PPD is a leading global contract research organization providing discovery, development and post-approval services as well as compound partnering programs. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 32 countries and more than 9,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help its clients and partners maximize returns on their R&D investments and accelerate the delivery of safe and effective therapeutics to patients.
Post : Medical Writer
Summarized Purpose
Provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. Collaborates with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.
Essential Functions:
• Serves as primary author who writes and provides input on routine documents such as abstracts, posters, standard response letters, manuscripts, clinical study reports, and study protocols, and summarizes data from post-approval/MARO studies.
• May assist with unique and/or more complex clinical and scientific and program level documents, such as customized written responses, REMS/RMPs, and review articles.
• Ensures compliance with quality processes and requirements for assigned documents. May assist in determining best practices, methods and techniques for achieving optimal results.
• May assist in program management and/or proposal activities. Duties could include assisting with developing timelines, budgets, and forecasts for assigned deliverables.
• Represents the department at project launch meetings, review meetings, and project team meetings.
Knowledge, Skills and Abilities:
• Effective medical writing skills, including grammatical, editorial, and proofreading skills
• Ability to interpret and present complex data accurately and concisely
• Effective administrative, organizational, and planning skills; attention to detail and quality
• Ability to work on own initiative and effectively within a team
• Effective oral and written communication skills
• Working knowledge of regulations applicable to project work as well as drug development process
• Sound judgment and decision-making skills
• Good computer skills and skilled with the use of document templates
• Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
Physical Requirements:
• Ability to work in an upright and /or stationary position for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others to obtain or relate information to diverse groups.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance.
Additional Information:
Location: Haryana-New Delhi
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Medical Writer
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