance policies, practices, systems, and processes, with an emphasis on business integrity, operational excellence, and practicality. The focus will be on managing a policy strategy, including policy development and associated ethics and compliance training, and supporting compliance-related investigations as well as implementation of corrective actions. The Senior Compliance Operations Manager must also have knowledge of, and experience in, conducting compliance auditing & monitoring activities. The essential business partners for this function are corresponding positions in Sales, Marketing, Market Access, Medical Affairs, HR, and Finance.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Promote ethics & compliance under Exelixis' Compliance Program through identification of compliance policy and training needs and development of new and enhanced compliance program activities.
- Lead and assist in developing and delivering effective and creative training, including written materials, computer-based instruction, and live presentations that leverage adult learning principles and foster greater engagement. This work will require periodic review and standardization of the ethics & compliance training curriculum to ensure consistency and the use of effective teaching methods.
- Serve as department administrator of the company learning management system and develop innovative compliance tools (e.g., game-based training), aids, and resources to guide ethical decision-making and behavior.
- Collaborate with key functional area stakeholders to identify risks and issues that may require training and monitoring, and ensure maintenance of policies, processes and investigative protocols on an ongoing basis.
- Acts as a consultant, reviewer and legal/compliance approver as needed, for business activities that involve Healthcare Compliance risks, and contributes to departmental process and organizational improvements and development, including management of the contract request process for HCP engagements.
- Support investigations of potential violations of law or company policy and/or ethical standards related to healthcare ethics and compliance matters, provide competent reports on the results of the investigations, and assist with the determination of corrective actions and the implementation of follow up actions.
- Conduct root cause analysis to understand factors contributing to potential policy violations, develop recommendations, and assist with the design of controls and standards for identified gaps from audit and monitoring activities.
- Develop and facilitate implementation of corrective action protocols for detected deviations from policy or applicable requirements.
- Leverage investigative analytics to share actionable insights with key stakeholders. This includes creating trending analysis and the management and utilization of the investigative case matter management system to drive program improvements and organizational understanding of compliance risks.
- Prepare timely, accurate, and complete reports with corrective action recommendations, including text summaries and graphical presentations of key data, and follow-through with key stakeholders for implementation.
- Assist in the audit and monitoring of company activities, including field ride-alongs, speaker programs, and advisory boards.
- Perform other duties as assigned/requested.
- BS/BA degree in related discipline and 10 years relevant industry experience, or;
- MS/MA degree in related discipline and 8 years of relevant industry experience; or,
- Equivalent combination of education and/or experience.
- CPA, CIA, CFE, CCEP certifications a plus.
- Prior training experience with demonstrated creativity in training programs required.
- Prior healthcare compliance related investigations experience with demonstrated independent oversight and significant caseload management required. Must have actual experience in conducting and leading investigations from commencement through to conclusion.
- Familiarity with the legal principles of FDA advertising and promotion regulations, the False Claims Act, Anti-Kickback Statute, OIG guidance, and the PhRMA Code required.
- Experience with Polaris software and/or Tableau is a plus.
- Excellent verbal and written communication skills, must be an effective communicator with strong interpersonal skills
- Strong organizational (detail oriented), project management, and problem-solving skills
- Ability to handle multiple tasks, prioritize appropriately and adapt quickly to new situations, and offer creative solutions to challenging problems
- Must be responsible, conscientious, and professional
- Ability to work under pressure to meet specific deadlines
- Ability to work independently and also be a team player
- Must be able to exercise common sense in carrying out tasks
- Dedication to quality and the highest professional standards
- Must be a self-starter and quick learner
- Must have good judgment
- Strong computer skills (e.g., Microsoft Office Suite (Word, Excel, PowerPoint, etc.), Visio, Internet)
- Ability to travel
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
SENIOR MANAGER, COMPLIANCE DEPARTMENT - Regeneron
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.
The Senior Manager, Compliance Department will assist the Director, Compliance and the Compliance Department in executing aspects of Regeneron's Compliance Program and ensuring full compliance will all applicable laws and regulations. Activities will include management and maintenance of all Compliance training delivered through the Learning Management System (LMS), assisting with written policies and procedures, assisting with development and execution of compliance communications and assistance with project management of all compliance related activities across the organization. Position will interact with departments across Regeneron and assist employees in understanding Regeneron compliance policies and procedures.
- Manage execution of new online compliance training through the LMS
- Manage on-going release of new hire on-line compliance training through LMS.
