Amol Agrawal Email & Phone Number

Hyderabad, In

Hyderabad, Telangana, India

Toronto, Ontario, Canada

Lead role in the development of publishing processes & documentation, including user acceptance testing for new & updated publishing tools.Delegation of these project activities to publishers within the department as needed.Subject matter expert for specific functions or processes, interacting & mentoring both within the department & with external stakeholders.Evaluate activities & business processes, identify areas in need of improvement & take the lead in investigating potential… Show more Lead role in the development of publishing processes & documentation, including user acceptance testing for new & updated publishing tools.Delegation of these project activities to publishers within the department as needed.Subject matter expert for specific functions or processes, interacting & mentoring both within the department & with external stakeholders.Evaluate activities & business processes, identify areas in need of improvement & take the lead in investigating potential solutions or new ways of working.Effective time management & organizational skills to efficiently manage multiple time-sensitive assignments simultaneously demonstrates a deep understanding of the business value of quality & compliance, & the implications & risks of non-compliance.Adjusts behaviours to drive high quality deliverable.Onboarding & Offboarding Process, Team management, Cross functional Team Coordination, Leadership, Time Management, Dashboard Metrics, Quality work Metrics Report, Work Management. Show less

Hyderabad, Telangana, India

Lead role in the development of publishing processes & documentation, including user acceptance testing for new & updated publishing tools.Delegation of these project activities to publishers within the department as needed.Subject matter expert for specific functions or processes, interacting & mentoring both within the department & with external stakeholders.Evaluate activities & business processes, identify areas in need of improvement & take the lead in investigating potential… Show more Lead role in the development of publishing processes & documentation, including user acceptance testing for new & updated publishing tools.Delegation of these project activities to publishers within the department as needed.Subject matter expert for specific functions or processes, interacting & mentoring both within the department & with external stakeholders.Evaluate activities & business processes, identify areas in need of improvement & take the lead in investigating potential solutions or new ways of working.Effective time management & organizational skills to efficiently manage multiple time-sensitive assignments simultaneously demonstrates a deep understanding of the business value of quality & compliance, & the implications & risks of non-compliance.Adjusts behaviours to drive high quality deliverable.Onboarding & Offboarding Process, Team management, Cross functional Team Coordination, Leadership, Time Management, Dashboard Metrics, Quality work Metrics Report, Work Management. Show less

Hyderabad, Telangana, India

As an integral member of regulatory operations team, provides regulatory publishing and submission support. Responsible for preparation, submission, tracking, and archival of paper and electronic submissions.Establishes and builds collaborative relationships with colleagues. Act as a liaison while coordinating regulatory publishing activities with other multidisciplinary teams. Provide expertise on regulatory publishing and authoring activities… Show more As an integral member of regulatory operations team, provides regulatory publishing and submission support. Responsible for preparation, submission, tracking, and archival of paper and electronic submissions.Establishes and builds collaborative relationships with colleagues. Act as a liaison while coordinating regulatory publishing activities with other multidisciplinary teams. Provide expertise on regulatory publishing and authoring activities. Collaborate with and manage publishing resources, when required. Show less

Hyderabad, Telangana, India

Produce regulatory publishing deliverables (e.g., INDs, NDAs, NDSs, MAAs, annual reports, routine submissions, Clinical Study Reports) in accordance with US and global requirements, using electronic publishing tools, and an EDMS system. Ensures assigned submissions are made with quality and on-time. Delivers of electronic regulatory submissions while ensuring that processes are followed, as well as quality and timelines are met in accordance with health authority requirements… Show more Produce regulatory publishing deliverables (e.g., INDs, NDAs, NDSs, MAAs, annual reports, routine submissions, Clinical Study Reports) in accordance with US and global requirements, using electronic publishing tools, and an EDMS system. Ensures assigned submissions are made with quality and on-time. Delivers of electronic regulatory submissions while ensuring that processes are followed, as well as quality and timelines are met in accordance with health authority requirements. Assists with development of assigned regulatory operations work instructions. Responsible for organizing and maintaining regulatory files. Provides regulatory publishing support to other departments.Responsible for completing Bookmarking, Hyperlinking and making documents ready for eCTD or NeeS submissions. Performed report-level publishing activities and quality control checks to ensure high quality submissions. Perform independent publishing QC on published output, complete appropriate checklists and/or provide assessments for the activities around the quality of report-level publishing and submission readiness of source documents for submission-level publishing. Stay abreast with updates for regulatory and/or industry standards. Show less

Ghansaur, Madhya Pradesh, India

Retail Pharmacy Operations.Drug Utilization Review.Final Quality Assurance Checks.Inventory Control & Patient Counseling.Pharmacy Marketing and Promotions.Manage ancillary staff in fulfilling more than 1,500 prescriptions weekly. Consult with physicians and patients with regard to medication dosage, drug interactions, medical equipment, disease management and potential side effects of prescription and OTC medications.Dispense and compound… Show more Retail Pharmacy Operations.Drug Utilization Review.Final Quality Assurance Checks.Inventory Control & Patient Counseling.Pharmacy Marketing and Promotions.Manage ancillary staff in fulfilling more than 1,500 prescriptions weekly. Consult with physicians and patients with regard to medication dosage, drug interactions, medical equipment, disease management and potential side effects of prescription and OTC medications.Dispense and compound prescriptions, and maintain accurate patient records, dosing information and directions for use. Show less

Mumbai, Maharashtra, India

Publishing activities includes Paper publishing, NeeS publishing, eCTD publishing for various types of submission which includes NDA, IND, PSUR, Annual Reports etc.eCTD submission includes Life Cycle Management of Various product's to USFDA , paper submissions to ROW market, NeeS and eCTD publishing submissions for Europe Regions.Performe dispatching submissions to HA Gateways ESG for US, EMA for EU.Archiving the submission in database.Performing submission level… Show more Publishing activities includes Paper publishing, NeeS publishing, eCTD publishing for various types of submission which includes NDA, IND, PSUR, Annual Reports etc.eCTD submission includes Life Cycle Management of Various product's to USFDA , paper submissions to ROW market, NeeS and eCTD publishing submissions for Europe Regions.Performe dispatching submissions to HA Gateways ESG for US, EMA for EU.Archiving the submission in database.Performing submission level QC.Computer based trainings and exercise practice conducted by client.Perform document level and final quality control reviews of submission PDF files.PSUR/DSUR/Annual report/IND safety report/Ad promo. Show less

Master Of Business Administration - Mba, Operational Management

Diploma In Business Management

Master Of Pharmacy, Pharmacy, 8.43

Bachelor Of Pharmacy - Bpharm, Pharmacy

Diploma In Computer Application

Education record