[{"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15634BR\nJob Posting Title Compliance Sr Mgr, Global Privacy and Data Protection, Policies, Training and Communication\nCareer Category Compliance\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Experienced Privacy Professional to work in the Worldwide Compliance and Business Ethics Department of a global pharmaceutical/biotechnology company (Company\u201d) located in Southern California. The individual will report directly to the Chief Privacy Officer and will:\n\n\u2022 Develop, lead and continuously improve, in collaboration with the Chief Privacy Officer, programmatic efforts designed to build effective global and cross-functional privacy and data protection controlled documents (including policies, procedures, templates and forms), training and communication in a manner conducive to the success of the business\n\u2022 Develop and maintain a multi-year plan outlining the strategy for development and execution of global and cross-functional privacy and data protection-related controlled documents, training and communication\n\u2022 Anticipate project challenges, troubleshoot, problem solve, recommend solutions\n\u2022 Author, update, maintain and serve as subject matter expert on privacy and data protection-related controlled documents, working objectively to analyze compliance issues or concerns\n\u2022 Develop and design comprehensive long-term sustainable role-based training curricula for privacy roles globally\n\u2022 Serve as a subject matter expert on both policy and training content for targeted and company-wide privacy and data protection-related training courses\n\u2022 Provide official interpretation of privacy and data protection-related controlled documents to stakeholders, as warranted, including the preparation of official clarifications or guidance documents based on appropriate inputs (such as legal, regulatory, and business inputs)\n\u2022 Perform research on privacy and data protection-related laws, regulations, and industry developments and interpret their impact on Company\u2019s business practices and policies\n\u2022 Engage with attorneys to ensure that privacy and data protection-related controlled documents, training and communication efforts meet legal and regulatory expectations and are implemented to support identified needs\n\u2022 Collaborate with local and international colleagues to develop appropriate and usable global and regional controlled documents, training and communications\n\u2022 Respond to Audit and Investigations findings by determining appropriate privacy and data protection-related actions based on audit requirements\n\u2022 Annually assess controlled documents and training to determine what revisions are warranted\n\u2022 Own and manage projects and reporting on progress, obstacles, and execution\n\u2022 Manage the ongoing revisions of controlled documents\n\u2022 Issue and track the issuance of controlled documents, both internally and with vendors and external service providers\n\u2022 Benchmark our privacy and data protection-related policies and training against those of our peers\n\u2022 Represent Global Privacy Office on corporate cross-functional working teams\n\u2022 Support the global privacy and data protection needs of Company\u2019s Global Operations and Manufacturing function\n\u2022 Prepare for and deliver regular management reviews and operating reviews\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 6 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree or & 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Responsibility for developing and implementing global, cross-functional policy, training and communications initiatives, including creation of global annual and multi-year plans\n\u2022 2+ years of relevant privacy experience at a law firm or global company\n\u2022 Strong working knowledge of global privacy and data protection laws and regulations\n\u2022 Substantial experience building and/or implementing global and cross-functional policy, training and communication efforts including annual/multi-year planning (global experience preferred)\n\u2022 Strong strategic thinking skills and ability to translate strategy into action plans\n\u2022 Excellent ability to interact and build relationships at all levels of management and staffing across organizational/jurisdictional boundaries\n\u2022 Ability to understand, plan and navigate in a matrix environment\n\u2022 Excellent project management skills\n\u2022 Excellent command of English (spoken and written) and public-speaking skills\n\u2022 Availability in crisis\n\u2022 Understanding of global aspect of position\n\u2022 Strong working knowledge of SharePoint, EDMQ and Articulate software and instructional design\n\u2022 Self-starter with a high level of initiative and strong work ethic\n\u2022 Significant experience working with senior management, including both internal and external law departments\n\u2022 Meaningful ability to effectively and timely manage multiple initiatives and cross-departmental projects (i.e., strong project management skills).\n\u2022 Proven ability to multi-task, thrive and deliver in a highly-regulated and increasingly-demanding matrixed corporate environment. Demonstrated ability to regularly re-prioritize risks, objectives and action plans based on an evolving corporate and regulatory landscape. Ability to deal well with ambiguity and complex situations.\n\u2022 Strong ability to synthesize vast amounts of complex data, and clearly and concisely articulate the relevant points at the right altitude.\n\u2022 Strong knowledge of applicable global privacy and data protection laws and regulations as well as ability to perform research to identify and interpret such laws and regulations.\n\u2022 Demonstrable political acumen to collaborate, drive results and influence cross-organizational stakeholders and decision makers with different operational and jurisdictional responsibilities.