Swapnil Marghade
Senior Medical Writer and Project Tracking
- Role
- Senior Medical Writer at Teva Pharmaceuticals
- Location
- Navi Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Swapnil Marghade
Total 14 years of experience in Clinical trial study report (CSR), protocol, informed…
Experience
Senior Medical Writer
Mar 2021 — Present · Navi Mumbai, IN
Authoring of clinical trial study report (CSR), protocol, informed consent form (ICF), compilation and preparation of CSR appendices (section 16). Preparation/review of clinical trial protocol, CSR, ICF, investigator’s brochure (IB). Review, edit and ensure quality of documents and adherence of standards Worked on therapeutic area such as oncology (Breast cancer) and dermatology. Experience of working with Veeva vault and GRIDS. Utilization of AI in medical writing. Basic medical coding using MedDRA and WHO drug dictionary Training to new report writers Basic project management skills including understanding of clinical timelines (study and submission level) Strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team. Preparation of module clinical summary, csbe, 2.7.1 (Europe, Canada, USFDA), addendum to the clinical overview (ACO)
Education
Nagpur University
XII
2001 — 2003
Lal bahadur High school, Bhandara
X
2000 — 2001
Nagpur University
Bachelor of Pharmacy (B.Pharm.)
2004 — 2008
Manipal Academy of Higher Education
M Pharm
2009 — 2011
Manipal Academy of Higher Education
Bachelor of Pharmacy - BPharm
NMIMS Global Access School for Continuing Education
PGDM
2015 — 2018
Skills
- Lc-Ms
- Hplc
- Preclinical.phase I,Ii,Ii,Iv Studies
- Method Development
- Chromatography
- Validation
- Regulatory Requirements
- Lims
- Regulatory Affairs
- Drug Development
- Bioanalysis
- Glp
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