GOURAV SONI
Medical Affairs Project And Content Manager
Pune,Maharashtra
Summary
9.5 Years of rich professional experience in the Project Management & Content Management (2.3 Years) quality assurance (4.5 years), scientific writing and regulatory affairs (2.5 Years) of various reputed pharmaceutical companies.
Worked on different regional projects as per regional requirement for development and commercial activities in product lunch.
My expertise revolves around Audit faced USFDA Regulations, U/L Regulations, NSF Regulations, ISO Regulations, WHO Regulations.
Experience in handling different applications like PowerBi, Microsoft SharePoint, Smartsheet, Microsoft Forms, Monday.com, Amazon workspace, TRU, Symphony ETQ, RMQ, RM basis.
Thorough experience in Quality Management System (QMS), Quality Operations, Quality Control, Investigations and Validation, Documentation, Training, Equipment Qualification, SOP, BPR & BMR review, Regulatory, Compliance and CQA.
Expertise in Project Management, Content Management, Data Management, Medical Writing, Regulatory Affairs, Clinical Project Management, Regulatory Writing, and Process Improvement.
Overview
10
10
years of professional experience
12
12
years of post-secondary education
1
1
Certification
1
1
Language
Work History
Medical Affairs Project & Content Manager
Department: Medical Excellence & Operations
5 2022 - Current
- Handling medical affairs projects Clinical Trials, ESG (Environmental Social Governance), Advisory Board, IIT, Clinical Trials, Medical Information, MSL, MSH efficiency Tachometer, and Scientific communication
- Preparation, implementation, follow-up medical affairs timelines by different project management tools Smart sheet, Monday.com, Planisware
- Working in medical affairs project core team to work for medical affairs project with different vendors
- Working experience with global team and affiliates for handling project management task and activity
- Handling following up and supervision of clinical trials project management activity
- Creation for PowerBi graphs and report for medical affairs Project and metrics
- Handling and building Microsoft SharePoint for GBU and stakeholders for storing medical affairs scientific materials and content
- Handling medical affairs scientific material and content process flow in Veeva Promomats
- Handling and managing global user access for different application PowerBi, Microsoft SharePoint
- Creating Microsoft forms for project management queries
- Working experience with different vendors on new medical affairs projects
- Handling clinical trials tracking applications for expenditures and timelines calculation (Planisware)
- Handling new medical affairs new project requirement for implementation of new tool
- Initiate, implementation and follow-up with GBU heads, regional heads, and country affiliates on medical affairs projects
- Collection of yearly, half yearly, quarterly, and monthly KPI like ESG (Environmental Social Governance), Advisory Board, IIT, Clinical Trials, Medical Information, MSL, MSH efficiency Tachometer, Scientific communication
- Providing training to global and affiliates on different medical affairs projects
- Hand on experience for creating global power point slides for project requirement
- Hand on experience for development Microsoft forms and Microsoft SharePoint pages
- Hand on experience for creation business case proposal for medical affairs project
- Hand on experience in PowerBi report creation and Microsoft SharePoint creation.
Senior safety science specialist
Department: Scientific Writing & Regulatory Affairs
06.2018 - 12.2020
- The prime focus of work experience is linked with the development of project management skills and collaboration with stakeholders
- Understanding new product development and lifecycle management for importation project for J&J Product Launch in Asia pacific, North America, Latin America, and Europe
- To manage internal and external client meetings
- Support in commercializing of new product and qualification of raw materials under hair care, personal care, cosmetic products and Understanding market strategy for extended raw material to be utilized in North America LATAM APAC and EMEA Region
- Reinforcing export and import of raw materials for the development of the product
- Create and manage global change control (GCC) for these revisions to the raw material specifications
- Coordinate and interact with various internal departments like Procurement, Analytical, Technical Assurance and External manufacturers/sites, Suppliers and Distributors to understand the change, impact assessment, implementation strategy and required documentation governing the change
- Creation and implementation of flowchart under CTQ approach for specification update in TRU
- Involvement in weekly team meetings
- Creation/ Evaluation of proposed specification table for Rubicon cross qualification GCC’s and for Rubicon projects
- Implement use of consistent, efficient, and quality process to meet timelines and deliverables according to regulatory requirement
- Assist in preparation of Regulatory Affairs Work Instructions for Covance scientific solutions Pvt
- Ltd
- And coordinate and interact with clients to discuss and provide solutions to regulatory issues, supplier notification changes, analytical changes
- Handled training for new joiners to create and update the development specification and commercial specification
- Handled Peer review and QC checks for specifications and GCCs
- Ensure compliance of operations with governing regulatory requirements.