- Work closely with administrators to manage all on-line compliance training campaigns
- Analyze Compliance training completion rates and develop reports and recommendations as required
- Manage the tracking and documentation of Regeneron's Compliance program
- Assist with policy development and the creation of compliance tools to assist employees across the organization (e.g., PPTs, quick tips, job aids)
- Assist with developing, enhancing and delivering elements of Regeneron's on-going compliance communication strategy across the organization
Education and Experience
- Experience in LMS management, data analytics and overall healthcare law compliance
- 7+ years healthcare/pharmaceutical and/or biotech experience.
- Knowledge of federal fraud and abuse laws, including ACCME guidelines, the Office of Inspector General reports, and the Food, Drug and Cosmetic Act and an understanding of the roles and authority of government agencies and industry cooperative groups including FDA, OIG, and PhRMA.
- Knowledge of the Physician Payments Sunshine Act and aggregate spend reporting requirements
- Exceptional communication skills, including presentation capabilities, interpersonal skills and conflict resolution.
- Excellent negotiation skills requiring exceptional interpersonal communication and oral and written communication skills.
- Ability to persuade with verbal and written communications involving multiple key client groups.
- Ability to maintain an independent and objective perspective while developing and maintaining a strong partnership with the client organizations.
- Exceptional data analytic skills with advanced Excel experience
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
SENIOR MANAGER, COMPLIANCE OPERATIONS - Jazz Pharmaceuticals
Job Location: US-PA-Philadelphia
Job ID: 2018-3959
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.
The Senior Manager, Compliance Operations is a critical member of the Compliance Operations team. This position is responsible for leading the implementation of various special projects as directed by the Deputy Chief Compliance Officer and Chief Compliance Officer. Such projects include implementing special audit protocols, overseeing development of significant new policies and processes and development of new training programs, some or all of which are driven by changes in the external risk environment or new regulatory requirements. The successful candidate will develop and implement the overall project plans for these projects and assign tasks and monitor progress against those tasks as well as prepare reports summarizing status and progress of such projects.
The Senior Manager, Compliance Operations serves as a day-to-day project manager for implementation and oversight of special projects which may be driven by changes in external risk environment or new regulatory requirements, including:
- Ensuring appropriate policies and procedures are implemented;
- Ensuring that training and education occurs consistent with the special project plan;
- Assisting the Deputy Chief Compliance Officer and the Chief Compliance Officer in developing and implementing a risk assessment and mitigation program;
- Assisting the Deputy Chief Compliance Officer in reviewing and enhancing the Company's process to conduct appropriate screening and background checks for employees, contract workers and vendors, where appropriate; and
- Assisting the Deputy Chief Compliance Officer and the Chief Compliance Officer in the preparation of reports summarizing any of the special projects overseen by the Senior Manager, Compliance Operations.
Required Knowledge, Skills, and Abilities
- Significant knowledge and understanding of compliance matters, particularly with regard to interaction with healthcare professionals, fraud and abuse, anti-kickback and other compliance matters.
- Ability to develop and effectively implement a project plan across the company and ensure adherence to budgets, schedules, work plans and performance requirements.
- Ability to oversee and manage cross-functional issues and projects with team members at all levels of the organization.
- Ability to resolve a wide range of issues in creative ways.
- Ability to assign tasks, set deadlines and monitor and summarize progress of completion of those tasks.
- Ability to change the thinking of or gain acceptance from others in sensitive situations, without damage to the relationship.
- Ability to prioritize conflicting demands and priorities and manage heavy workload.
- Ability to manage external consultants and vendors engaged to assist in conducting special projects.
- Team player with strong interpersonal skills.
- Strong oral and written communication skills.
- Ability to work collaboratively and independently as the circumstances require.
- Self-motivated and detail-oriented.
- Position may be based in Philadelphia, PA or Palo Alto, CA.
- Solid organizational skills including attention to detail and multitasking skills.
Required/Preferred Education and Licenses
- Bachelor's degree required.
- Minimum of 3 years' industry-related experience in healthcare corporate compliance with demonstrated ability to manage complex projects and teams.
- Experience working under a corporate integrity agreement preferred.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
DIRECTOR/COMPLIANCE COUNSEL - Heron Therapeutics
Location: San Diego, CA
This position supports the compliance function and will be responsible for assisting in the development, execution and continuous improvement of the compliance program to ensure compliance with all applicable standards, laws, and regulations, including without limitation the U.S. Anti-Kickback Statutes, the False Claims Act, the Stark Laws, the Sunshine Act (Open Payments), the FCPA and HIPAA. This position will support the Chief Compliance Officer with respect to commercial legal and compliance matters and activities as well as other Legal projects as needed.
