Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife.
Post : Junior Manager - Medical Writing
Job Description
Job Purpose : To help in preparation of clinical trial related documents like synopsis, protocol, Risk Evaluation and Mitigation Strategies (REMS), Informed Consent Document (ICD), Clinical Study Report (CSR), Common Technical Document (CTD), electronic CTD (eCTD) modules and any other document as needed for regulatory submission/requested by sponsor
Key Responsibilities :
• Independently develop and finalize clinical and scientific documents such as (but not limited to) synopses, protocols, investigator brochures, Clinical Study Reports (CSRs), Informed Consent Documents (ICDs), relevant regulatory documents and clinical documents, Electronic Common Technical Document (eCTD) modules, etc. covering various therapeutic areas and all phases of clinical research
• Performs literature search/review as necessary to obtain background information for developing scientific content
• Collaborates with internal and external clients to support and enable effective communication resulting in operational excellence
• Effectively manages medical writing and review processes to deliver quality projects in agreed timelines
• Ensure compliance to applicable regulatory guidelines, department SOPs, client style guides, conventions as applicable
• Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables and responds to findings
• Follow any other instructions and perform any other related duties, as assigned by the supervisor.
• Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety
Candidate Profile
• Ability to comprehend scientific information
• Good understanding of clinical research.
• Knowledge of working on MS word, PPT etc.
• Attend training on environment, health, and safety (EHS) measures imparted company
Additional Information
Experience : 3-6 Years
Qualification : M.Pharma, M.sc, Ph.D
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Medical & Regulatory Affairs
End Date : 20th february, 2021
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