Medical Writer
- Golden Opportunities
- 3 - 7 Years
- Chennai
- 3 years ago
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Job Description
job_descriptionJob Responsibilities and Skills:
- Authors a variety of regulatory documents such as clinical study reports (CSRs) investigator's brochures (IBs) Protocol and other regulatory documents.
- Projects will generally be assigned at the individual document level but may be assigned at the submission level as appropriate.
- Ensures appropriate and effective collaboration with key functional contributors and that all documents are authored according to regulatory requirements internal Company document standards and with adherence to timelines and team expectations.
- Cross functional team interactions are typically limited to those directly related to the assigned document (eg study management team meetings or kick-off/planning meetings relevant to a CSR). May schedule coordinate or participate in meetings to adjudicate comments or other matters related to the assigned document.
- Does effective and efficient project management.
- Works collaboratively with functional contributors (eg Clinical Research Biometrics Virology) ensuring all source information/data are appropriately reported in terms of accuracy completeness and scientific interpretation and in accordance with project timelines
- Coordinates the compilation of final documents and appendices that are provided by other functions
Education and Experience:
- Requires an extensive relevant experience in authoring clinical or regulatory documents for submission within the pharmaceutical/biotechnology industry
- Excellent verbal communication skills and attention to detail shows flexibility in communication style to work effectively with various teams
- Knowledgeable of regulatory document requirements and guidelines
- Well-developed computer skills including proficiency in Word Adobe Excel and the Regulatory Document Management System
Employement Category:
Employement Type: Full timeIndustry: Bio Technology & Life Sciences
Functional Area: Pharmaceutical
Role Category: Documentation
Role/Responsibilies: Medical Writer
Contact Details:
Company: Golden OpportunitiesLocation(s): Chennai
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