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2+ years
Not Disclosed
15 June 19, 2024
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, 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

Work Schedule

 

Environmental Conditions

 

Job Description

 

• Serves as primary author who writes and provides input on routine documents 
such as clinical study reports and study protocols, and summarizes data from 
clinical studies.
• Ensures compliance with quality processes and requirements for assigned 
documents. May assist in determining best practices, methods and techniques 
for achieving optimal results.
• May assist in program management activities. Duties could include assisting with 
developing timelines, budgets, forecasts for assigned deliverables. 
• Represents the department at project launch meetings, review meetings, and 
project team meetings.

 

Education and Experience:

Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational Qualification. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

 

Knowledge, Skills and Abilities:

• Solid medical writing skills, including grammatical, editorial, and proofreading skills

• Ability to interpret and present complex data accurately and concisely

• Effective administrative, organizational and planning skills; attention to detail and quality

• Ability to work on own initiative and effectively within a team

• Effective oral and written communication skills

• Good knowledge of regulatory documentation and drug development process