• Pfizer
  • $178,775.00 -178,775.00/year*
  • Spring Valley , NY
  • Scientific Research
  • Full-Time
  • 124 Maple Ave

The WRDM Compliance Lead is responsible for overseeing the execution of Pfizer's Compliance program for WRDM Research Units and Partner Lines globally. This position serves as the primary compliance advisor to the WRDM Leadership Team, including the Research Unit Chief Scientific Officers. The WRDM Compliance Lead also provides primary support to the Regulatory Affairs organization and Chief Development Officers within GPD. The WRDM Compliance Lead will have regular communication and coordination with attorneys in the Clinical Development, Business Transactions and Regulatory Law groups, as well as with colleagues in WRD Operations, GPD Business Operations and Sourcing, Corporate Audit, and Medical Quality Assurance.. The WRDM Compliance Lead also coordinates with the Compliance Investigations Team to provide subject matter expertise and remediation support for compliance investigations. The position reports to the Chief Compliance Officer, Science Medicine & Manufacturing, whose responsibilities include supporting the following organizations: WRDM, GPD, Medical, Medical Affairs, PGS, and EH&S. This colleague is the primary compliance resource responsible for mitigating key risks and providing proactive compliance support for key areas and policies in the WRDM Research organization and broader R&D enterprise including research integrity, clinical trial conduct and controls, conflicts of interest, protecting confidential information, non-clinical publications, HCP engagements, FCPA/MAPP, external funding, and non-interventional studies. The WRDM Compliance Lead also develops and supports compliance culture initiatives for R&D colleagues.. The WRDM Compliance Lead is a member of the WRDM Extended Leadership team, and also provides compliance support as a member of the Pan PEARL Governance Committee.. Role Responsibilities. Oversee and implement Pfizer's Compliance program for WRDM colleagues globally.. Manage and engage in proactive worldwide compliance activities for WRDM colleagues including: (i) identification, assessment and mitigation of risk; (ii) training and outreach efforts, including development and/or execution of training curriculum in key areas; (iii) anticipation of emerging trends and changes to the political, legal and regulatory landscape by working with the businesses and other colleagues; (iv) support implementation of corporate and divisional policies and procedures and the development of group or division-specific guidance or policies as needed; (v) development of additional tools and controls to drive compliance and enhance a culture of integrity; and (vi) support compliance certifications required under Pfizer policies and procedures.. Coordinate compliance-related communications, including updates to WRDM leadership on external enforcement environment activity and other compliance-related issues of importance, including investigations trends involving WRDM colleagues and enterprise-wide compliance initiatives.. Strategic advisor to the WRDM Chief Scientific Officers and Partner Line leads regarding compliance aspects of their activities and strategies to enable achievement of objectives while mitigating risk, fostering a culture of performance with integrity, and ensuring enterprise-wide consistency.. Provide compliance support and strategic advice to the Regulatory organization, including the Pan PEARL Governance Committee.. Provide compliance support to select organizations within GPD, including the Chief Development Officers.. Provide subject matter expertise, advice and counsel to colleagues in WRDM on topics including healthcare law and other compliance topics including HCP engagement, GPIHP, FCPA compliance, conflicts of interest, research integrity, and non-clinical publications and support the management of related R&D SOPs and guidance documents, as needed.. Work with the Global Investigations group to understand the docket of compliance investigations across R&D, communicate findings to senior leadership as needed including at the WRDM LT, and support remediation efforts, as needed and in coordination with the business.. Oversee proactive reviews and special projects designed to identify and mitigate compliance risks involving the R&D enterprise, as well as coordinate with Global Commercial Operations (GCO) and GCO Compliance and Legal support on cross-divisional SOPS and other cross-divisional compliance-related initiatives.. Provide compliance support and counsel as needed for WRDM business development transactions.. Provide support for integration activities that impact WRDM colleagues.. Qualifications. Excellent academic qualifications. JD or JD equivalent from US/EU preferred. Proven capabilities including 10+ years of experience in some or all of the following areas: healthcare or regulatory compliance, FCPA/ABAC, ethics and compliance, and the pharmaceutical industry. Strong business acumen and subject-matter expertise. Detail-oriented and strong organizational, communication, and presentation skills and ability to effectively convey compliance principles to non-legal and non-compliance colleagues. Demonstrated strength in leadership, judgment and initiative. Proven capabilities to set priorities, drive results, and act efficiently and effectively within a complex business and organizational environment. Investigations, negotiating skills and/or transaction experience a plus. Policy development experience a plus. Analytical and creative thinking ability. Availability for travel domestically and internationally, approximately 10-15% as needed.. Sunshine Act. Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.. EEO & Employment Eligibility. Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.. Other Job Details:. Last Date to Apply for Job: April 1, 2019. N (Other) (United States of America). Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.. Pfizer is a leading research-based biopharmaceutical company. We apply science and our global resources to deliver innovative therapies t...
Associated topics: bacteria, dietician, immunology, injury, medical, microbiological, pharmacometrics, protein, trauma, virus

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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