Highly dedicated, compassionate medical writer with more than three years of experience with a proven track record of creating accurate, compliant and high-quality content, translating complex medical information into clear and concise language for a variety of audiences for healthcare industries. Seeking to leverage my expertise to contribute to a reputable healthcare organization and make a positive impact on patient care.
Hi, I’m
Mohan Haribhau Shitole
Pune
Summary
Overview
20
years of professional experience
1
Certification
Work History
Synergen Bio Pvt. Ltd.
Medical Writer
06.2021 - Current
Job overview
- Compiling, writing, and editing medical writing deliverables
- Developing or supporting various documents, including clinical study protocols, clinical study reports, patient narratives, and investigator brochures
- Reviewing statistical analysis plans and table/figure/listing specifications
- Collaborating with department heads and staff members across departments
- Adhering to regulatory standards, including ICH-E3 guidelines and company SOPs
- Conducting online clinical literature searches, as applicable
- Continuing professional development to stay updated with regulatory guidance
- Managing project budgets and timelines effectively
- Participate in feasibility and/or site identification activities
- Communicating with medical experts, patients, or representatives from pharmaceutical companies for medical resources and verifications
- Conducting frequent and thorough quality control checks on each submission
- Having professional knowledge of DSUR, PSUR
ICMR-NARI
Research Assistant
05.2019 - 04.2021
Job overview
- Company Overview: Pune
- Preparing IMP request for distribution and maintaining IMP accountability
- Prepared IP as per protocol and dispensed for patient administration; maintained IP record in double-blind study design
- Tracked and managed Case Report Forms (eCRFs), queries and clinical data flow
- Involved in SAE related Meetings with Sponsor and Principal investigator along with Clinical Operational and Medical Monitors
- Assist with the development of project specific training material for team
- Pune
PDEA's SU College of Pharmacy
Associate Professor
10.2010 - 04.2019
Job overview
- Taught undergraduate/graduate courses
- Mentored students in research projects and academic advising
- Served on departmental committees (e.g., curriculum development, faculty recruitment)
Nebumed Pvt Ltd (Cipla)
Quality Control Officer
08.2005 - 05.2007
Job overview
- Develop, implement, and maintain quality control procedures and standards
- Conduct regular analysis of raw materials, finished products to ensure compliance with quality standards
- Collaborate with production teams to resolve quality-related problems
- Analyze data to identify trends and areas for improvement
- Implement corrective actions to prevent quality issues
Education
NDMVP Gov. College of Pharmacy
Master of Pharmaceutical Chemistry
09.2010
University Overview
PDEA SGRS College of Pharmacy
Bachelor of Pharmacy
05.2005
University Overview
Skills
- Critical thinking
- Editing and proofreading
- Writing and communication
- Organizational and time management
- Adaptability and flexibility
- Continuous learning
- Attention to detail
- Literature search
- Collaborative problem solving
- Sound knowledge of ICHGCP
- Ethical standards
- Proofreading
- Content strategy
Certification
- GPAT (GATE (Graduate Pharmacy Aptitude Test), NTA (National Testing Agency), 02/01/20
- GATE (Graduate Aptitude Test in Engineering), Indian Institute of Technology Roorkee, 03/01/09
- GATE (Graduate Aptitude Test in Engineering), IISc (Indian Institute of Science, Bangalore), 02/01/08
Languages
English
Hindi
Marathi
Personal Information
Personal Information
- Date of Birth: 06/26/82
- Gender: Male
Work Structure
Work Structure
10/10, 10/10, 9/10Timeline
Medical Writer
Synergen Bio Pvt. Ltd.
06.2021 - Current
Research Assistant
ICMR-NARI
05.2019 - 04.2021
Associate Professor
PDEA's SU College of Pharmacy
10.2010 - 04.2019
Quality Control Officer
Nebumed Pvt Ltd (Cipla)
08.2005 - 05.2007
PDEA SGRS College of Pharmacy
Bachelor of Pharmacy
NDMVP Gov. College of Pharmacy
Master of Pharmaceutical Chemistry
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