Vaishali Jain
@vaishalijain1
Experienced pharmaceutical professional specializing in clinical and scientific writing, regulatory affairs, and quality assurance.
IndiaWhat I'm looking for
I am a pharmaceutical professional with nearly six years of industry experience across scientific/medical writing, regulatory affairs, and quality assurance, focused on clinical trial documentation and dossier submissions.
At Springer Nature Technology and Publishing Solutions I created and maintained internal clinical trial documents for AdisInsight, authored clinical trial profiles and evidence updates, and received multiple star awards for timely, high-quality delivery.
I have prior experience in regulatory submissions and QA for oral solid dosage manufacturing and pharma packaging, handling eCTD documentation, CAPA, SOPs, audits, and cGMP compliance, and I hold an M.Pharm with strong academic distinctions.
Experience
Work history, roles, and key accomplishments
Scientific Medical Writer
Springer Nature Technology and Publishing Solutions
Created and maintained internal clinical trial documents for the AdisInsight database, authored trial profiles and evidence summaries, and resolved cross-team queries while earning multiple performance awards for timely delivery.
CIRegulatory Affairs Associate
Cipla
Handled regulatory submissions and dossier compilation for oral solid dosage products to regulated markets (US, EU, Canada, UK, Australia, ROW), coordinated with corporate RA and responded to regulatory queries.
Quality Assurance Executive
Shriji Polymers India Ltd.
Managed market complaints and CAPA, maintained quality documentation (SOPs, STPs, Site Master File), tracked audit compliances and ensured cGMP adherence on the shop floor.
Education
Degrees, certifications, and relevant coursework
Unknown (Certification in Advanced Program in Clinical Research and Management)
Certification, Clinical Research and Management
Completed a certification in Advanced Program in Clinical Research and Management in 2018.
S.G.S.I.T.S, Indore
Master of Pharmacy, Industrial Pharmacy
Grade: 7.81 SGPA
Activities and societies: Presented paper at national level; poster at Indian Pharmaceutical Congress; student delegate in clinical research seminar.
Completed M.Pharm. (Industrial Pharmacy) with honors and SGPA 7.81 from S.G.S.I.T.S, Indore in 2015.
M.I.P.S, Ujjain
Bachelor of Pharmacy, Pharmacy
2008 - 2012
Grade: 78.6%
Activities and societies: Student council president (2012) and cultural secretary (2011); won college cultural and sports events.
Completed B.Pharm. (Honors) with 78.6% and secured first position in the institute for the 2008–2012 batch.
Madhya Pradesh Board (HSC)
Higher Secondary Certificate, Science
Grade: 86.7%
Activities and societies: Placed 6th in divisional merit list and awarded a gold medal by Vaishnav Sahayak Trust, Indore.
Completed Higher Secondary Certificate from M.P. Board with 86.7% in 2008.
Madhya Pradesh Board (SSC)
Secondary School Certificate, General Education
Grade: 84.0%
Completed Secondary School Certificate from M.P. Board with 84.0% in 2006.
Availability
Location
IndiaAuthorized to work in
Job categories
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