Senior Research Analyst - Medical Writing

Senior Research Analyst - Medical Writing

Position Description

Job Responsibilities:

•  Individual Contributor Role, however possess an established ability to work independently or as part of the team
•  Write regulatory-based documents (protocols, clinical study reports including patient narratives, annual safety reports, periodic safety update reports, integrated safety and efficacy reports, clinical trial registry summaries, and submission documents) for submission to regulatory agencies and medical institutions
•  Write clinical documents associated with submissions to regulatory authorities including but not limited to: model informed consents, interim and final clinical study reports, and safety update reports 
•  Ensure document content and style adheres to FDA/EMA/world-wide regulatory agencies or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and style guidelines.
•  Conduct quantitative and qualitative analyses on findings and present and interpret results in a structured, conclusion-oriented manner, to address key project objectives
•  Perform literature searches/reviews as necessary to obtain background information and training for development of documents.

Requirements

Desired Profile:

•  2-4 years of relevant experience in large Pharma / Healthcare organizations (or) Service providers servicing large Pharma / Clinical research organization
•  1-2 years core-experience with medical writing 
• Understanding of Data Analysis stream of work & exposure to analytical tools.
• Self-starter and ability to articulate customer problems/ requirements in a systemic way and devise service strategy as appropriate.
• Exposed to using data from secondary data-bases like PubMed, Embase, Medline, Thomson Pharma, Cochran reviews etc. for project requirement
•  Excellent communication skills to engage clients & team members alike & instill required enthusiasm... sound client management & team management skills
•  Has proven demonstration of competency in writing clinical study reports, patient narratives, protocols, informed consent etc.
•  Advanced degree in pharmacy, life sciences, microbiology, marketing 
•  Ability to travel as needed (including internationally)

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