Experience

Lotus Labs Pvt Ltd

• India
• Research Services
• 100 - 200 Employee

• Dy. Manager: Medical Writing-Protocol

  • Aug 2014 - Present

   Prioritization and allotment of projects to the team. Assigning study numbers and corresponding with the sponsors for Protocols, ICD and CRF inputs. Review of BA/BE PK end point and clinical end point Medical Writing deliverables, including Clinical Study Protocols, Informed Consent Document (ICD) and Case Record Forms. Ensuring timely submission of the Protocols, ICDs, CRFs and study related appendices to Ethics committee. Participate in the Project status meeting.  Provide the Protocol status update to the management on regular basis. Co-ordinate with the Clinician, Bio-analytical scientists, Biostatistics team and Project management group for Sponsor inputs. Participate in technical discussions with internal teams and external stake holders like Sponsors, auditors and regulators as Pharmacokinetic expert on matters involving study designs, conduct and data evaluations and reporting.  Support Biostatistics and PK team to provide technical assistance on data analysis and reporting using Phoenix Winnonlin 6.1.3 and respond to Sponsor and regulatory queries related to Study design, washout, and carry over effect, PK parameter comparison with the published data and other regulatory queries involving Clinical and Bionalytical queries and deficiencies. Responding to PK and clinical end point Feasibility study synopsis to provide technical details about the study execution, required timelines, sample size, recruitment period and costing involved. Review various scientific literature for information on drug or other reference articles using internet search engines and compilation of data for preparation of Clinical Overview (CO) and Non Clinical Overview (NCO). Expertise in Literature search including Clinical and Non- clinical data for all therapeutic drug molecules for all regulatory bodies. Tracking metrics for capturing quality, productivity and resource utilization of the team. Drafting/ review of relevant standard operating procedures.

• Group Leader - Pharmacokinetics unit

  • Feb 2006 - Jul 2014

   Responsible for overall functioning of Pharmacokinetic subunit. Planning of activities, assigning and timely completion of assigned Projects. Periodic evaluation of existing systems and up gradation of the same in meeting changing business and regulatory requirements. Responsible for determining the study design, study planning, determination of sample size, and pharmacokinetics data analysis.  Training of department personnel for assuring uniformity in their task execution and maintaining quality within the department, including training on relevant technical aspects of Clinical study designs for evaluation of drugs, Pharmacokinetic Data analysis using Pharsight® WinNonlin 5.0.3 or Phoenix® WinNonlin 6.1.3 software and applicable SOPs.  Peer review and interpretation of study results to provide inputs on the product development. Review of literatures/ Sponsor data/ in-house study data to provide inputs for protocols and clinical study reports, study planning and sample size estimation for BA/BE/Clinical studies.  To provide response to sponsor & regulatory queries and inputs to study feasibility requests. Preparation and review of scientific / pharmacokinetic discussions for Swiss medic checklists and CS-BE Review and inputs to Protocols, Clinical study reports, Pharmacokinetics discussions aimed at regulatory submissions.  Leading protocol and Data review meetings and review of PK Concentration data for final data evaluation. Providing inputs on the study designs and inputs on the study protocol- determination of sample size, and data analysis for BA/BE and Phase I to Phase III PK studies Peer review of all the Concentration tables & PK metrics listings, graphs and validation of derived data sets performed by the team.  Proactively notify client on any issue which may delay the submissions of deliverables and consistently follow-up for timely resolution of issues.



Aurobindo Pharma Limited Research Centre, Hyderabad

• Research Associate II

  • Apr 2004 - Feb 2006

   Literature review, Preparation of Study Protocols and ICDs (BA/BE) in coordination with Sponsor, Project Co-coordinator, Principal and Clinical investigators, Biostatistician and panel of consultants intended at filing to various regulatory bodies. Writing Investigator brochures, Clinical Study Reports for BA/ BE and Phase I to phase III trials, including full study reports, abbreviated reports. Planning of Pharmacokinetic Blood sampling and sample size estimations Pharmacokinetic analysis of Concentration data using Pharsight® WinNonlin 5.0.3 Generating Randomization using SAS Preparation of Pharmacokinetic reports and listings Tables and graphical representation of data.  Responding to regulatory queries Submissions of Study protocols to IRB and management of IRB records. Evaluation of Study data, interpretation and inputs on formulation development. Preparation and review of clinical end point summaries.



AstraZeneca

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Executive –Quality control

  • Jan 2001 - Feb 2002

  Testing of Raw materials, Bulk drugs and finished products using instruments like UV-Visible Spectrophotometer, FTIR, HPLC, Karl-Fischer titrator, automatic potentiometric titrator and Gas Chromatography. Testing of Raw materials, Bulk drugs and finished products using instruments like UV-Visible Spectrophotometer, FTIR, HPLC, Karl-Fischer titrator, automatic potentiometric titrator and Gas Chromatography.