ESSENTIAL DUTIES & RESPONSIBILITIES:
- Monitors activity to help ensure compliance with PhRMA Code with respect to HCP interactions
- Provide advice and training to employees of the Company on the health care compliance program using a solid understanding of U.S. pharmaceutical laws, including regulatory and compliance issues and laws pertaining to interactions with healthcare providers
- Provide legal support for wide range of commercial and medical affairs activities related to product launch and ongoing promotion of pharmaceutical products
- Provide legal guidance to Promotional Review Committee
- Provide legal guidance to Medical Review Committee
- Provide legal guidance to Grants Committee
- Stay current on applicable law, regulation, and practice and communicating senior management apprised of current developments
- Minimum of 3-5 years relevant commercial compliance experience, including prior in-house experience with a biotech/pharmaceutical company
- BA/BS degree and JD required
- A solid understanding of U.S. pharmaceutical laws, including regulatory and compliance issues
- A solid understanding of laws pertaining to interactions with healthcare providers (Anti-Kickback, False Claims etc.)
- Ability to handle highly confidential and sensitive materials and information with complete discretion
- Ability to provide commercial contracting support also strongly preferred
- Ability to work with external counsel, vendors and business partners
- Ability to work within a very small legal/compliance department, and establish and maintain relationships across multiple corporate functions
- Adaptable and flexible, able to prioritize duties and manage multiple matters from start to finish with minimal supervision
- Exceptional attention to detail and excellent organizational skills and the ability to work on a variety of tasks and projects simultaneously with minimal supervision.
- Ability to work cooperatively and collaboratively with all functions and levels of the Company
- Proven ability to communicate effectively in a variety of difficult and sensitive situations
- Ability to thrive in a dynamic and past-paced environment
The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.
Send resume to: firstname.lastname@example.org.
MANAGER, COMPLIANCE - Horizon Pharma
Lake Forest, IL
Working at Horizon Pharma is more than a job - it's personal. We define success by a different set of numbers: the number of lives touched, the number of lives changed, the number of lives saved. We're a team of agile, out-of-the-box thinkers who are inspired to do more because we know we're a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help patients live up to theirs.
Seeking an experienced compliance professional responsible for supporting Horizon's compliance department.The Manager, Compliance possess working knowledge of the current healthcare compliance environment and pharmaceutical industry.This role will be responsible for global transparency reporting obligations for the organization as well as compliance data analytics. In addition, the role will assist with compliance program operations and provide policy guidance to the business.
- Manage the company's aggregate spend system and ensure applicable data are being captured and accurately reported for international, federal and state government transparency reporting purposes.
- Conduct aggregate spend system training for employees and vendors.
- Perform data analytics, data correction, and associated remedial action.
- Leverage aggregate spend data and additional company data sources to create compliance data monitoring dashboards and executive reports.
- Assist in development of policies and work instructions to reflect the processes associated with aggregate spend reporting and data analytics.
- Conduct field ride alongs and speaker program observations to monitor key compliance risk areas. Draft observation reports and identify corrective actions
- Provide advice and support to Sales, Marketing, Commercial Operations and other key business stakeholders.
- Assist in developing compliance training, compliance policy development, investigations, and auditing, as needed.
- Other duties as assigned.
Qualifications and Skills Required:
- Experience in the healthcare industry and experience with transparency reporting
- Strong MS Excel skills required
- Organized, analytical, and attention to detail required
- Ownership driven with a sense of urgency
- Ability to communicate and work effectively within a team, cross-functionally, and with leadership
- Must also be comfortable as a self- starter, creative thinker, and independent worker
- Ability to multi-task and be flexible in a changing and fast paced environment
- Comfortable speaking in public.
Horizon Pharma plc does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.
MANAGER - GOVERNMENT ACCOUNTABILITY - Novo Nordisk
About the Department
At Novo Nordisk, we're committed to building the best Compliance team in the pharmaceutical industry. Operating at the highest ethical standards and ensuring adherence to corporate and legal regulations, the Compliance team is constantly called upon to design and implement creative solutions to complex issues. From training on new procedures, to auditing against local and corporate policies, to reporting compliance-related issues, Compliance keeps us accountable every step of the way as we develop life-changing therapies and bring them to market. At Novo Nordisk, you will be part of a company respected equally for its financial results and its business ethics. Are you ready to make a difference?