\n\u2022 Significant company representation (preferably public)\n\u2022 Proven communication, relationship-building and collaboration skills\n\u2022 Responsibility for building, improving and/or re-engineering projects and programs\n\u2022 Development and updating of intra- and internet content\n\u2022 Familiarity with in-house learning management systems\n\u2022 Crisis management and handling\n\u2022 Proven commitment to delivering high-quality and timely output\n\u2022 Proven to have a strong work ethic demonstrated by being self-starter, resourceful and able to participate in a highly collaborative team-oriented environment\n\nAdditional Competencies/Skills:\n\u2022 Effective leadership skills\n\u2022 Effective organizational and creative problem solving skills\n\u2022 Strong understanding of the role of compliance professionals\n\u2022 Healthcare/pharmaceutical company experience\n\u2022 CIPP certification from the International Association of Privacy Professionals\n\u2022 Willingness to travel", "date_new": "2012-05-21 18:12:06", "url": "http://www.amgen.jobs/xml/28833040/job", "country": "United States", "company": "Amgen", "title": "Compliance Sr Mgr, Global Privacy and Data Protection, Policies, Training and Communication", "reqid": "15634BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28833040}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15638BR\nJob Posting Title Compliance Sr Mgr, Global Privacy and Data Protection Incident, Inquiry, Monitoring and Reporting\nCareer Category Compliance\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description Experienced Privacy Professional to work in the Worldwide Compliance and Business Ethics Department of a global pharmaceutical/biotechnology company (Company\u201d) located in Southern California. The individual will: (1) report directly to the Chief Privacy Officer, (2) develop and lead, in collaboration with the Chief Privacy Officer, programmatic efforts designed to build an effective global privacy and data protection incident, inquiry, monitoring and reporting function, (3) collaborate and work directly with in-house and external attorneys responsible for global privacy and data protection, (4) interact with global senior Company management as well as governmental agencies; (7) lead and direct the data protection efforts undertaken by the internal team dedicated to identifying, containing and remediating any found privacy and/or data protection vulnerabilities; (8) implement and execute effective testing, auditing, monitoring, tracking and reporting procedures and programs to ensure the success of the program, as measured by regular assessments and metric-based analysis; (9) compile clear, accurate and timely reports for senior management and the Board of Directors, as needed; (10) to support the Chief Privacy Officer in preparing Operating and/or Management Reviews, as required; and (11) support the global privacy and data protection needs of Company\u2019s Global Research and Development function.\nBasic Qualifications \u2022 Doctorate degree & 2 years of directly related experience\nOR\n\u2022 Master\u2019s degree & 6 years of directly related experience\nOR\n\u2022 Bachelor\u2019s degree or & 8 years of directly related experience\nOR\n\u2022 Associate\u2019s degree & 10 years of directly related experience\nOR\n\u2022 High school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 Candidate should have legal training and 2+ years of relevant international privacy/data protection experience at a law firm or global company, including experience managing personal data incident inquiry and response efforts, implementing effective testing, monitoring, tracking and reporting procedures and programs, and compiling clear, accurate and timely reports for senior management including a Board of Directors\n\u2022 Health care/pharmaceutical company and multiple data stream (e.g., employee, vendor, customer, patient) experience, is a plus\n\u2022 Candidate should also possess a working knowledge of information technology/security capabilities\n\u2022 Experience should include meaningful project direction and coordination responsibility; significant experience working with senior management, including both internal and external law departments\n\u2022 Significant company representation (preferably public); and responsibility for global, cross-functional data protection initiatives\n\u2022 Candidate must be able to handle, prioritize and follow through on diverse issues on a timely basis. Candidate must be a self-starter and hard worker, resourceful and able to participate in a highly collaborative team-oriented environment.\n\u2022 Proven ability to effectively and timely manage multiple initiatives and cross-departmental projects (i.e., strong project management skills).\n\u2022 Proven ability to multi-task, thrive and deliver in a highly-regulated and increasingly-demanding matrixed corporate environment.\n\u2022 Demonstrated ability to regularly re-prioritize risks, objectives and action plans based on an evolving corporate and regulatory landscape.\n\u2022 Ability to deal well with ambiguity and complex situations.\n\u2022 Strong ability to synthesize vast amounts of complex data, and clearly and concisely articulate the relevant points at the right altitude.\u2022 Demonstrable political acumen to collaborate, drive results and influence cross-organizational stakeholders and decision makers with different operational and jurisdictional responsibilities.\n\u2022 Proven communication, relationship-building and collaboration skills.\n\u2022 Experience in building programs, process improvements and/or re-engineering.\n\u2022 Experienced in crisis management and handling.\n\u2022 Proven commitment to delivering quality and timely output.