Senior Manager-Medical & Affiliates-R&D Quality Jobs in USA, NJ, Parsippany | Rose International Job
Rose International
Parsippany, NJ
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JOB DETAILS
SALARY
$58–$68 Per Hour
JOB TYPE
Temporary
LOCATION
Parsippany, NJ
POSTED
3 days ago
Required Education:BA/BS with 3+ years’ relevant experienceRequired Skills:Relevant experience in quality, compliance, governance and risk management in the biopharmaceutical or related industryDemonstrated critical thinking skillsFamiliarity with post-marketing medical affairs operations and activitiesGeneral understanding of the PhRMA code regulations, standards, and business requirementsEffective communication and interpersonal skillsExcellent organizational and project management skillsPreferred Skills:Demonstrated critical thinking skills and ability to define and implement quality and compliance constructs, standards, metrics, and practices that drive quality and compliance across cross-functional operations and activitiesEffective communication and interpersonal skills, to include developing relationships across organizational levelsExcellent organizational and project management skillsPrevious people-management experience and a track record of effective leadership, whether through direct line or matrix team managementSummary:Would you like to play a crucial role in developing life-saving therapies? Are you excited to use your pharma business expertise to partner with internal teams and external partners as we strive to cure unmet medical needs?Seeking a Sr. Manager/Associate Director of Medical & Affiliates Research & Development (R&D) Quality to play a pivotal role in reinforcing and sustaining a strong culture of quality, compliance, governance, and risk management for our cross-therapeutic area medical affairs activities.The Sr. Manager/Associate Director will support Medical & Affiliates R&D Quality operations by promoting document management, monitoring initiatives, independent projects and learning solutions that are managed by R&D Quality Process, Documentation and Learning to advance a culture of quality and compliance across Client.Client R&D Quality and the Medical Governance & Affiliates team is a phenomenal place to develop your skills and expertise.Our strong pipeline of therapies will provide you opportunities to be challenged and stretched while supported and developed by our diverse and expert team.We are a committed team of highly skilled Quality professionals dedicated to helping deliver life-saving therapies for unmet needs. We bring our passion for science, discovery, and creative thinking into everything we do.We are an inclusive and diverse community, who are supported by strong leaders that are committed to giving each of us a voice while achieving our mission. Our collaborative and supportive structure will help you develop your skills, experience, and your career.Are you ready to explore how you can play a vital role on the team and help deliver life-saving therapies to patients around the world?Responsibilities:Primary Responsibilities:Partner with Medical & Affiliates Quality Business Partner team to support the ecosystem of medical affairs and Affiliates’ quality operations, including:Synthesizing Quality issues arising from deviations, inspections, and audits; supporting the development and maintenance of Medical Affairs (MA) process documentationCreating analytic tools to enhance data insights and leadership communicationsSupporting initiatives and projects led by Quality Business Partners in collaboration with the businessDeveloping sophisticated presentations to support project execution and decision makingThe role requires the ability to remain flexible and effectively manage multiple priorities simultaneously. Pharmaceutical industry experience is preferred.Audits, Inspections & Self-AssessmentsSupport team needs in their conduct audits, inspections, and self-assessment activities in coordination with functional business partnersSupport internal audit and regulatory inspection deliverables, including readiness preparation, inspection execution, and response activities, as neededAssist with the resolution of relevant audit and inspection findings and the implementation of corrective actionsMedical Governance Monitoring & ReportingSupport the development of reporting capabilities, including an understanding of what metrics R& D Quality possesses, or can develop, that reflect the needs of Medical Governance & Affiliates operationsProactively identify trends influencing Gilead’s overall compliance and propose monitoring and auditing tactics to further assess and evaluate trendsSupport monitoring and routine/ad hoc analysis and reportingAssist in providing day-to-day guidance, support and problem solving to internal stakeholders regarding monitoring and training issuesOversee monitoring, tracking, reporting, and communications to ensure compliance with required trainingCross-functional PartnerSupport strategic partnerships with our cross functional stakeholders including Medical Affairs, Global Medical Strategy and Operations, Affiliates, Legal, Ethics &Compliance, and R&D QualityWork collaboratively with other functional groups and relevant stakeholders, e.g., Regulatory Affairs and Patient Safety to advance the Medical Governance and Affiliate role as a Quality Business PartnerSupport the gathering of information necessary to escalate an issue of critical importance or controversy to the appropriate levelsMedical Governance and Affiliates Compliance CultureDevelop trusted relationships with Medical Affairs associates and Affiliate partners at all levels to promote an accountable complaint cultureAssure completeness and currency of documentation that describe policy and process practices across Medical Affairs activities and AffiliatesPromote a culture of quality, compliance and patient centricity **Only those lawfully authorized to work in the designated country associated with the position will be considered.** **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.** Benefits: For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website. California Pay Equity: For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here. Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances. If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department. Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).
About the Company
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Rose International
Founded in 1993 by Sue Bhatia, Rose International is one of the nation's leading minority- and woman-owned providers of Staffing and Total Talent Solutions. We serve companies in all 50 states and employ thousands of people across the country.