Hiring for Clinical & Medical Operations Professional Hyderabad for Exp. 7 - 10 Years at Dr. Reddys Laboratories Ltd..
MedWiz Hyderabad, Telangana, India
Dec 30, 2018Full time
Job Description:Key Responsibilities: Supervise the clinical development operation (protocol finalisation, site selection) resolve complex issues w.r.t conduct of clinical and patient based pharmacokinetic studies & supervise medical monitoring activities in order to make sure that generation of quality data for product approval in different regulatory markets. Design Clinical development plans(synopsis) and translate into applicable study protocols in order to conduct active studies for different business regions for product approval. Work closely with the quality team in the conduct of quality audits of the studies in order to adhere to above-average clinical practice and regulatory requirements. Provide inputs on data management plan, quality output and robust bio-statistics framework with inputs on SAP (statistical assessment plan), design element of study, sample size and outcome assessment of results in order to gain successful outcome of clinical studies, well-rounded clinical study report for regulatory filing acceptance. Supervise the preparation of clinical study reports, review and approve the final study report for regulatory submission Present study results to regulatory authorities in order to seek marketing permission from the respective regulatory authorities & publishing of submitted data in reputed journals. Develop plans for enabling clinico-regulatory discussions with regulatory agencies in collaboration with the in-house Clinical Strategy & Regulatory teams in order to gain clinical waivers, positive opinion on innovative clinical approaches from well-steered scientific advice meetings. Manuscript preparation for publication in peer-reviewed journals, & presentations of abstracts/posters at national & international conferences/ congress. Conduct goal setting, performance appraisals, and coach employees, participate in recruitment, identify training needs of team members, conduct /initiate training programs (technical and behavioural) in order to guide the team in achieving its performance targets. Operating Network: Internal: Clinico- Regulatory Team, Product Development Team, Business Development Team, and Alliance Management. External: Regulatory Authorities, Trial Investigators, CROs, Hospitals, Ethics Committees Knowledge: Regulatory requirements (USFDA, EMEA, EMIN), ICH GCP, Understanding of drug development process.