\n\u2022 Legal training\n\u2022 2+ years of relevant privacy experience at a law firm or global company\n\u2022 Strong awareness of global privacy laws and regulations and experience with associated compliance\n\u2022 Substantial experience building and/or implementing operational privacy and data protection programs in a corporate environment (global experience preferred)\n\u2022 Strong strategic thinking skills and ability to translate strategy into action plans\n\u2022 Excellent ability to interact and build relationships at all levels of management and staffing across organizational/jurisdictional boundaries\n\u2022 Ability to understand, plan and navigate in a matrixed environment\n\u2022 Excellent project management skills\n\u2022 Excellent command of English (spoken and written) and public-speaking skills\n\u2022 Availability in crisis\n\u2022 Strong working knowledge of information technology systems would be an advantage\n\u2022 Understanding of global aspect of position\n\u2022 Effective leadership skills\n\u2022 Effective organizational and creative problem solving skills\n\u2022 Self-starter with a high level of initiative and strong work ethic\n\u2022 Strong understanding of the role of compliance professionals\n\u2022 Healthcare/pharmaceutical company experience", "date_new": "2012-05-21 18:11:30", "url": "http://www.amgen.jobs/xml/28833012/job", "country": "United States", "company": "Amgen", "title": "Compliance Sr Mgr, Global Privacy and Data Protection Incident, Inquiry, Monitoring and Reporting", "reqid": "15638BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28833012}, {"country_short": "USA", "city": "Thousand Oaks", "description": "Auto req 15397BR\nJob Posting Title Exec Dir Compliance\nCareer Category Compliance\nEmployee Subgroup Executive FT\nCountry (State/Region) United States - California\nLocation (City) Thousand Oaks\nAmgen Job Description The Executive Director Compliance role is responsible for planning, organizing, and directing all activities related to ensuring the R&D organization\u2019s compliance with regulations and requirements specifically managing the R&D audit functions and compliance advice activities.\n\nKey responsibilities for this position include:\n\n\u2022 Conceives and directs audit and compliance strategies designed to ensure acceptability of regulatory applications and compliance of post marketing activities (pharmacovigilance and labeling)\n\u2022 Provides comprehensive assurance that activities regulated by good pharmacovigilance practices (GPvP), good clinical practices (GCP) , and Good Laboratory practices (GLP) are compliant with external regulatory guidelines and internal company policies and procedures.\n\u2022 Ensure Senior Management is informed of all critical compliance issues in a timely manner; aggregate issues on an ongoing, periodic basis\n\u2022 Lead, manage and motivate a team of approximately fifty staff.\n\u2022 Collaborate with the R&D organization to develop best practices and provide guidance as necessary to ensure compliance across teams\n\u2022 Evaluate the need for, and oversight of audits of external investigator sites, vendors, and internal processes including documentation systems and compliance with appropriate regulations\n\u2022 Develops and implements risk management processes used to establish the need for compliance, assign appropriate priority to efforts, and allocate appropriate resources needed to ensure full compliance.\n\u2022 Monitor, evaluate, and manage the resource implications resulting from regulatory inspections and the rapid growth of regulated systems.\n\u2022 Assure effective management of all R&D regulatory authority inspections and advise development teams regarding effective management of clinical site and/or vendor inspections\n\u2022 Identify and follow up on corrective action plans arising from audits involving training as necessary\n\u2022 Engage with leaders in other compliance organizations within Amgen\n\u2022 Contributes to the overall strategy of the Commercialization and R&D Compliance organization.\nBasic Qualifications \u2022 6 years of direct managerial and/or leadership experience, AND\n\u2022 Doctorate degree & 6 years of directly related experience, OR\n\u2022 Master\u2019s degree & 10 years of directly related experience, OR\n\u2022 Bachelor\u2019s degree & 12 years of directly related experience\nPreferred Qualifications \u2022 JD or MBA\n\u2022 10 years experience managing compliance and/or regulatory affairs or legal teams in a major pharmaceutical or biotech company, including GCP and GLP\n\u2022 Excellent working knowledge of US and Global regulations pertaining to GCP, GLP, CFR, ICH, MHRA Pharmacovigilance inspection program.\n\u2022 Knowledge in GMP, pharmacovigilance, healthcare compliance and research compliance desirable\n\u2022 Experience in other related areas of compliance including OIG, GMP\n\u2022 Proven communication skills; teamwork and negotiation skills; ability to work through conflicting situations\n\u2022 Excellent technical writing skills\n\nCompetencies\n\nTo perform the job successfully, an individual should demonstrate the following competencies:\n\n\u2022 High level of organizational skills and flexibility with the ability to prioritize\n\u2022 Ability to integrate company goals and strategies with compliance requirements\n\u2022 Strong knowledge in the areas of medical and regulatory affairs and the drug development process\n\u2022 Strong ability to champion\u201d internal policies for audit internal procedures.\n\u2022 Ability to communicate effectively orally and in writing.\n\u2022 Ability to gather information from multiple sources to understand problems; strong problem solving abilities.\n\u2022 Demonstrated leadership ability.\n\u2022 Ability to maintain confidentiality at all times is required.", "date_new": "2012-04-25 21:11:44", "url": "http://www.amgen.jobs/xml/28183917/job", "country": "United States", "company": "Amgen", "title": "Exec Dir Compliance", "reqid": "15397BR", "state": "California", "state_short": "CA", "location": "Thousand Oaks, CA", "uid": 28183917}]