QA Officer
Department: Quality Assurance
02.2017 - 06.2018
- Handled Quality Management systems (QMS) - Monthly KPIs, Review and Handling of Deviations Investigations, Change controls, CAPA, Laboratory Investigation report
- Involved in self-inspection activities
- Handled Vendor Qualification relevant activities & updating relevant List
- Handled issuance and retrievals of QMS Documents – Deviation, change control, CAPA, Laboratory Investigation, formats, and logbook etc
- Handled Regulatory Submission, Internal, External and consultant’s audits and involvement in compliance response
- Involved Follow up activities in Audit compliance
- Involved in Trackwise activities for deviation implementation
- Prepared distributed & Executed SOP’s
- Handled Issuance and submission of audit documents
- Handled and Managed QMS document
QA Officer
Department: Quality Assurance
12.2015 - 01.2017
- Performing In-process quality assurance checks during Dispensing, Manufacturing & Packaging Line clearance at every step of batch manufacturing
- Maintaining and updating the batch manufacturing records
- Sampling of Batches during manufacturing & packaging Stages
- Verification of logbooks, calibration records, temperature, and humidity records etc
- Issuance & destruction of documents (SOP formats)
- Calibration of instrument & equipment’s like Moisture Analyzer, Seal Check apparatus, Analytical weighing balance calibration
- Revision retrieves of BMR, BPR
- Perform AQL activities for finish goods
- Validation activities
- APQR Handling Handling of Deviation
- Monitoring and handling dispatch activities for finish goods
- Handled data container data logger activities.
QA Chemist
Department: Quality Assurance
01.2014 - 11.2015
- Documentation of logbooks, calibration records, temperature, and humidity records etc
- Issuance & destruction of documents (SOP’s, change control, deviation, CAPA)
- Issuance of BMR’s & BPR’s
- Handled issuance of raw materials and API materials
- Calibration and validation of equipment, instruments
- Issuing of line clearance at every step of batch manufacturing
- Maintaining and updating the batch manufacturing Records
- Sampling of Batches during manufacturing & packaging Stages
- Sampling for Bioburden, Stability Studies of Batches, Hold time sampling
- Performing In-process quality assurance checks during Dispensing, Manufacturing & Packaging of Parenteral Formulation
- Verification of finished in packaging area
- Handled labeling activities of Production areas.
Education
LL.B - Law (Pre-Law)
Indore Institute of Law
Indore 08.2020 - 05.2023
M. Pharmacy - Quality Assurance
KLE University's College of Pharmacy
Belgaum, Karnataka 08.2011 - 07.2013
B. Pharmacy - Pharmacy
Oriental College of Pharmacy
Bhopal, Madhya Pradesh 08.2004 - 12.2009
HSSC - PCB
Saraswati Vidya Mandir Hr. Sec. School
Bhopal, Madhya Pradesh 06.2003 - 06.2004
HSC - Basic
Saraswati Vidya Mandir Hr. Sec. School
Bhopal, Madhya Pradesh 06.2001 - 06.2002
Skills
Medical Affairs Project Management
Awards Recognition Training
- Client appreciation award was received for outstanding support in the month Aug 2019, July 2019, May 2019 and in Feb 2020 in Covance scientific solutions Pvt. Ltd
- Spot award was received in Emcure Pharmaceutical Ltd in June 2017
Certification
Completed PowerBi certification from Intellipath in May 2024
Software Application Handled
- PowerBi
- Microsoft SharePoint
- Veeva Med coms
- Veeva Promomats
- Microsoft Project
- Microsoft Forms
- Microsoft SharePoint
- Amazon workspace Symphony
- ETQ
- RMQ
- TRU
- LIMS
- PATH
Personal Qualifications
Ambition
Flexibility
Honesty
Initiative
Good Listening and Mind Mapping Global mindsetPersonal Information
Date of Birth: 01/28/87
Disclaimer
I hereby declare that all the statements made in above information are correct to the best of my knowledge and belief.
Timeline
Completed PowerBi certification from Intellipath in May 2024
05-2024
LL.B - Law (Pre-Law)
Indore Institute of Law
08.2020 - 05.2023
Senior safety science specialist
Department: Scientific Writing & Regulatory Affairs
06.2018 - 12.2020
QA Officer
Department: Quality Assurance
02.2017 - 06.2018
QA Officer
Department: Quality Assurance
12.2015 - 01.2017
QA Chemist
Department: Quality Assurance
01.2014 - 11.2015
M. Pharmacy - Quality Assurance
KLE University's College of Pharmacy
08.2011 - 07.2013
B. Pharmacy - Pharmacy
Oriental College of Pharmacy
08.2004 - 12.2009
HSSC - PCB
Saraswati Vidya Mandir Hr. Sec. School
06.2003 - 06.2004
HSC - Basic
Saraswati Vidya Mandir Hr. Sec. School
06.2001 - 06.2002
Medical Affairs Project & Content Manager
Department: Medical Excellence & Operations
5 2022 - Current
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