This position is responsible for supporting the daily operational activities related to the Ethics & Compliance (E&C) Department's Government Accountability Program ("Program"). This position will be directly engaged with reviewing compliance with Federal PDMA obligations, local/state sample obligations, Drug/Sharp takeback compliance, and associated reporting. The position will also support other Programs as required. Additionally, this position will serve as the point of contact for E&C Department systems to interface with other Line of Business ("LoB") systems, ensuring compliance objectives are met and coordination between them to ensure the Program's effectiveness.
Reports to the Director - Government Accountability. Regularly interacts with all other functional E&C areas and LoB (e.g. Legal, Information Technology, Commercial Effectiveness, Clinical Operations, and Marketing Effectiveness). The position will also interact with external customers including Health Care Professionals (HCP), third party/external vendors, and external consultants. This position may interact with government officials. This position may manage employees in Novo Nordisk Inc (NNI's) Global Servicing Center in Bangalore.
- Supports the Director - Government Accountability in facilitating and raising awareness of the Program while fostering accountability for E&C program throughout the organization
- Maintains understanding of laws and regulations, enforcement actions and evolving practices relevant to pharmaceutical ethics & compliance and proposes updates to the Program, as appropriate
- Manages the review and timely reporting of all government requirements while understanding NNI, local and global impacts
- Responsible for creating and executing an Organizational Change Management (OCM) Plan for the Government Accountability programs
- Informs management of ethics & compliance issues in a timely manner while encouraging the flow of information between colleagues and LoB
- Actively works to identify, analyze, and mitigate potential business ethics and other risks to the organization
- Supports the Director with Business Assurance (BA) and Business Ethics & Compliance Office (BECO) collaborations regarding government requirements and integration of systems/data
- Supports NN affiliates (e.g., NNCI) with implementing and maintaining a government accountability program
- Recommends enhancements to systems, processes and technologies for government reporting
- Manages creation and continued maintenance of government accountability protocols and assumption documents to support accurate filings and internal documentation
- Conducts training to employees and third party vendors to timely communicate new government requirements or updated NN interpretations
- Supports the government accountability budget (e.g. forecasting expenditures, reporting variances, and ensuring responsible spending) as requested
- Maintains understanding of applicable laws and regulations, enforcement actions and evolving practices/trends relevant to pharmaceutical compliance
- Responsible for development of annual plan to strengthen NNI's confidence when attesting to government reports (e.g., sample transparency, compliance program attestations). Support remediation and mitigation activities as they relate to Government Accountability Ensure that controls are in place for reporting completeness, consistency, accuracy, and integrity to strengthen and support the sub-certification/attestation process
- Responsible for ensuring that E&C senior management is informed of compliance issues in a timely manner
- Additional responsibilities with Government Accountability or departmental operational impact as assigned
0-10% overnight travel required.
- A Bachelor's degree from an accredited institution required
- A minimum of 8 years combined pharmaceutical, legal, regulatory, and compliance experience required OR a minimum of 6 years' experience required if accompanied by an advanced degree or certificate (e.g. MBA, JD, PMP)
- Demonstrates functional knowledge and understanding of the Anti-kickback Statute, the False Claims Act, Food and Drug Administration (FDA) rules and regulations regarding the promotion of pharmaceuticals, government corporate integrity agreements, PhRMA and federal and state aggregate spend reporting requirements
- Knowledge and experience with pharmaceutical aggregate spend solutions and data associated with promotional and clinical data, preferred
- Experience working under a government agreement (e.g. CIA, DPA, Consent Decree) is required
- Demonstrates strong interpersonal skills and ability to influence at all levels of the organization
- Excellent communication and organization skills
- Excellent project management skills to oversee and drive project execution
- Ability to manage multiple projects concurrently and collaborate across several functional areas
- The ability to think objectively and use sound reasoning principles
- Ability to manage multiple projects to completion meeting internal and external deliverables with high degree of accuracy
- Excellent communication skills (written and verbal), strong report writing skills and organization skills are required
- Uncompromising ethics and high standard of personal integrity
- Ability to work proactively and independently with minimal supervision
- Proficiency in Microsoft Office Suite
- Supervisory experience preferred
Novo Nordisk is an Equal Opportunity Employer /F/Veteran/Disability/Sexual Orientation/Gender Identity.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
ETHICS AND COMPLIANCE MANAGER NA - Ipsen
Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company, focused on innovation and specialty care. At Ipsen, we've created a workplace that recognizes and promotes an entrepreneurial spirit in our employees, and are building a strong legacy of helping patients with difficult-to-treat diseases across oncology, neurosciences and rare diseases. We know we can only be better and smarter if we work diligently together as ONE Ipsen, across all functions and geographies. We strive to break down silos and empower teams to deliver effective therapeutic solutions through highly differentiated medicines for patients with unmet needs.
