Medical Writer
2 weeks ago
**Responsibilities**
- Provides input for proposals as well as medical writing deliverables and attend BID defense meeting along with part of diligence meetings and audits
- Project Management of projects for Protocol, CSR and narratives by providing effective project management activities for clinical documents to ensure seamless delivery and high levels of customer satisfaction by driving process efficiencies.
- Effectively lead Medical Writing team and build expertise across different document types assigned
- Prepare and review Scientific and Medical and clinical documents (such as CSRs, RMP, DSUR, eCTD modules, narratives) having high quality of scientific content, data accuracy, and in compliance with regulatory guidelines, standard operating procedure, templates and style guides within established timelines
- Responsible for resource recruitment, allocation, and capacity utilization for the assigned teams to efficiently manage workload.
- Impart knowledge of documented guidelines and SOP standards.
- Plays a role of Medical and Safety Monitor, by preparation various plans (such as Medical Monitoring, eligibility assessment form / randomization forms, as applicable)
- Preparation of safety reporting presentations for the investigator’s meeting (IM) and site initiation visit (SIV) and if required making presentation at the IM.
- Training of the project team on Protocol, Therapeutic area and safety requirements of the study.
**Education & Experience**
- MBBS, or MD with relevant experience in Global Clinical Trials, having worked in Clinical Research, Pharma, Biotech
- 6-8 years of prior experience in medical writing, focused on CSR, Narratives etc.
- Experience in statistical data elaboration from medical view point
- Experience in publication and manuscript writing
- Travel when required
**Skills**
- Critical and Strategic Thinking, Problem Solving, Conflict Management
- Excellent knowledge of all operational and medical writing aspects of clinical research
- Excellent interpersonal, verbal and written communication skills with a deep understanding of communication across cultures and ability to communicate effectively with Sponsor
- Leverages communication and uses multiple communication mechanisms to convey information across functional lines and upward.
- Proficient in Microsoft Excel, Power Point, and Word
- Trained on ICH GCP
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