PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 18,500 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health.
Job Title : Medical Writer- Homebased Opportunity
Experience : 4 – 9 Years
Location : Bengaluru/Bangalore, Mumbai, Chennai, Pune, Hyderabad / Secunderabad
Job Description :
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 and Other Job Information:
- Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols, and summarizes data from clinical studies.
- May assist with more complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
- 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 activities. Duties could include assisting with developing timelines, budgets, forecasts for assigned deliverables.
- Represents the department at project launch meetings, review meetings, and project team meetings.
Desired Profile
- Bachelor’s degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification
- Previous experience of 4-8 years that provides the knowledge, skills, and abilities to perform the job
- Experience working in the pharmaceutical/CRO industry preferred
- Experience in scientific writing advantageous
Knowledge, Skills and Abilities:
- Solid 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
- Good knowledge of regulatory documentation and drug development process
- Great judgment and decision-making skills
- Good computer skills and skilled with client templates;
- Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
