Medical Writer Resume Sample

Medical Writer Resume Sample

Ravi Kumar
Email: XXX@gmail.com
Phone: +91-XXXXXXXXXX
Address: Co-operative society, Baner, Pune
Objective
To secure a challenging and responsible position in an organization where there is a scope of contributing and updating my knowledge and skills for the development of self and organization
Professional Summary
  • Experienced Medical Writer specialized in regulatory writing, scientific writing, medical communications and medical affairs in key therapeutic areas.
  • Have good knowledge on documentation of drug information queries, adverse drug reactions and drug-drug interactions.
  • Non-clinical and clinical documents/reports, regulatory documents/reports, scientific reports, manuscripts and medical communication material.
  • Have good knowledge in the area of Clinical Research for development of Protocols, Amendments and ICF’s.
  • Have knowledge on Pharmacovigilance activities.
  • Involved in pharmacist interventions, discharge medication interviews and Drug information services.
  • Have knowledge on ICH-GCP, MedDRA coding, Risk Management, Narrative Writing, CRF Designing, Schedule Y, Regulatory Writing, Scientific Writing, Query Management.
Professional Experience
Working as iOS Developer for ABC Ltd, Mumbai, since 2016

Responsibilities

  • Preparation of clinical study reports, protocols and patient narratives as per different client’s templates.
  • Collecting, compiling and analyzing the product related information such as product description, active ingredient, clinical trial details, therapeutic utility, pharmacological details and document as required by client.
  • Analyzing and interpreting the data medically and scientifically.
  • Framing the response for medical information queries requested by the health care professionals, product physicians and patients.
  • Preparation of clinical evaluation reports of medical devices and preparation of template and SOP of CER according to MEDDEV 2.7.1 Revision 4 guidelines.
  • Preparation of various manuscripts and scientific response documents for various therapeutic products.
  • Updations regarding regulatory clinical pharmacology requests and interaction queries.
  • Preparation of reports based on literature search of databases such as Medline, Embase, Ovid, Science direct, Cochrane Library, Medical journals, and other proprietary databases; analyze research publications, latest updates, clinical trials, science conference publications.
  • Preparation of adhoc requests when requested which need exhaustive literature search, analytical and interpretation skills.
Training certificate
Certification in “Advance Program in Clinical Research & Management” which include Clinical Trials, Clinical Data Management, Pharmacovigilance and Medical writing
Academic Details
  • Pharm-D from ABC College, Pune University in 20XX (secured 76%)
  • 12th from Saharanpur Public School , Saharanpur (UP) in 20XX (secured 78%)
  • 10th from Saharanpur Public School, Saharanpur (UP) in 20XX (secured 75%)
Personal Details
Date of Birth: XX/ XX/ XXXX
Marital Status: Unmarried
Languages Known: English, Hindi and XXXX
Address: XXXXX
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