Senior Medical Writer

View: 104

Update day: 06-05-2024

Location: Delhi Union Territories

Category: Pharmaceutical / Chemical / Biotech Health / Medical Care Pharmacist / Pharmaceutical representatives

Industry: Pharmaceutical & Life Sciences

Position: Clinical Research Associate/Scientist

Job type: Full Time, Permanent

Salary: ₹ 6,00,000 - 8,00,000 P.A.

Experience: 1 - 5 years

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Job content

Roles and Responsibilities

To Participate in the process of protocol design and medical writing and review as appropriate in coordination with clinical strategy, medical operations, and lab operations.
Manage the writing, editing, and reviewing of diverse regulatory & clinical documents including clinical study reports (CSRs), study protocols, investigator brochures, informed consent forms, clinical data summaries, and other medical/regulatory documents (including regulatory summary documents).
Provides input to timelines for completion of clinical documents, and ensuring delivery of documents to meet the timelines.
Develop, implement and manage templates & documentation format required for standardization of regulatory & clinical documentation to support development and registration activities.
Serve as the primary medical writing representative on assigned product teams and closely collaborate with personnel from clinical, regulatory, and scientific departments
Reviews pertinent literature, evaluating its applicability, and incorporating the information into clinical documents.
Ensures that all clinical documents are produced according to appropriate SOPs and
business practices
previous projects in diabetes/hypertension/chronic health and metabolic conditions

Desired Candidate Profile

1. 2-4 Yrs. of Experience in medical writing
Familiar with DCGI/FDA/EMEA requirements, good clinical practices, and pharmaceutical and biosimilar clinical development.
Good understanding of experimental methods, research design, regulatory knowledge, and statistical analysis
Ability to analyze medical data and interpret its significance within a pharmaceutical setting
Ability to interpret, analyze, and present statistical data obtained in a clinical trial
Advanced scientific/regulatory, technical reading, writing, and editing skills
Excellent oral communication and interpersonal skills
Projects/publications(preferred)/work experience in companies dealing in these

Location - Delhi

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