Medical Writer Resume Sample

Medical Writer Resume Sample

Email: XXX@gmail.com
Phone: +91-XXXXXXXXXX
Address: Co-operative society, Baner, Pune 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

• 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.

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.

Certification in “Advance Program in Clinical Research & Management” which include Clinical Trials, Clinical Data Management, Pharmacovigilance and Medical writing

• 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%)

Date of Birth: XX/ XX/ XXXX
Marital Status: Unmarried
Languages Known: English, Hindi and XXXX
Address: XXXXX