PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.
Post : Medical Writer I
Job Description
• Research, create, edit, and coordinate the development of independent review charters (IRC), reviewer manuals, imaging case report forms (CRFs), and other clinical documents intended for submission to the FDA or other regulatory authorities. Also responsible for the development of these or other documents which may not be submitted to the FDA or other regulatory authorities but are recommended to ensure the quality and consistency of independent reviews.
• Serve as the main client contact for IRC development, including presenting and leading client discussions
• Combine understanding of current product offerings and existing solutions with knowledge of medical and scientific concepts in order to meet the customer’s requirements
• Ensure that standards as described in department documentation upholds the following goals: increased efficiency, enhanced document quality, and content and format standardization
Candidate Profile
• Bachelor’s degree in Life Sciences/Health Related Sciences (minimum)
• Excellent written and oral communication and interpersonal skills
• Knowledge of the drug development process essential
• Knowledge of GCP/ICH guidelines and the clinical trials process
• Strong word processing and Microsoft Office Suite skills: advanced skills in Microsoft Word and proficiency in Excel and PowerPoint
• Excellent organizational skills to work with the vast array of information gathered during document development and to cope with rapidly changing information
• Ability to work in a high pressure, result/deadline oriented environment
• Ability to interact with multiple organizations (internal and external) concurrently
• Flexible attitude with respect to work assignments and new learning
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
• Working knowledge of formal software development methodologies is preferred
Additional Information:
Location: Hyderabad
Qualification : Bachelor’s degree in Life Sciences
Functional Area: Medical Writer
Industry Type: Pharma/ Biotech/Clinical Research
End Date: 10th January, 2018
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