We take pride in our culture, which is rooted in collaboration, to deliver results for our core customer - the patient. This level of involvement by cross-functional teams promotes a strong sense of unity, and pulls together all colleagues locally and across our key geographies, which span 115 countries across North America, Europe and Asia. As a growing organization, Ipsen North America is comprised of our Cambridge, MA, Basking Ridge, NJ and Toronto, Canada locations, with employees supporting functions including Commercial Operations, R&D, Business Development and Technical Operations.
Our employees are the driving force behind our mission at Ipsen, and to sustain their passion and focus every day, we offer a wealth of fulfilling challenges and growth opportunities through unique leadership and training programs. At Ipsen, you will work alongside industry leaders and contribute within a fast-moving and truly game-changing global organization, recognized for its talent and patient solutions. At Ipsen, we're making hope a reality for the patients we serve.
This position is responsible for managing compliance processes, including the preparation, communication, implementation and monitoring of adherence to, policies and standards to promote compliance with legal and regulatory requirements. Provides compliance advice and support to the company, its subsidiaries and affiliates. Performs a variety of investigations, and follows-up on others, through resolution. Leads and/or participates in other compliance projects, as needed. The individual should enjoy working collaboratively with other functional areas and also be comfortable with a significant degree of autonomy. This is a great opportunity to be an integral part of a dynamic Ethics and Compliance group.
Responsibilities will include, but are not limited to, the following:
- Oversee implementation of compliance recommendations, including those that result from due diligence findings
- Lead risk assessments, work with internal audit to review program compliance, and utilize analytics to monitor it, identify areas of risk and prioritize risk mitigation
- Proficiency on federal, state and global legal/regulatory requirements and timely responds to field inquiries
- Work closely with the Transparency team to advise on compliance implications under the Sunshine Act
- Lead on implementation of compliance recommendations and documentation/records for commercial programs and initiatives
- Review and prepare documentation related to Anti-kickback and Sunshine controls - contracts and forms review
- Maintain library of anti-kickback and Sunshine compliance forms and provide them to operations for consistency
- Prepare dispute resolution procedures and advise on process
- Publish periodic FAQs and commercial guidance, as appropriate
- Lead training initiatives, and develop the respective materials within areas of responsibility
- Create guidelines and tools, and advise different cross-functional teams to ensure compliance
- Assist with other compliance work as needed (may involve international matters)
- Maintain a current working knowledge of various laws, regulations, and industry guidance that affect the corporate-wide compliance program, including federal and state government price reporting laws, fraud and abuse and anti-kickback statutes, OIG guidelines, industry codes in relevant markets including PhRMA, US state marketing compliance laws, FCPA, UK Bribery Act, and other anti-bribery laws.
Education and experience
- Bachelor's degree in related discipline.
- 5 + years of increasing responsibility and complexity in terms of any applicable professional experience
- 2-4 years of compliance experience
- Law degree a plus
- Graduate degree a plus
- Pharmaceutical industry experience required
Core Competencies (Specific knowledge, skills and abilities that enable an individual to effectively perform the job)
- Strong management skills and ability to attract, retain, motivate and develop junior team members for high performance
- Excellent verbal and written communication skills and ability to resolve disputes effectively
- Strong presentation and public speaking skills
- Ability to manage projects, risks, cost, time and project teams
- Work effectively with team members to achieve company goals in effective ways
- Strong planning and organizational skills and techniques
- Communicate effectively with management
- Good negotiating skills
- Build strong relationships, understand organizational complexities and manage conflict
- Broad professional and managerial skills with an understanding of industry practices and company policies and procedures
The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
Ipsen Biopharmaceuticals, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law.
Ipsen Biopharmaceuticals, Inc. conducts background screening, reference checks, and drug testing as part of its pre-employment screening process. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned.
All Employees are expected to adhere to all company policies and act as a role model for company values.
Note: This description is not intended to be construed as an exhaustive list of duties, responsibilities or requirement for the position. This position may change at any time and the employee may be requested to perform different or additional duties as assigned.