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Thursday, 17 March 2016

Opportunity to work as Medical Writer I/II @ inVentiv Health Clinical

Job Description


Develop clinical regulatory documents, including study reports, protocols, Master Informed Consent forms, and investigator brochures.
Write other types of documents such as medical information letters, clinical trial registry records, patient information brochures, news reports, press releases, image brochures, product monographs, or review articles.
Develop tables, charts, figures, and other display elements for clinical data.
Contribute to document quality checks, formatting, and comment consolidation.
Address team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format.
Comply with client or company procedures for completing deliverables, obtaining reviews, incorporating edits, and working with teams to complete/finalize deliverables.
Keep supervisor and team members informed of project status.
Participate in team meetings.
Working knowledge of drug development process and regulatory guidelines.
Continue professional development to keep pace with regulatory guidance and client expectations, and to improve skills.
Stay aware of the budget specifications for all assigned projects, working within the budgeted hours and communicating any changes to medical writing leadership.
Complete all administrative tasks within specified timeframes.
Develop and maintain good working relationships with internal and external colleagues
Responsible for performing activities that are in compliance with applicable Corporate and Divisional Policies, Standard Operating Procedures and Operating Guidelines and performing other duties as assigned by management



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