Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Medical Writer

Advity Research
ADVITY Research
3-5 years
upto 9 LPA
7 Aug. 7, 2024
Job Description
Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Medical Writer

Location: Hyderabad

Experience Required: 3 to 5 years

Employment Type: Full Time

Department: BA/BE & Clinical Trials

Qualification:

  • Graduate/Post Graduate/Doctorate degree in Life Sciences, Pharmacy, Medical Sciences, or equivalent degree.
  • Fluency in English.

Mode of Work: On premise

Job Description:

  • Management and Coordination: Overall management and coordination of MW (Medical Writing) activities performed by the MW department.
  • Cross-Functional Interaction: Interact cross-functionally with other departments (e.g., Clinical Operations, Medical Affairs, QA, PM) to ensure the timely completion of high-quality deliverables.
  • Compliance: Ensure that all work done by the MW department is conducted in compliance with Advity’s Research Policies, SOPs, and relevant guidelines.
  • Writing and Reviewing: Write and review protocols, ICFs, and clinical study reports for Phase I-IV studies (e.g., PK, FIM, BE/BA, safety), as needed.
  • Project Timelines: Set up and monitor assigned project timelines by maintaining department scheduling tools.
  • Representation: Represent Advity in discussions with sponsors, at conferences, and client meetings.
  • SOP Development: Work with the Quality Assurance group in the development, revision, and implementation of Standard Operating Procedures as required.
  • Guideline Knowledge: Acquire and maintain knowledge of national and international guidelines.
  • Training Participation: Participate in training sessions.
  • Safety: Work in a safe manner that does not endanger yourself or co-workers.
  • Additional Duties: Execute other duties as may be required by the management of Advity as training and experience allow.