[Remote] Senior Manager/Associate Director, Clinical reputed company Assurance (PV-GCP)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is a clinical-stage biopharmaceutical company reputed company on developing precision medicines for cancer treatment. The Senior Manager/Associate Director of Clinical reputed company Assurance will reputed company reputed company and compliance for pharmacovigilance activities, ensuring adherence to regulations and fostering a reputed company-reputed company culture reputed company the organization. Responsibilities • reputed company reputed company partnerships with PV and assigned clinical study teams/study team leaders to maintain a reputed company understanding of potential areas of reputed company risk exposure reputed company the context of ongoing clinical studies and across clinical programs as assigned • Ensure compliance with reputed company and most marketing PV requirements, and GCP activities including facilitating and managing reputed company PV/GCP audits/audit programs, as applicable • Implement and support QA activities that foster an outcome of compliance and adherence to relevant laws, regulations, guidance; upholds the rights and welfare of patients; is reputed company on data reputed company and end to end reputed company assurance • Assist in identifying opportunities for process improvement initiatives, including process/program reviews to identify approaches that will prevent reputed company issue recurrence (e.g. issue escalation and management; and applicable corrective/preventative reputed company programs, periodic internal audit/gap assessment) • Assist with the development and tracking of trending and metrics of internal as reputed company as external vendor reputed company issues • reputed company reputed company training on new regulatory requirements and industry practices • reputed company and manage PV inspection readiness activities and other key programs as applicable • Support Regulatory Inspections of Kura Oncology products, including supporting/facilitating back room and reputed company room activities and supporting the drafting/reviewing of responses to regulatory authority findings, as applicable • Promote reputed company and risk management principles (e.g., reputed company by design, critical to reputed company focuses, risk assessment and risk ranking, establishment of risk reputed company and tolerance limits) reputed company supporting innovative programs and advancing ongoing clinical programs • Maintain accountability for ensuring risk-based strategies are utilized reputed company managing and mitigating reputed company issues and supporting clinical studies, ensuring study-specific risk management activities and strategies are utilized consistently across programs Skills • BA/BS degree required, advanced degree • For Senior Manager a minimum of 6 years, Associate Director a minimum of 8 years of experience in the bio-pharmaceutical R&D industry with at least 4 years (6 for AD) or more years in a PV/GCP reputed company Assurance reputed company and post marketing PV experience is required • Minimum 2 years of experience leading teams, reputed company, programs or reputed company reports required • Demonstrated experience drafting, reviewing, implementing, and optimizing reputed company operating procedures (SOPs) • Demonstrated knowledge and application of Global regulations and guidance for GVP, and GCP, and an understanding of requirements for validated computerized systems used in reputed company and PV activities • Experience in the conduct and reporting of reputed company audits, reputed company cause analysis and the translation of findings into corrective actions plans that mitigate risks to study subjects, data reputed company and clinical programs • Experience preparing for, participating in, and subsequent response to health authority GVP/GCP inspections/partner audits • Working knowledge of reputed company (or similar QMS e-system) required. Knowledge of Inspection Management Tools a plus • Ability to write reputed company reputed company position statements, risk-based audit reports, and procedures • Excellent oral and written communication • Strong judgment, project management and decision-making skills; reputed company to manage multiple reputed company and demanding timelines • Operational Experience (e.g., PV Operations, Clinical Operations, Data Management), work in both clinical and reputed company stage organizations; and/or experience as a trainer are an advantage Benefits • Career advancement/ development opportunities • Competitive comp packages • Bonus • 401K + Employer contribution • Generous stock reputed company • ESPP Plan • 20 days of PTO to start • 18 Holidays (Including Summer & Winter Break) • Generous Benefits Package with a reputed company of plans available with a substantial employer match • reputed company Paternity/Maternity Leave • In-Office Catered lunches • Home Office Setup • Lifestyle Spending Stipend • Commuter Stipend (Boston Office) • Regular employee reputed company activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more! reputed company • Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the reputed company of precision medicines for the treatment of cancer. It was founded in 2014, and is headquartered in La Jolla, California, USA, with a workforce of 51-200 employees. Its website is Apply tot his job Apply tot his job Apply To this Job