Job Description :
Job Description
Job Description for Medical Writer:

Experience required: 10-12 years.

Prepare documents that present clinical data objectively in a clear, concise format. The incumbent must show competence in writing, editing, and reviewing Clinical Study Reports (CSRs) and other clinical documents like

1. Summary Documents
2. eCTD Submission Documents
3. Clinical Overview
4. Safety & Efficacy reports
5. Risk Management Plan

Development and updating of Investigator’s Brochures, Clinical Study Protocols, and other regulatory documents
Analysis, interpretation, and accurate presentation of information or data in text, table, or figure format
Provide dedicated scientific authoring expertise to both the development and research groups.
May need to liaise with external services and review documentation generated elsewhere (e.g., Clinical Research Organizations [CROs], subsidiaries, co-development partners), and internal support staff (e.g., for the preparation of tables, illustrations, and appendices
Quality-checking documents for agreement between in-text information and the source data
Prepare reports, manage review cycles, and incorporate comments as appropriate.
Provision of overall medical writing support for ongoing programs

Scientific degree, preferably PhD, or medically qualified, or with equivalent relevant experience.
Experience (preferably 7+ years) as MW, or equivalent, or presenting relevant qualifications.
Experience Preferred in Therapeutic areas like - Oncology, Neurology, Cardiovascular (Not Mandatory)
Very good verbal and written English skills
High degree of accuracy with attention to detail
Excellent analytical and problem solving skills
Good level of computer literacy, in particular in the use word, excel and databases
Personal skills: good communication, presentation, flexibility, time management and
Ability to work independently and proactively within a team.
Ability to work on multiple projects simultaneously, while maintaining