On hand experience of setting up a fully functional clinical research and bioequivalence department right from scratch and establishing systems and SOPs for the clinical research activities. Currently heading Clinical Research and regulatory function and responsible for business intelligence, project conceptualization, operation execution, quality assurance, data analysis, regulatory submissions, medical writing, publication writing etc. Besides this I am also responsible for resource… Show more On hand experience of setting up a fully functional clinical research and bioequivalence department right from scratch and establishing systems and SOPs for the clinical research activities. Currently heading Clinical Research and regulatory function and responsible for business intelligence, project conceptualization, operation execution, quality assurance, data analysis, regulatory submissions, medical writing, publication writing etc. Besides this I am also responsible for resource allocations, prioritizations and planning of projects, managing budgets and decision making based on regulatory guidance, scientific facts and figures.I am having senior level negotiation experience with CROs, central analytical / pathological laboratories, logistic services companies, translation bureaus, scientific research organizations, and premier academic research institutes in the country. I have a strong combination of scientific and entrepreneurial skills along with the knowledge of intellectual property management and commercialization of innovation, evaluation of technologies for commercial potential and patentability, proposal writing, business plan development, project management and technical consulting. Show less

 Worked on Ethics Committee- Design all the documents for their registration and approval. Worked on BA/BE Center Approval- Design all the documents for their registration and approval. Ensure structured communication plan and implementation by review meetings, preparing MOM. Co-ordination with internal team like FR&D, QA, RA, purchase etc. to understand the dossier development timelines. Effectively communicate project expectations to team members and stakeholders in a… Show more  Worked on Ethics Committee- Design all the documents for their registration and approval. Worked on BA/BE Center Approval- Design all the documents for their registration and approval. Ensure structured communication plan and implementation by review meetings, preparing MOM. Co-ordination with internal team like FR&D, QA, RA, purchase etc. to understand the dossier development timelines. Effectively communicate project expectations to team members and stakeholders in a timely and clear fashion. Assisting clinical sites with IRB/IEC submissions and ensuring collection of required essential documents for study start-up and throughout conduct of study. Maintaining awareness of local regulatory requirements, and to conduct studies in accordance with SOPs, guidelines and ICH Good Clinical Practice guidelines. Reviewing all data produced from each study and resolves any data queries/protocol deviations identified. Maintaining effective communication with other members of the clinical team and management. Maintaining site files, trial master files and study documentation; developing status reports, SOP revisions and document quality control.  Maintain records of all reviews, Develop and deliver progress reports, proposals, requirements documentation. Collecting, collating and evaluating scientific data that has been researched by colleagues. Developing and writing clear arguments and explanations for new product licences and licence renewals. Writing clear, accessible product labels and patient information leaflets. Advising scientists and manufacturers on regulatory requirements. Providing strategic advice to senior management throughout the development of a new product. Project managing teams of colleagues involved with the development of new products. Liaising with, and making presentations to, regulatory authorities. Specifying storage, labelling and packaging requirements. Show less

 Working with various Analytical Instruments like HPLC, HPTLC, FTIR, GC, UV/Visible Spectroscopy, Fluorimeter, Inverted microscope and Auto-titrator etc. Testing of various pharmacopoeial compounds (Industrial Samples).  Validation & calibration of instruments and SOP preparations.