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Medical Writer

3-5 years
Not Disclosed
10 Feb. 10, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

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

  • Overall management and co-ordination of MW activities performed by the MW department.
  • Interact cross-functionally with other departments (e.g. Clinical Operations, Medical Affairs, QA, PM) to ensure the timely completion of high quality deliverables.
  • Ensure that all work done by the MW department is conducted in compliance with Advity.
  • Research Policies, SOPs and relevant guidance’s and guidelines.
  • Write and review protocols, ICFs and Clinical study reports for Phase I-IV studies (e.g. PK, FIM, BE/BA, safety), as needed.
  • 5Set up and monitor assigned project timelines by maintaining department scheduling tools.
  • Represent Advity in discussions with sponsors, at conferences and client meetings.
  • Work with the Quality Assurance group in the development/revision and implementation of
  • Standard Operating Procedures as required.
  • Acquire and maintain knowledge of national and international guidelines.
  • Participate in training sessions.
  • Work in a safe manner that does not endanger yourself of co-workers.
  • Execute other duties as may be required by management of Advity as training and experience allow