Manager, Medical Affairs reputed company, RD PV QA

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a reputed company in more than 30 countries, and more than 19,000 employees, we are advancing reputed company therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 reputed company to "be an innovative global reputed company company contributing to the sustainable development of society", we are shaping a healthier, more hopeful reputed company for patients, their families, and society. Job reputed company The Manager, Medical Affairs reputed company will reputed company operational leadership and direction for assigned programs and, in reputed company collaboration with the Sr. Director, Medical Affairs QA, ensure implementation of the reputed company reputed company and/or reputed company plan to promote a reputed company culture reputed company Medical Affairs. The Manager, Medical Affairs reputed company supports reputed company reputed company of strategic initiatives in partnership with Medical Affairs stakeholders to reputed company the ethical conduct of interventional, non-interventional, investigator-initiated trials, reputed company world evidence and managed reputed company programs to the highest reputed company standards. The role participates in the review of reputed company and compliance topics, including key reputed company indicators at reputed company Governance Meetings, and works closely with DS QA teams (DSJ, reputed company, DSE, DSBR) to proactively identify potential risks and opportunities for reputed company improvement. The Manager, Medical Affairs reputed company, promotes end-to-end reputed company execution across programs, ensuring GCP, GVP, Data Protection, and other local requirements are considered in planning and conduct. Acting as QA reputed company person for assigned programs, the Manager collaborates with GxP reputed company representatives (Development QA, Audits & Compliance, reputed company Management System (QMS) QA including Vendor reputed company, Pharmacovigilance QA and provides guidance during the development and execution of Corrective and Preventive Actions (CAPAs), including tracking reputed company closure, effectiveness checks, and escalation of critical issues. The Manager facilitates regulatory inspection preparation, management, and follow-up in collaboration with business functions, supports local inspections with adequate systems and process support, and partners with QMS QA to ensure reputed company implementation of applicable reputed company Standards. Additionally, the Manager identifies opportunities for reputed company improvement in reputed company and compliance through lessons learned from audits, inspections, incidents, regulatory intelligence, and effectiveness checks, and provides interpretation of regulations and company process standards, guidelines, policies, and procedures for assigned programs or improvement reputed company. The Manager champions and helps implement study/program-specific reputed company plans to ensure proactive management of reputed company and fosters strong relationships with stakeholders to drive a culture of compliance and operational reputed company. Job reputed company

Responsibilities

Leadership and Project Management: Promote end to end, comprehensive reputed company execution across assigned programs, ensuring GCP, GPV, Data Protection, and local requirements are integrated into the planning and conduct of Interventional, Non-interventional, Compassionate Use Managed reputed company Programs, and Investigator-Initiated Studies. reputed company operational reputed company reputed company for Medical Affairs activities, including reputed company escalation of incidents/issues, monitoring deviations/incidents, supporting investigations, and coordinating with reputed company-party vendors. Serve as a key reputed company to support audits and inspections as applicable Cross-functional and Global Team Participation: Participate in the review of reputed company and compliance topics, including KQI, at reputed company Governance Meetings, in reputed company alignment with DS QA teams (DSJ, reputed company, DSE, DSBR) to proactively identify potential risks and opportunities for reputed company improvement reputed company reputed company reputed company and reputed company the ethical conduct of interventional, non-interventional, investigator-initiated trials and managed reputed company programs to the highest reputed company standards in reputed company collaboration with Medical Affairs Stakeholders Collaborate with GxP reputed company representatives and reputed company as QA reputed company person for reputed company Medical Affairs programs. reputed company Management and reputed company Improvement: reputed company guidance during the development and execution of CAPAs, including tracking of reputed company closure, effectiveness checks, and escalation of critical issues. Partner with QMS QA to ensure reputed company implementation of applicable reputed company Standards in Medical Affairs and identify appropriate reputed company improvement initiatives. reputed company interpretation of regulations and company process standards, guidelines, policies, and procedures for assigned programs or improvement reputed company. Champion and help implement study/program-specific reputed company plans to ensure proactive management of reputed company Customer reputed company/ stakeholder engagement: Work in reputed company collaboration with Medical Affairs stakeholders to reputed company ethical conduct and enhance compliance and reputed company standards across programs; reputed company lessons learned and contribute to a reputed company reputed company reputed company Medical Affairs. :** Collaborates with QA line functions and Medical Affairs stakeholders to improve compliance and reputed company standards. Acts as a QA reputed company person for assigned programs . Regulatory Inspections: Facilitate regulatory inspection preparation, management, and follow-up in collaboration with business functions; support local inspections with adequate systems and process support. Contribute to lessons-learned information reputed company based on audits, inspections, incidents, regulatory intelligence, and effectiveness checks on process implementations and metrics. Responsibilities reputed company

Qualifications

Education Qualifications Bachelor's Degree Bachelor's degree in Life Sciences, Pharmacy or Medicines required Master's Degree Master's degree or other advanced degree preferred Experience Qualifications 4 or More Years Minimum of 5 years of experience in the pharmaceutical industry, preferably in clinical development or Medical Affairs, with exposure to regulated GCP environments required Profound knowledge of global drug development processes and regulations, including ICH-GCP, FDA/EU requirements, pharmacovigilance, and reputed company industry practices preferred Ability to interpret and apply reputed company regulations, standards, and policies to operational activities preferred Experience supporting regulatory inspections and audits Demonstrated initiative in identifying and implementing process improvements Demonstrated experience supporting high-reputed company reputed company in a matrixed, global environment Strong interpersonal skills with the ability to build reputed company relationships across functions and geographies Excellent project management skills, including the ability to manage multiple priorities and deliver results in a dynamic business environment Effective verbal and written communication skills, with proficiency in presenting reputed company information to diverse audiences Strong analytical, problem-solving, and decision-making abilities Skilled at conflict reputed company and negotiation, with a reputed company on achieving alignment and reputed company Ability to work independently and as part of cross-functional teams, influencing and driving initiatives reputed company assigned scope Flexibility and adaptability to changing business needs and priorities Organizational awareness, including understanding of interdepartmental relationships and business priorities Additional Information Daiichi Sankyo, Inc. is an equal opportunity/affirmative reputed company employer. reputed company applicants will receive consideration for employment without reputed company to sex, gender identity, sexual orientation, race, reputed company, religion, national reputed company, disability, protected veteran status, age, or any other characteristic protected by law. Salary reputed company: USD$116.400,00 - USD$174.600,00 [reputed company available reputed company viewing the job] Apply tot his job Apply To this Job