Human Resources (HR) at Vedic Lifesciences Pvt Ltd
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Senior Medical Writer - Clinical Trial (3-8 yrs)
Position Summary :
This role provides high-quality medical and scientific writing from planning and coordination of literature search through the delivery of final drafts to clients. Provides technical consultation and provides advice on strategy, regulations, and industry best practices.
Key Skills and attributes :
- Ability to effective manage medical writing projects to deliver products in agreed timelines.
- Collaboration with clients, supporting and enabling effective and efficient communication that results in operational excellence.
Job Responsibilities :
- Preparation of Protocol and investigator's brochure.
- Preparation of other study-related documents and revision of CSR.
- Publishing Paper.
- Reviewing and approving the SAP and engaging with the statistician for data analysis.
- White paper and scientific content writing.
- Literature Writing.
- Experience in Phase Clinical Trails, no BA/BE trials.
Minimum Education Level/ Years of experience:
- Medical, Pharma, Lifesciences Graduate with knowledge of Clinical Research.
- Minimum 3-8 years of experience of medical writing in CRO/Pharmaceutical/ Nutraceutical industry.
- Relevant background to understand and analyze human physiology.
- Capability to develop Clinical Trial protocols, IB and Clinical study report.
- Solid medical writing skills, including grammatical, editorial, and proofreading skills.
- Ability to work on own initiative and effectively within a team.
- Effective verbal and written communication skills.
- Good knowledge of document management systems and other relevant applications (e.g. Word, Excel, Outlook, etc).
- Effective administrative, organizational, and planning skills; attention to detail and quality.