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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
- 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
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
HEALTH CARE COMPLIANCE SENIOR MANAGER - Actelion Pharmaceuticals Ltd.
Job Number: 7028190215
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.
- 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.
North America-United States-California-San Francisco
Janssen Pharmaceuticals, Inc (6062)
Health Care Compliance
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 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.
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)).
- 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
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 (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.
DIRECTOR, COMPLIANCE OPERATIONS - Jazz Pharmaceuticals
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 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.
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.
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.