Siddhi Shivkumar
MEDICO MARKETING | CER Writer | J&J | TRAUMA & EXTREMITIES | SPINE | MDD | MDR | CLINICAL EVALUATION REPORT | CEP | SSCP | MEDICAL WRITER | LITERATURE SEARCH | LITERATURE REVIEW | MEDICAL DEVICES
- Role
- Senior Technical Lead at HCLTech
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Siddhi Shivkumar
CER writer for high risk medical devices and for medical devices transitioning to MDR…
Experience
Senior Technical Lead
Feb 2021 — Present · Bengaluru, IN
Providing medical writing services to J&J for Trauma & Extremities and Spine portfolios. Direct client facing. CER Writer, Medical devices, MDR uplifts, Regulatory writing
Education
Bombay College of Pharmacy Kalina Santacruz (E) Mumbai - 400 098
Associate's degree
Bombay College of Pharmacy
Post Graduate Diploma in Clinical Research
2011 — 2012
Ramnarain Ruia College, Mumbai University
Master of Science (M.Sc.)
2008 — 2010
Bombay College of Pharmacy
Post Graduate Diploma in Pharmacovigilance
2012 — 2013
Alliance française
French Language (A1)
2016 — 2016
K.J. Somaiya College, Mumbai University
Bachelor of Science (B.Sc.)
2006 — 2008
VLCC Institute
Certificate course in Clinical Nutrition
2010 — 2010
Skills
- Pharmacovigilance
- Ich-Gcp
- Clinical Development
- Ctms
- Clinical Trials
- Medical Devices
- Clinical Research
- Gcp
- Medical Writing
- Clinical Data Management
- Life Sciences
- CRO
- Clinical Monitoring
- Regulatory Affairs
- Lifesciences
- Regulatory Submissions
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